Acupuncture Therapy in a Group Setting for Chronic Pain

Acupuncture Therapy in a Group Setting for Chronic Pain Abstract Objective This project was designed to test the feasibility and effectiveness of acupuncture therapy given in a group setting for chronic pain. Design Nonrandomized, repeated measures quasi-experimental trial. Setting Care was delivered in a primary care clinic waiting area after clinic hours. Subjects Included were primary care patients (≥18 years old) with chronic pain of the neck, back, shoulder, or osteoarthritis of any site of at least three months’ duration. Methods Subjects received eight weekly acupuncture therapy sessions in a group setting. Acupuncture therapy included a combination of palpation, acupuncture needling, Tui na, Gua sha, and auricular treatment. Baseline pain levels were established in a two- to four-week run-in; assessment of the intervention impact on pain intensity, mood, and functional status were made at the end of the treatment period (eight weeks) and 16 weeks after completion of intervention (24 weeks). Results Of the total 113 participants recruited for the trial, 96 completed the 24-week protocol. We found a statistically and clinically significant decrease in pain severity, pain interference, and depression in our study population. There were no serious adverse events. Conclusions Acupuncture therapy offered in the group setting was effective in reducing pain severity, pain interference, and depression in patients with chronic neck, back, or shoulder pain or osteoarthritis. Benefit persisted through the 24-week measure despite no additional treatment. This finding has potentially important implications for improving access to effective acupuncture treatment for patients with limited financial resources. Acupuncture, chronic pain, complementary medicine Background The prevalence of chronic pain problems in the general adult US population is high; estimates have ranged from 10% to 40% in recent large surveys depending on the specific sample [1–4]. Research has also documented a positive association between pain and impairment in physical and psychological functioning [5,6], lost work productivity [7], and lower socioeconomic status [8]. There is substantial evidence that minority and poor populations differ both in the prevalence and outcomes of chronic pain [2,8–11]. In addition, race/ethnicity and socioeconomic factors influence access to pain care [10,12–14]. A great deal of evidence now supports the use of acupuncture therapy in the treatment of chronic pain conditions [15,16], including shoulder pain [17,18], osteoarthritis [19–23], neck pain [24–26], and low back pain [26–28]. Acupuncture is recommended as a firstline treatment by the American College of Physicians in their 2017 Clinical Practice Guidelines for acute and chronic low back pain and by the National Institutes of Health for low back pain and knee osteoarthritis [29,30]. Although the mechanism of action remains complex and some studies find both “sham” (needles in nonacupuncture points) and real acupuncture to be effective, studies also show that 40% to 50% of patients experience a reduction in pain with acupuncture treatment with some evidence of persistence in pain reduction in the long term from real acupuncture [31]. Most acupuncture therapy is delivered in individual practitioner-patient sessions. Patients from lower socioeconomic groups are generally not able to access acupuncture treatment in the United States; services are not generally reimbursed by insurers, and patients often cannot afford the out-of-pocket expense. Therefore, cost and access pose a major barrier to widespread implementation in this patient population. Acupuncture care delivered in a group or community setting has been shown to be feasible for patients with chronic pain including patients from lower socioeconomic groups [32–34]. There is some evidence of effectiveness of acupuncture therapy in groups for knee osteoarthritis [35] and peripheral neuropathy [36,37], but other chronic pain conditions have not been studied in a group setting. Formalized auricular acupuncture given in a group setting has been used extensively in the treatment of substance abuse disorders [38,39]. This project was designed to test the feasibility and effectiveness of group acupuncture for the treatment of back pain, shoulder pain, neck pain, and osteoarthritis. The goal of this project was to develop and pilot a low-cost, effective integrative intervention for chronic pain that, if found to be effective, could be replicated easily in underserved settings across the United States. Methods Setting and Subjects This study was approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board. We recruited outpatients with chronic pain from local primary care practices in New York City. Chronic pain was defined as pain that persisted for at least three months’ duration. After a two- to four-week run-in period to establish average baseline pain levels, participants were offered an eight-week, group-based acupuncture treatment intervention. We evaluated the impact of this intervention on pain intensity, mood, and functional status, as well as the effects on analgesic use. Patients age 18 years or older were eligible to participate in this study if they had chronic pain due to a qualifying diagnosis of back pain, shoulder pain, neck pain, and/or osteoarthritis. In addition, participants had to 1) understand English 2) be able to provide phone numbers to facilitate scheduling, 3) be available for up to eight weekly treatments and 16 weeks of follow-up post-treatment, 4) have not received acupuncture treatment within the past three months, and 5) have no severe psychiatric problems that could interfere with the ability to receive treatment in a group setting. Design The study used a repeated measures quasi-experimental design. The multiple pretreatment measurement points during the run-in period allowed us to document and monitor the typically variable patterns of pain pre-intervention. This design optimized feasibility and acceptability to patients and participating health centers while still generating meaningful outcome data. Specifically, we did not propose randomization within the practices, rather allowing clinicians to offer the intervention to all patients with target diagnoses who meet eligibility criteria. Intervention The intervention consisted of eight weekly sessions of acupuncture therapy in a group setting provided by licensed acupuncturists. Appointments were staggered every 15 minutes; each subject was present for 40 to 60 minutes total, with the treatment lasting from 20 to 40 minutes. Group sessions were scheduled to accommodate up to eight subjects per session. Sessions were conducted in the late afternoon and evening by the same acupuncturist; the study care was delivered by two acupuncturists (CK and TS), each with over 10 years’ clinical experience. Study sessions were often assisted by a student acupuncturist or additional acupuncturist who helped greet patients but was not directly involved in patient care. Our intervention manual was developed using a modified Delphi process over two months with a team of acupuncturists experienced in individual and group acupuncture care for chronic pain including current and former fellows of the Acupuncture Fellowship for Inpatient Care at Mount Sinai Beth Israel. Participants had trained in the United States, China, and Vietnam. Our approach consisted of real-world acupuncture therapy options and combinations: assessment, palpation, Tui Na, Gua sha, acupuncture needling, auricular treatment, and simple diet and lifestyle recommendations based in traditional East Asian medicine allowing treatment to be shaped to individual patients’ needs through time. Common points were needled based on the patient’s presentation, with optional points selected based on palpation of channels. Points were needled to obtain “de qi,” which can be felt by the patient and practitioner, sometimes with fasciculation and/or a grabbing of the needle as it is manipulated, representing fibril “whorling” within the connective tissue and mechanical propagation of the signal along channels or connective tissue planes. Noncoated acupuncture needles were used to maximize the connective tissue response and analgesic effect [40–44]. Non-needling techniques were also used in the approach, including Tui Na, manual therapy often used in conjunction with acupuncture, particularly for muscle and joint pain, and Gua sha, defined as instrument-assisted closely timed unidirectional press-stroking of a lubricated area of the body surface to intentionally create transitory therapeutic petechiae called “sha,” representing extravasation of blood in the subcutis [45]. In Tui Na, specific applications are used to stimulate, relax, warm, and irrigate channels in or associated with painful areas [46]. In traditional East Asian medicine, acupuncture channels or meridians represent both the vertical and horizontal pathways connecting the surface of the body to internal tissues and organs. Acupuncture channels and points have more recently been associated with connective tissue planes [44], and their stimulation to a global physiologic network [47]. Tui Na can be especially useful if the subject is new to acupuncture therapy and/or has a fear of needles. Gua sha is used to resolve the condition known as “blood stasis” in Chinese medicine, which is associated with persistent, fixed, or recurring pain. Gua sha mechanically stretches the subcutaneous fascia, and the production and resolution of “sha petechiae” upregulates heme oxygenase-1 (HO-1), producing an anti-inflammatory and immune protective effect locally and systemically over a period of days following treatment [26,48–50]. Gua sha was delivered using single-use disposable metal caps [51] and a plain nonmedicated balm. Auricular treatment included ear needling and pressure applied to points on the ear with pretaped seeds or sphere magnets retained between sessions. Auricular therapy has been shown to be an effective treatment for acute and chronic pain [52,53]. We instructed patients to arrive for treatment hydrated and having eaten something within the last hour to reduce the incidence of presyncope. We asked patients to wear loose clothing so that the neck, shoulders, upper back, forearms, and forelegs were accessible to touch. Our sessions were conducted in a comfortable clinic waiting area after clinic hours. Patients were either seated in soft chairs or on a couch. Data Collection We had two primary outcome measures. The Brief Pain Inventory–Short Form (BPI) [54] is a nine-item measure that asks patients to indicate, over the past 24 hours, the level of pain they are feeling, the intensity of pain, and how their pain influences select aspects of their everyday life, that is, mood, walking, sleep, and their ability to work. The Center for Epidemiological Studies–Depression Scale (CES-D) [55] is a well-validated, 20-item measure of depressive symptoms. Secondary outcome measures included the Patient Global Impression of Change (PGIC), a single-question seven-point categorical scale that captures a patient’s experience of treatment at baseline and follow-up points and pain-free days, a self-report measure used in previous pain research. Patients were asked to report the number of pain free days in the previous two weeks. We also examined medication utilization, asking participants at baseline and week 1, week 8, and week 24 to report their use of pain medications over the prior two-week period. Measures were collected over the 24-week study period as per the schedule in Table 1. Table 1 Data collection Measure  Baseline  Pre 1  Week 1  Week 8  Week 12  Week 24  BPI  X  X  X  X  X  X  CES-D  X    X  X  X  X  Pain-free days  X  X  X  X  X  X  PGIC        X  X  X  Demographics  X            Medication use  X    X  X    X  Measure  Baseline  Pre 1  Week 1  Week 8  Week 12  Week 24  BPI  X  X  X  X  X  X  CES-D  X    X  X  X  X  Pain-free days  X  X  X  X  X  X  PGIC        X  X  X  Demographics  X            Medication use  X    X  X    X  BPI = Brief Pain Inventory–Short Form; CES-D = Center for Epidemiological Studies–Depression Scale; Pre = pre-acupuncture; Week 1 = first acupuncture visit. Analysis Pain severity was measured using four BPI questions related to worst, least, average, and current pain. Each question was scaled from 0 (no pain) to 10; the answers were summed to form the scale pain severity measure. The multiple baseline (pre-intervention) measures were averaged for a single baseline measure. Pain interference was measured using four BPI questions related to worst, least, average, and current pain. Each question was scaled from 0 (no pain) to 10, and these were summed to form the scale pain interference measure. The multiple baseline (pre-intervention) measures were averaged for a single baseline measure. For the BPI, we also measured percent change from baseline to 24 weeks to identify those with at least a 30% change over that period. Depression was measured as the sum of the 20 CES-D questions (scored 0–10). Sociodemographic factors and baseline health indicators were examined comparing those patients who completed the 24-week follow-up (N = 96) with those who initiated treatment but either withdrew from or were lost to follow-up (N = 9) using the Fisher exact test for proportion and t test to compare means. Patients who enrolled in the study but never initiated treatment were omitted entirely from the analysis (N = 8). To compare average pain severity, pain interference, and depression scores over time, repeated measures GLM were used applying a Greenhouse-Geisser correction when the spherocity assumption was violated by the data. Additionally, baseline and 24-week outcomes were compared using repeated measures t tests. Data were entered, coded, and analyzed in SPSS v. 24. As there were no statistically significant differences between the eight- and 12-week outcomes on any of the measures, we have presented the data as baseline, midpoint, and end point to maximize the number of patients included in the analysis. For subjects (N = 85) who had both eight- and 12-week data, we averaged the values for analysis. To compare self-reported past two-week pain medication use from baseline to eight weeks and baseline to 24-week post-treatment, we used Pearson’s chi-square test of proportions. Results We recruited a total of 113 participants for the trial, 96 of whom completed the 24-week protocol. Eight patients never initiated the study intervention. Of the remaining nine subjects, two patients withdrew, one patient moved away after three sessions, one had surgery and could not complete the study, and five could not be reached for the 24-week follow-up. Our average age was 54.4 years, and the ethnic makeup of our study sample was representative of the New York City population. There were no significant differences between study completers and noncompleters in any category, including pain severity or depression at baseline. The majority of our participants were insured, with 30.6% of those on Medicaid or Medicare. Outcome results below represent the 96 study participants who completed the 24-week term of the trial. Demographics for the two groups are presented in Table 2. Table 2 Study demographics     Completed (N = 96)  LTFU (N = 9)  P      No. (%)  No. (%)    Ethnicity  Hispanic  25 (26.0)  2 (22.2)  1.00    Non-Hispanic  70 (72.9)  7 (77.8)      Missing  1 (0.1)  0 (0.0)    Race  Asian  8 (8.3)  1 (11.1)  0.41    Black/African American  13 (13.5)  3 (33.3)      Other  18 (18.7)  1 (11.1)      White  53 (55.2)  4 (44.4)      Missing  4 (4.2)  0 (0.0)    Education  Did not graduate high school  2 (2.1)  0 (0.0)  0.62    High school graduate  6 (6.3)  1 (11.1)      Some college  16 (16.7)  2 (22.2)      College graduate or greater  71 (74.0)  6 (66.7)      Missing  1 (1.0)  0 (0.0)    Work status  Full time  56 (58.3)  6 (66.7)  0.37    Part time  9 (9.4)  0 (0.0)      Retired  17 (17.7)  0 (0.0)      Student  2 (2.1)  0 (0.0)      Disabled  4 (4.2)  1 (11.1)      Unemployed  5 (5.2)  1 (11.1)      Missing  3 (3.1)  1 (11.1)    Income  <$20,000  10 (10.4)  2 (22.2)  0.86    $20,000–$49,000  26 (27.0)  1(11.1)      $50,000+  45 (46.9)  5 (55.6)      Don’t know/refused/missing  15 (15.6)  1 (11.1)    Receiving routine medical care  Yes  85 (88.5)  9 (100.0)  0.59    No  11 (11.5)  0 (0.0)    Insurance type  Private  57 (59.4)  7 (77.8)  0.77    Fee-for-service  1 (1.0)  0 (0.0)      Medicaid  12 (12.5)  0 (0.0)      Medicare  17 (17.7)  2 (22.2)      N/A or missing  9 (9.4)  0 (0.0)    Disability  Yes  6 (6.3)  1 (11.1)  0.48    No  89 (92.7)  8 (88.9)      Missing  1 (1.0)  0 (0.0)      Mean (SD)  Mean (SD)    Age, years  54.0 (15.5)  44.7 (12.8)  0.09  Baseline pain severity  5.0 (1.7)  5.3 (2.0)  0.59  Baseline pain interference  3.7 (2.1)  4.7 (2.1)  0.13  Baseline 2-week pain-free days  1.5 (2.1)  1.7 (3.5)  0.75  Baseline depression  13.7 (9.0)  17.6 (12.2)  0.23      Completed (N = 96)  LTFU (N = 9)  P      No. (%)  No. (%)    Ethnicity  Hispanic  25 (26.0)  2 (22.2)  1.00    Non-Hispanic  70 (72.9)  7 (77.8)      Missing  1 (0.1)  0 (0.0)    Race  Asian  8 (8.3)  1 (11.1)  0.41    Black/African American  13 (13.5)  3 (33.3)      Other  18 (18.7)  1 (11.1)      White  53 (55.2)  4 (44.4)      Missing  4 (4.2)  0 (0.0)    Education  Did not graduate high school  2 (2.1)  0 (0.0)  0.62    High school graduate  6 (6.3)  1 (11.1)      Some college  16 (16.7)  2 (22.2)      College graduate or greater  71 (74.0)  6 (66.7)      Missing  1 (1.0)  0 (0.0)    Work status  Full time  56 (58.3)  6 (66.7)  0.37    Part time  9 (9.4)  0 (0.0)      Retired  17 (17.7)  0 (0.0)      Student  2 (2.1)  0 (0.0)      Disabled  4 (4.2)  1 (11.1)      Unemployed  5 (5.2)  1 (11.1)      Missing  3 (3.1)  1 (11.1)    Income  <$20,000  10 (10.4)  2 (22.2)  0.86    $20,000–$49,000  26 (27.0)  1(11.1)      $50,000+  45 (46.9)  5 (55.6)      Don’t know/refused/missing  15 (15.6)  1 (11.1)    Receiving routine medical care  Yes  85 (88.5)  9 (100.0)  0.59    No  11 (11.5)  0 (0.0)    Insurance type  Private  57 (59.4)  7 (77.8)  0.77    Fee-for-service  1 (1.0)  0 (0.0)      Medicaid  12 (12.5)  0 (0.0)      Medicare  17 (17.7)  2 (22.2)      N/A or missing  9 (9.4)  0 (0.0)    Disability  Yes  6 (6.3)  1 (11.1)  0.48    No  89 (92.7)  8 (88.9)      Missing  1 (1.0)  0 (0.0)      Mean (SD)  Mean (SD)    Age, years  54.0 (15.5)  44.7 (12.8)  0.09  Baseline pain severity  5.0 (1.7)  5.3 (2.0)  0.59  Baseline pain interference  3.7 (2.1)  4.7 (2.1)  0.13  Baseline 2-week pain-free days  1.5 (2.1)  1.7 (3.5)  0.75  Baseline depression  13.7 (9.0)  17.6 (12.2)  0.23  LTFU = Lost to Follow Up. We had complete data on a total of 95 subjects on pain severity, 94 on pain interference, and 95 on the depression outcome. Using the generally accepted definition of a clinically significant change in pain being a 30% decrease from baseline, we found a statistically and clinically significant decrease in both pain severity and pain interference in our study population. This difference not only persisted beyond the eight-week end-of-treatment time point, but continued to increase through the 24-week measure despite no additional treatment. Pain severity decreased from 4.92 (95% confidence interval [CI] = 4.58–5.26) at baseline to 2.72 (95% CI = 2.19–3.32; P < 0.01) at 24 weeks. Pain interference decreased from 3.59 (95% CI = 3.17–4.01) at baseline to 1.87 (95% CI = 1.38–2.37; P < 0.01) at 24 weeks. Fifty-five out of 95 patients (57.8%) showed at least a 30% reduction in pain severity, and 64 out of 94 patients (68.0%) showed at least a 30% reduction in pain interference. The average number of acupuncture sessions completed was 6.7. Changes in pain severity and pain interference are shown in Figures 1 and 2. Figure 1 View largeDownload slide Brief Pain Inventory–Short Form pain severity. BPI = Brief Pain Inventory–Short Form. Figure 1 View largeDownload slide Brief Pain Inventory–Short Form pain severity. BPI = Brief Pain Inventory–Short Form. Figure 2 View largeDownload slide Brief Pain Inventory–Short Form pain interference. BPI = Brief Pain Inventory–Short Form. Figure 2 View largeDownload slide Brief Pain Inventory–Short Form pain interference. BPI = Brief Pain Inventory–Short Form. The number of pain-free days in the past two weeks also increased significantly during the course of the study from 1.4 (95% CI = 1.0–1.8); P < 0.01) at baseline to 4.8 (95% CI = 3.7–5.8; P < 0.01) at 24 weeks. Change in pain-free days is shown in Figure 3. Figure 3 View largeDownload slide Pain-free days. Figure 3 View largeDownload slide Pain-free days. Figure 4 View largeDownload slide Center for Epidemiological Studies–Depression Scale results. CES-D = Center for Epidemiological Studies–Depression Scale. Figure 4 View largeDownload slide Center for Epidemiological Studies–Depression Scale results. CES-D = Center for Epidemiological Studies–Depression Scale. We also found a statistically and clinically significant decrease in depression from baseline to 24 weeks as measured by the CES-D. The mean score at baseline was 13.47 (95% CI = 11.67–15.27) as compared with 9.79 (95% CI = 7.61–11.97; P < 0.01) at 24 weeks. The clinical significance of this change is less clear than with the pain measure as a cutoff of 16 on the CES-D is usually used as a threshold indicating a risk for clinical depression. As with the pain measures, the benefit in depression was maintained through the 24-week end point despite the fact that no additional treatment was offered after week 8. Depression results are shown in Figure 4. The PGIC measure decreased over the study period though the change did not reach clinical significance. Regarding medication use, we found that the proportion of subjects taking any type of pain medication over the previous two weeks fell from 87% at baseline to 65% at the 24-week mark (P < 0.01). However, the self-reported data on this outcome were too inconsistent to allow for analysis of specific medication categories. There were no serious adverse effects reported in this study and only infrequent minor adverse effects such as needle site irritation and bleeding and tiredness after treatment. Discussion Pain is a primary symptom that prompts health care seeking including for care by acupuncturists. Low back and neck pain were the leading causes of disability in 2015 in most countries [6], and approximately 12% of the US population age 25 to 74 years has clinically defined osteoarthritis (OA) of some joint [56]. There is evidence that acupuncture is effective for chronic pain including headache [57] and migraine [58], temporomandibular disorders [59] shoulder pain [17,18], pain of the lower back and neck, and osteoarthritis of the knee [15,16,19–30,60,61]. A 2016 meta-analysis of acupuncture trials for neck, lower back and shoulder pain, knee OA pain, and headache/migraine show that relief persists for 50% to 90% of responders even at 12 months’ post-treatment [31]. These trials, however, are of acupuncture given in individual sessions. The cost and lack of universal insurance coverage for acupuncture creates a significant barrier to access to individual acupuncture for patients from underserved and low–socioeconomic status populations; offering acupuncture therapy in the group setting is a potential solution to this access problem. Depression and other mental health comorbidities often contribute to disability and reduced quality of life in patients with chronic pain. Although studies are ongoing regarding the impact of acupuncture on depression, a 2010 systematic review with meta-analysis found acupuncture’s benefit to be similar to that of antidepressant medications [62]. A 2012 systematic review found that acupuncture alone was comparable with antidepressants or psychotherapy alone in the treatment of depression [63], and a 2013 systematic review found a high level of evidence to support the use of acupuncture in treating major depressive disorders in pregnancy [64]. A large-scale 2013 trial found that acupuncture and counseling can provide long-term benefits for many patients with ongoing depression in primary care [61,65]. Acupuncture is also shown to improve quality of life in patients with depression [66]. Group acupuncture (also known as “community acupuncture”) sessions and clinics have increased in the United States and in other countries to meet the demand for care by those who cannot afford out-of-pocket fees associated with individual session care. By group acupuncture here, we mean treating patients in turn in a shared setting, primarily seated in chairs proximal to one another. Patients may or may not interact with one another, but can hear conversation between other patients or between other patients and the practitioner. Although there are no official statistics on the number of community/group acupuncture clinics, as of 2012 at least 200 such programs were operating around the country, and this number has certainly grown at this point [67]. Group acupuncture has been studied for feasibility and quality of patient experience [67–70] for knee OA [34,35,70], for cancer pain, for peripheral neuropathy and digestive symptoms [36], to relieve radiation-induced xerostomia [71], and for pain and peripheral neuropathy in HIV patients [37]. However, no large-scale effectiveness trials of group acupuncture for chronic pain have been published to date. In previous work, we found it feasible and effective to deliver individual acupuncture sessions in an underserved primary care setting [32,33]. In this study, we confirm that acupuncture therapy in a group setting is feasible and effective in a primary care clinic in New York City. We found a significant reduction of chronic pain and depression over eight weeks of treatment. Perhaps more importantly, we found that this benefit was sustained through 24 weeks with no additional intervention despite the fact that our treatment intervention was only eight weeks long as opposed to the 12- to 16-week duration more common in clinical trials. These findings clarify that acupuncture therapy customarily given in an individual setting can reduce chronic pain and depression in patients with chronic pain when given in a group setting as well. Group acupuncture may therefore be considered a safe and effective option for chronic pain patients. Although our patient sample in this study was not exclusively drawn from a low-income or underserved population, there is no reason to assume that the pain outcomes we demonstrated here would not apply to these populations, potentially addressing the access issue that impacts those of a lower socioeconomic status. Limitations Our trial used a quasi-experimental design and did not have a control group. While acupuncture has been shown to be effective for chronic pain and depression in controlled trials, because of the lack of control group, we cannot definitively say that the acupuncture therapy was the discrete cause of the benefit to subjects here, as opposed to the nonspecific treatment effects of care or of participating in a group research project. A more ideal design would randomize between group and individual acupuncture, and in fact our current Patient-Centered Outcome Research Institute (PCORI)–funded effort, the Acupuncture Approaches to Decrease Disparities in Pain Treatment (AADDOPT-2) trial, is taking this approach in a randomized study of 700 patients receiving acupuncture at community health centers in the Bronx, New York. A second limitation in the present study was the lack of an effective strategy for collecting data on medication use, which is another important outcome potentially impacted by acupuncture treatment. 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Acupunct Med  2009; 27 3: 109– 13. Google Scholar CrossRef Search ADS PubMed  © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Pain Medicine Oxford University Press

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Abstract

Abstract Objective This project was designed to test the feasibility and effectiveness of acupuncture therapy given in a group setting for chronic pain. Design Nonrandomized, repeated measures quasi-experimental trial. Setting Care was delivered in a primary care clinic waiting area after clinic hours. Subjects Included were primary care patients (≥18 years old) with chronic pain of the neck, back, shoulder, or osteoarthritis of any site of at least three months’ duration. Methods Subjects received eight weekly acupuncture therapy sessions in a group setting. Acupuncture therapy included a combination of palpation, acupuncture needling, Tui na, Gua sha, and auricular treatment. Baseline pain levels were established in a two- to four-week run-in; assessment of the intervention impact on pain intensity, mood, and functional status were made at the end of the treatment period (eight weeks) and 16 weeks after completion of intervention (24 weeks). Results Of the total 113 participants recruited for the trial, 96 completed the 24-week protocol. We found a statistically and clinically significant decrease in pain severity, pain interference, and depression in our study population. There were no serious adverse events. Conclusions Acupuncture therapy offered in the group setting was effective in reducing pain severity, pain interference, and depression in patients with chronic neck, back, or shoulder pain or osteoarthritis. Benefit persisted through the 24-week measure despite no additional treatment. This finding has potentially important implications for improving access to effective acupuncture treatment for patients with limited financial resources. Acupuncture, chronic pain, complementary medicine Background The prevalence of chronic pain problems in the general adult US population is high; estimates have ranged from 10% to 40% in recent large surveys depending on the specific sample [1–4]. Research has also documented a positive association between pain and impairment in physical and psychological functioning [5,6], lost work productivity [7], and lower socioeconomic status [8]. There is substantial evidence that minority and poor populations differ both in the prevalence and outcomes of chronic pain [2,8–11]. In addition, race/ethnicity and socioeconomic factors influence access to pain care [10,12–14]. A great deal of evidence now supports the use of acupuncture therapy in the treatment of chronic pain conditions [15,16], including shoulder pain [17,18], osteoarthritis [19–23], neck pain [24–26], and low back pain [26–28]. Acupuncture is recommended as a firstline treatment by the American College of Physicians in their 2017 Clinical Practice Guidelines for acute and chronic low back pain and by the National Institutes of Health for low back pain and knee osteoarthritis [29,30]. Although the mechanism of action remains complex and some studies find both “sham” (needles in nonacupuncture points) and real acupuncture to be effective, studies also show that 40% to 50% of patients experience a reduction in pain with acupuncture treatment with some evidence of persistence in pain reduction in the long term from real acupuncture [31]. Most acupuncture therapy is delivered in individual practitioner-patient sessions. Patients from lower socioeconomic groups are generally not able to access acupuncture treatment in the United States; services are not generally reimbursed by insurers, and patients often cannot afford the out-of-pocket expense. Therefore, cost and access pose a major barrier to widespread implementation in this patient population. Acupuncture care delivered in a group or community setting has been shown to be feasible for patients with chronic pain including patients from lower socioeconomic groups [32–34]. There is some evidence of effectiveness of acupuncture therapy in groups for knee osteoarthritis [35] and peripheral neuropathy [36,37], but other chronic pain conditions have not been studied in a group setting. Formalized auricular acupuncture given in a group setting has been used extensively in the treatment of substance abuse disorders [38,39]. This project was designed to test the feasibility and effectiveness of group acupuncture for the treatment of back pain, shoulder pain, neck pain, and osteoarthritis. The goal of this project was to develop and pilot a low-cost, effective integrative intervention for chronic pain that, if found to be effective, could be replicated easily in underserved settings across the United States. Methods Setting and Subjects This study was approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board. We recruited outpatients with chronic pain from local primary care practices in New York City. Chronic pain was defined as pain that persisted for at least three months’ duration. After a two- to four-week run-in period to establish average baseline pain levels, participants were offered an eight-week, group-based acupuncture treatment intervention. We evaluated the impact of this intervention on pain intensity, mood, and functional status, as well as the effects on analgesic use. Patients age 18 years or older were eligible to participate in this study if they had chronic pain due to a qualifying diagnosis of back pain, shoulder pain, neck pain, and/or osteoarthritis. In addition, participants had to 1) understand English 2) be able to provide phone numbers to facilitate scheduling, 3) be available for up to eight weekly treatments and 16 weeks of follow-up post-treatment, 4) have not received acupuncture treatment within the past three months, and 5) have no severe psychiatric problems that could interfere with the ability to receive treatment in a group setting. Design The study used a repeated measures quasi-experimental design. The multiple pretreatment measurement points during the run-in period allowed us to document and monitor the typically variable patterns of pain pre-intervention. This design optimized feasibility and acceptability to patients and participating health centers while still generating meaningful outcome data. Specifically, we did not propose randomization within the practices, rather allowing clinicians to offer the intervention to all patients with target diagnoses who meet eligibility criteria. Intervention The intervention consisted of eight weekly sessions of acupuncture therapy in a group setting provided by licensed acupuncturists. Appointments were staggered every 15 minutes; each subject was present for 40 to 60 minutes total, with the treatment lasting from 20 to 40 minutes. Group sessions were scheduled to accommodate up to eight subjects per session. Sessions were conducted in the late afternoon and evening by the same acupuncturist; the study care was delivered by two acupuncturists (CK and TS), each with over 10 years’ clinical experience. Study sessions were often assisted by a student acupuncturist or additional acupuncturist who helped greet patients but was not directly involved in patient care. Our intervention manual was developed using a modified Delphi process over two months with a team of acupuncturists experienced in individual and group acupuncture care for chronic pain including current and former fellows of the Acupuncture Fellowship for Inpatient Care at Mount Sinai Beth Israel. Participants had trained in the United States, China, and Vietnam. Our approach consisted of real-world acupuncture therapy options and combinations: assessment, palpation, Tui Na, Gua sha, acupuncture needling, auricular treatment, and simple diet and lifestyle recommendations based in traditional East Asian medicine allowing treatment to be shaped to individual patients’ needs through time. Common points were needled based on the patient’s presentation, with optional points selected based on palpation of channels. Points were needled to obtain “de qi,” which can be felt by the patient and practitioner, sometimes with fasciculation and/or a grabbing of the needle as it is manipulated, representing fibril “whorling” within the connective tissue and mechanical propagation of the signal along channels or connective tissue planes. Noncoated acupuncture needles were used to maximize the connective tissue response and analgesic effect [40–44]. Non-needling techniques were also used in the approach, including Tui Na, manual therapy often used in conjunction with acupuncture, particularly for muscle and joint pain, and Gua sha, defined as instrument-assisted closely timed unidirectional press-stroking of a lubricated area of the body surface to intentionally create transitory therapeutic petechiae called “sha,” representing extravasation of blood in the subcutis [45]. In Tui Na, specific applications are used to stimulate, relax, warm, and irrigate channels in or associated with painful areas [46]. In traditional East Asian medicine, acupuncture channels or meridians represent both the vertical and horizontal pathways connecting the surface of the body to internal tissues and organs. Acupuncture channels and points have more recently been associated with connective tissue planes [44], and their stimulation to a global physiologic network [47]. Tui Na can be especially useful if the subject is new to acupuncture therapy and/or has a fear of needles. Gua sha is used to resolve the condition known as “blood stasis” in Chinese medicine, which is associated with persistent, fixed, or recurring pain. Gua sha mechanically stretches the subcutaneous fascia, and the production and resolution of “sha petechiae” upregulates heme oxygenase-1 (HO-1), producing an anti-inflammatory and immune protective effect locally and systemically over a period of days following treatment [26,48–50]. Gua sha was delivered using single-use disposable metal caps [51] and a plain nonmedicated balm. Auricular treatment included ear needling and pressure applied to points on the ear with pretaped seeds or sphere magnets retained between sessions. Auricular therapy has been shown to be an effective treatment for acute and chronic pain [52,53]. We instructed patients to arrive for treatment hydrated and having eaten something within the last hour to reduce the incidence of presyncope. We asked patients to wear loose clothing so that the neck, shoulders, upper back, forearms, and forelegs were accessible to touch. Our sessions were conducted in a comfortable clinic waiting area after clinic hours. Patients were either seated in soft chairs or on a couch. Data Collection We had two primary outcome measures. The Brief Pain Inventory–Short Form (BPI) [54] is a nine-item measure that asks patients to indicate, over the past 24 hours, the level of pain they are feeling, the intensity of pain, and how their pain influences select aspects of their everyday life, that is, mood, walking, sleep, and their ability to work. The Center for Epidemiological Studies–Depression Scale (CES-D) [55] is a well-validated, 20-item measure of depressive symptoms. Secondary outcome measures included the Patient Global Impression of Change (PGIC), a single-question seven-point categorical scale that captures a patient’s experience of treatment at baseline and follow-up points and pain-free days, a self-report measure used in previous pain research. Patients were asked to report the number of pain free days in the previous two weeks. We also examined medication utilization, asking participants at baseline and week 1, week 8, and week 24 to report their use of pain medications over the prior two-week period. Measures were collected over the 24-week study period as per the schedule in Table 1. Table 1 Data collection Measure  Baseline  Pre 1  Week 1  Week 8  Week 12  Week 24  BPI  X  X  X  X  X  X  CES-D  X    X  X  X  X  Pain-free days  X  X  X  X  X  X  PGIC        X  X  X  Demographics  X            Medication use  X    X  X    X  Measure  Baseline  Pre 1  Week 1  Week 8  Week 12  Week 24  BPI  X  X  X  X  X  X  CES-D  X    X  X  X  X  Pain-free days  X  X  X  X  X  X  PGIC        X  X  X  Demographics  X            Medication use  X    X  X    X  BPI = Brief Pain Inventory–Short Form; CES-D = Center for Epidemiological Studies–Depression Scale; Pre = pre-acupuncture; Week 1 = first acupuncture visit. Analysis Pain severity was measured using four BPI questions related to worst, least, average, and current pain. Each question was scaled from 0 (no pain) to 10; the answers were summed to form the scale pain severity measure. The multiple baseline (pre-intervention) measures were averaged for a single baseline measure. Pain interference was measured using four BPI questions related to worst, least, average, and current pain. Each question was scaled from 0 (no pain) to 10, and these were summed to form the scale pain interference measure. The multiple baseline (pre-intervention) measures were averaged for a single baseline measure. For the BPI, we also measured percent change from baseline to 24 weeks to identify those with at least a 30% change over that period. Depression was measured as the sum of the 20 CES-D questions (scored 0–10). Sociodemographic factors and baseline health indicators were examined comparing those patients who completed the 24-week follow-up (N = 96) with those who initiated treatment but either withdrew from or were lost to follow-up (N = 9) using the Fisher exact test for proportion and t test to compare means. Patients who enrolled in the study but never initiated treatment were omitted entirely from the analysis (N = 8). To compare average pain severity, pain interference, and depression scores over time, repeated measures GLM were used applying a Greenhouse-Geisser correction when the spherocity assumption was violated by the data. Additionally, baseline and 24-week outcomes were compared using repeated measures t tests. Data were entered, coded, and analyzed in SPSS v. 24. As there were no statistically significant differences between the eight- and 12-week outcomes on any of the measures, we have presented the data as baseline, midpoint, and end point to maximize the number of patients included in the analysis. For subjects (N = 85) who had both eight- and 12-week data, we averaged the values for analysis. To compare self-reported past two-week pain medication use from baseline to eight weeks and baseline to 24-week post-treatment, we used Pearson’s chi-square test of proportions. Results We recruited a total of 113 participants for the trial, 96 of whom completed the 24-week protocol. Eight patients never initiated the study intervention. Of the remaining nine subjects, two patients withdrew, one patient moved away after three sessions, one had surgery and could not complete the study, and five could not be reached for the 24-week follow-up. Our average age was 54.4 years, and the ethnic makeup of our study sample was representative of the New York City population. There were no significant differences between study completers and noncompleters in any category, including pain severity or depression at baseline. The majority of our participants were insured, with 30.6% of those on Medicaid or Medicare. Outcome results below represent the 96 study participants who completed the 24-week term of the trial. Demographics for the two groups are presented in Table 2. Table 2 Study demographics     Completed (N = 96)  LTFU (N = 9)  P      No. (%)  No. (%)    Ethnicity  Hispanic  25 (26.0)  2 (22.2)  1.00    Non-Hispanic  70 (72.9)  7 (77.8)      Missing  1 (0.1)  0 (0.0)    Race  Asian  8 (8.3)  1 (11.1)  0.41    Black/African American  13 (13.5)  3 (33.3)      Other  18 (18.7)  1 (11.1)      White  53 (55.2)  4 (44.4)      Missing  4 (4.2)  0 (0.0)    Education  Did not graduate high school  2 (2.1)  0 (0.0)  0.62    High school graduate  6 (6.3)  1 (11.1)      Some college  16 (16.7)  2 (22.2)      College graduate or greater  71 (74.0)  6 (66.7)      Missing  1 (1.0)  0 (0.0)    Work status  Full time  56 (58.3)  6 (66.7)  0.37    Part time  9 (9.4)  0 (0.0)      Retired  17 (17.7)  0 (0.0)      Student  2 (2.1)  0 (0.0)      Disabled  4 (4.2)  1 (11.1)      Unemployed  5 (5.2)  1 (11.1)      Missing  3 (3.1)  1 (11.1)    Income  <$20,000  10 (10.4)  2 (22.2)  0.86    $20,000–$49,000  26 (27.0)  1(11.1)      $50,000+  45 (46.9)  5 (55.6)      Don’t know/refused/missing  15 (15.6)  1 (11.1)    Receiving routine medical care  Yes  85 (88.5)  9 (100.0)  0.59    No  11 (11.5)  0 (0.0)    Insurance type  Private  57 (59.4)  7 (77.8)  0.77    Fee-for-service  1 (1.0)  0 (0.0)      Medicaid  12 (12.5)  0 (0.0)      Medicare  17 (17.7)  2 (22.2)      N/A or missing  9 (9.4)  0 (0.0)    Disability  Yes  6 (6.3)  1 (11.1)  0.48    No  89 (92.7)  8 (88.9)      Missing  1 (1.0)  0 (0.0)      Mean (SD)  Mean (SD)    Age, years  54.0 (15.5)  44.7 (12.8)  0.09  Baseline pain severity  5.0 (1.7)  5.3 (2.0)  0.59  Baseline pain interference  3.7 (2.1)  4.7 (2.1)  0.13  Baseline 2-week pain-free days  1.5 (2.1)  1.7 (3.5)  0.75  Baseline depression  13.7 (9.0)  17.6 (12.2)  0.23      Completed (N = 96)  LTFU (N = 9)  P      No. (%)  No. (%)    Ethnicity  Hispanic  25 (26.0)  2 (22.2)  1.00    Non-Hispanic  70 (72.9)  7 (77.8)      Missing  1 (0.1)  0 (0.0)    Race  Asian  8 (8.3)  1 (11.1)  0.41    Black/African American  13 (13.5)  3 (33.3)      Other  18 (18.7)  1 (11.1)      White  53 (55.2)  4 (44.4)      Missing  4 (4.2)  0 (0.0)    Education  Did not graduate high school  2 (2.1)  0 (0.0)  0.62    High school graduate  6 (6.3)  1 (11.1)      Some college  16 (16.7)  2 (22.2)      College graduate or greater  71 (74.0)  6 (66.7)      Missing  1 (1.0)  0 (0.0)    Work status  Full time  56 (58.3)  6 (66.7)  0.37    Part time  9 (9.4)  0 (0.0)      Retired  17 (17.7)  0 (0.0)      Student  2 (2.1)  0 (0.0)      Disabled  4 (4.2)  1 (11.1)      Unemployed  5 (5.2)  1 (11.1)      Missing  3 (3.1)  1 (11.1)    Income  <$20,000  10 (10.4)  2 (22.2)  0.86    $20,000–$49,000  26 (27.0)  1(11.1)      $50,000+  45 (46.9)  5 (55.6)      Don’t know/refused/missing  15 (15.6)  1 (11.1)    Receiving routine medical care  Yes  85 (88.5)  9 (100.0)  0.59    No  11 (11.5)  0 (0.0)    Insurance type  Private  57 (59.4)  7 (77.8)  0.77    Fee-for-service  1 (1.0)  0 (0.0)      Medicaid  12 (12.5)  0 (0.0)      Medicare  17 (17.7)  2 (22.2)      N/A or missing  9 (9.4)  0 (0.0)    Disability  Yes  6 (6.3)  1 (11.1)  0.48    No  89 (92.7)  8 (88.9)      Missing  1 (1.0)  0 (0.0)      Mean (SD)  Mean (SD)    Age, years  54.0 (15.5)  44.7 (12.8)  0.09  Baseline pain severity  5.0 (1.7)  5.3 (2.0)  0.59  Baseline pain interference  3.7 (2.1)  4.7 (2.1)  0.13  Baseline 2-week pain-free days  1.5 (2.1)  1.7 (3.5)  0.75  Baseline depression  13.7 (9.0)  17.6 (12.2)  0.23  LTFU = Lost to Follow Up. We had complete data on a total of 95 subjects on pain severity, 94 on pain interference, and 95 on the depression outcome. Using the generally accepted definition of a clinically significant change in pain being a 30% decrease from baseline, we found a statistically and clinically significant decrease in both pain severity and pain interference in our study population. This difference not only persisted beyond the eight-week end-of-treatment time point, but continued to increase through the 24-week measure despite no additional treatment. Pain severity decreased from 4.92 (95% confidence interval [CI] = 4.58–5.26) at baseline to 2.72 (95% CI = 2.19–3.32; P < 0.01) at 24 weeks. Pain interference decreased from 3.59 (95% CI = 3.17–4.01) at baseline to 1.87 (95% CI = 1.38–2.37; P < 0.01) at 24 weeks. Fifty-five out of 95 patients (57.8%) showed at least a 30% reduction in pain severity, and 64 out of 94 patients (68.0%) showed at least a 30% reduction in pain interference. The average number of acupuncture sessions completed was 6.7. Changes in pain severity and pain interference are shown in Figures 1 and 2. Figure 1 View largeDownload slide Brief Pain Inventory–Short Form pain severity. BPI = Brief Pain Inventory–Short Form. Figure 1 View largeDownload slide Brief Pain Inventory–Short Form pain severity. BPI = Brief Pain Inventory–Short Form. Figure 2 View largeDownload slide Brief Pain Inventory–Short Form pain interference. BPI = Brief Pain Inventory–Short Form. Figure 2 View largeDownload slide Brief Pain Inventory–Short Form pain interference. BPI = Brief Pain Inventory–Short Form. The number of pain-free days in the past two weeks also increased significantly during the course of the study from 1.4 (95% CI = 1.0–1.8); P < 0.01) at baseline to 4.8 (95% CI = 3.7–5.8; P < 0.01) at 24 weeks. Change in pain-free days is shown in Figure 3. Figure 3 View largeDownload slide Pain-free days. Figure 3 View largeDownload slide Pain-free days. Figure 4 View largeDownload slide Center for Epidemiological Studies–Depression Scale results. CES-D = Center for Epidemiological Studies–Depression Scale. Figure 4 View largeDownload slide Center for Epidemiological Studies–Depression Scale results. CES-D = Center for Epidemiological Studies–Depression Scale. We also found a statistically and clinically significant decrease in depression from baseline to 24 weeks as measured by the CES-D. The mean score at baseline was 13.47 (95% CI = 11.67–15.27) as compared with 9.79 (95% CI = 7.61–11.97; P < 0.01) at 24 weeks. The clinical significance of this change is less clear than with the pain measure as a cutoff of 16 on the CES-D is usually used as a threshold indicating a risk for clinical depression. As with the pain measures, the benefit in depression was maintained through the 24-week end point despite the fact that no additional treatment was offered after week 8. Depression results are shown in Figure 4. The PGIC measure decreased over the study period though the change did not reach clinical significance. Regarding medication use, we found that the proportion of subjects taking any type of pain medication over the previous two weeks fell from 87% at baseline to 65% at the 24-week mark (P < 0.01). However, the self-reported data on this outcome were too inconsistent to allow for analysis of specific medication categories. There were no serious adverse effects reported in this study and only infrequent minor adverse effects such as needle site irritation and bleeding and tiredness after treatment. Discussion Pain is a primary symptom that prompts health care seeking including for care by acupuncturists. Low back and neck pain were the leading causes of disability in 2015 in most countries [6], and approximately 12% of the US population age 25 to 74 years has clinically defined osteoarthritis (OA) of some joint [56]. There is evidence that acupuncture is effective for chronic pain including headache [57] and migraine [58], temporomandibular disorders [59] shoulder pain [17,18], pain of the lower back and neck, and osteoarthritis of the knee [15,16,19–30,60,61]. A 2016 meta-analysis of acupuncture trials for neck, lower back and shoulder pain, knee OA pain, and headache/migraine show that relief persists for 50% to 90% of responders even at 12 months’ post-treatment [31]. These trials, however, are of acupuncture given in individual sessions. The cost and lack of universal insurance coverage for acupuncture creates a significant barrier to access to individual acupuncture for patients from underserved and low–socioeconomic status populations; offering acupuncture therapy in the group setting is a potential solution to this access problem. Depression and other mental health comorbidities often contribute to disability and reduced quality of life in patients with chronic pain. Although studies are ongoing regarding the impact of acupuncture on depression, a 2010 systematic review with meta-analysis found acupuncture’s benefit to be similar to that of antidepressant medications [62]. A 2012 systematic review found that acupuncture alone was comparable with antidepressants or psychotherapy alone in the treatment of depression [63], and a 2013 systematic review found a high level of evidence to support the use of acupuncture in treating major depressive disorders in pregnancy [64]. A large-scale 2013 trial found that acupuncture and counseling can provide long-term benefits for many patients with ongoing depression in primary care [61,65]. Acupuncture is also shown to improve quality of life in patients with depression [66]. Group acupuncture (also known as “community acupuncture”) sessions and clinics have increased in the United States and in other countries to meet the demand for care by those who cannot afford out-of-pocket fees associated with individual session care. By group acupuncture here, we mean treating patients in turn in a shared setting, primarily seated in chairs proximal to one another. Patients may or may not interact with one another, but can hear conversation between other patients or between other patients and the practitioner. Although there are no official statistics on the number of community/group acupuncture clinics, as of 2012 at least 200 such programs were operating around the country, and this number has certainly grown at this point [67]. Group acupuncture has been studied for feasibility and quality of patient experience [67–70] for knee OA [34,35,70], for cancer pain, for peripheral neuropathy and digestive symptoms [36], to relieve radiation-induced xerostomia [71], and for pain and peripheral neuropathy in HIV patients [37]. However, no large-scale effectiveness trials of group acupuncture for chronic pain have been published to date. In previous work, we found it feasible and effective to deliver individual acupuncture sessions in an underserved primary care setting [32,33]. In this study, we confirm that acupuncture therapy in a group setting is feasible and effective in a primary care clinic in New York City. We found a significant reduction of chronic pain and depression over eight weeks of treatment. Perhaps more importantly, we found that this benefit was sustained through 24 weeks with no additional intervention despite the fact that our treatment intervention was only eight weeks long as opposed to the 12- to 16-week duration more common in clinical trials. These findings clarify that acupuncture therapy customarily given in an individual setting can reduce chronic pain and depression in patients with chronic pain when given in a group setting as well. Group acupuncture may therefore be considered a safe and effective option for chronic pain patients. Although our patient sample in this study was not exclusively drawn from a low-income or underserved population, there is no reason to assume that the pain outcomes we demonstrated here would not apply to these populations, potentially addressing the access issue that impacts those of a lower socioeconomic status. Limitations Our trial used a quasi-experimental design and did not have a control group. While acupuncture has been shown to be effective for chronic pain and depression in controlled trials, because of the lack of control group, we cannot definitively say that the acupuncture therapy was the discrete cause of the benefit to subjects here, as opposed to the nonspecific treatment effects of care or of participating in a group research project. A more ideal design would randomize between group and individual acupuncture, and in fact our current Patient-Centered Outcome Research Institute (PCORI)–funded effort, the Acupuncture Approaches to Decrease Disparities in Pain Treatment (AADDOPT-2) trial, is taking this approach in a randomized study of 700 patients receiving acupuncture at community health centers in the Bronx, New York. A second limitation in the present study was the lack of an effective strategy for collecting data on medication use, which is another important outcome potentially impacted by acupuncture treatment. 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Journal

Pain MedicineOxford University Press

Published: Feb 1, 2018

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