Clinical trial NCT02456727: Acupuncture Approaches for Chronic Pain
Official title: Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment - A Two Arm Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Osteoarthritis
Neck Pain
Back Pain
Keywords: Acupuncture
Group/Community Acupuncture
Individual Acupuncture
Chronic Pain
Underserved
Urban Primary Care
Osteoarthritis
Back Pain
Neck Pain
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
name: Mount Sinai Beth Israel Department of Integrated Medicine
name: Pacific College of Oriental Medicine
name: Patient-Centered Outcomes Research Institute
First posted: 2015-05-28
Enrollment: 779
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to participants from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach.

The primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for participants with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the participants' experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the participants' perspective.


Eligibility criteria: Inclusion Criteria:

* Referred by a primary care provider from one of our participating primary care health centers
* Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain
* Self-reported pain score of ≥4 for at least 3 months prior to program entry
* Able to provide consent for treatment and data collection in either English or Spanish

Exclusion Criteria:

* \< 21 years of age
* Chronic pain not documented OR self reported pain of ≥4 for less than 3 months.
* Currently taking oral or injectable anticoagulants.
* Lack of contact information OR unavailable for duration of entire treatment period (24 weeks)
* Inability to consent to treatment and data collection.
* Active psychosis
* Active substance abuse

Primary outcomes:
measure: Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
measure: Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)
timeFrame: Baseline, Week 12 (End of Treatment Window)
measure: Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)
timeFrame: Baseline, Week 12 (End of Treatment)
measure: Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)
timeFrame: Baseline, Week 24 (12 weeks after treatment window)
measure: Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)
timeFrame: Baseline, Week 24 (12 weeks after treatment window)
Secondary outcomes:
measure: Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)
timeFrame: Baseline, Week 12 (End of Treatment Window)
measure: Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)
timeFrame: Baseline, Week 12 (End of Treatment Window)
measure: Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)
timeFrame: Baseline, Week 24 (12 Weeks After Treatment Window)
measure: Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)
timeFrame: Baseline, Week 24 (12 Weeks After Treatment Window)
measure: Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)
timeFrame: Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)
timeFrame: Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)
measure: Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)
timeFrame: Week 12 (End of Treatment Window)
measure: Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)
timeFrame: Week 12 (End of Treatment Window)
measure: Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)
timeFrame: Week 24 (12 Weeks After Treatment Window
measure: Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)
timeFrame: Week 24 (12 Week After Treatment Window)
measure: Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
measure: Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)
timeFrame: Baseline, Week 12 (End of treatment window)
measure: Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)
timeFrame: Baseline, Week 12 (End of Treatment Window)
measure: Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)
timeFrame: Baseline, Week 24 (12 Weeks After Treatment Window)
measure: Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)
timeFrame: Baseline, Week 24 (12 Weeks After Treatment Window)
measure: Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)
timeFrame: Baseline, Week 12 (End of Treatment Window)
measure: Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)
timeFrame: Baseline, Week 12 (End of Treatment Window)
measure: Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)
timeFrame: Baseline, Week 24 (12 Weeks After Treatment Window)
measure: Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)
timeFrame: Baseline, Week 24 (12 Weeks After Treatment Window)
measure: Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)
timeFrame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
measure: Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model)
timeFrame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
measure: Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model)
timeFrame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
measure: Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)
timeFrame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
measure: Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)
timeFrame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Group
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: M. Diane McKee, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Beth Israel
name: Benjamin Kligler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKee MD, Nielsen A, Anderson B, Chuang E, Connolly M, Gao Q, Gil EN, Lechuga C, Kim M, Naqvi H, Kligler B. Individual vs. Group Delivery of Acupuncture Therapy for Chronic Musculoskeletal Pain in Urban Primary Care-a Randomized Trial. J Gen Intern Med. 2020 Apr;35(4):1227-1237. doi: 10.1007/s11606-019-05583-6. Epub 2020 Feb 19.