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Acupuncture for Chronic Pain in the Vermont Medicaid Population: A Prospective, Pragmatic Intervention Trial.

ABSTRACT: In response to the opioid crisis, the 2016 Vermont legislature commissioned a study to assess acupuncture for patients with chronic pain in the Vermont Medicaid population.To assess the feasibility, acceptability, and effectiveness of acupuncture provided by licensed acupuncturists for Vermont Medicaid patients with chronic pain.A total of 156 Medicaid patients with chronic pain were offered up to 12 acupuncture treatments within a 60-day period at the offices of 28 Vermont licensed acupuncturists. PROMIS® questionnaires were administered prior to and at the end of the treatment period to assess changes in pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation. Questionnaires also captured patients' overall impressions of treatments as well as self-reported changes in medication use and work function.One hundred eleven women (71%) and 45 men (29%) with a wide range of pain complaints received a mean of 8.2 treatments during the intervention period. Measurements captured prior to and at the end of the treatment period showed significant improvements in group mean pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) measures (paired t tests, P < .01). Fifty-seven percent of patients using analgesic (nonopioid) medication reported reductions in use. Thirty-two percent of patients using opioid medication reported reductions in use of opioid medication following the intervention. Seventy-four percent of employed patients reported improved capacity to work. Ninety-six percent of patients said that they would recommend acupuncture to others with chronic pain, and 91% reported qualitative improvements, including physical (31%), functional/behavioral (29%), and psycho-emotional (24%) improvements.Our findings demonstrate that acupuncture treatment for chronic pain is feasible and well received by patients in the Vermont Medicaid population. Receiving care from Licensed Acupuncturists was associated with significant improvements in physical, functional, psycho-emotional, and occupational outcomes compared with before receiving acupuncture treatments.

SUBMITTER: Davis RT

PROVIDER: S-EPMC5896847 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Acupuncture for Chronic Pain in the Vermont Medicaid Population: A Prospective, Pragmatic Intervention Trial.

Davis Robert T RT Badger Gary G Valentine Kristina K Cavert Alexander A Coeytaux Remy R RR

Global advances in health and medicine 20180410

<h4>Introduction</h4>In response to the opioid crisis, the 2016 Vermont legislature commissioned a study to assess acupuncture for patients with chronic pain in the Vermont Medicaid population.<h4>Objective</h4>To assess the feasibility, acceptability, and effectiveness of acupuncture provided by licensed acupuncturists for Vermont Medicaid patients with chronic pain.<h4>Methods</h4>A total of 156 Medicaid patients with chronic pain were offered up to 12 acupuncture treatments within a 60-day pe ...[more]

PMID: 29662722

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Project description:IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023.

Project description:BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.

Project description:BACKGROUND:Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS:A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS:At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS:Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Project description:BackgroundChronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.ObjectiveTo determine the effectiveness of a group-based CBT intervention for chronic pain.DesignPragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).SettingKaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.ParticipantsAdults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.InterventionA CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.MeasurementsSelf-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.ResultsA total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.LimitationThe inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.ConclusionPrimary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.Primary funding sourceNational Institutes of Health.

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Acupuncture for Chronic Pain in the Vermont Medicaid Population: A Prospective, Pragmatic Intervention Trial.

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Acupuncture for Chronic Pain in the Vermont Medicaid Population: A Prospective, Pragmatic Intervention Trial.

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