Acupuncture Approaches for Chronic Pain

NCT02456727 | Completed Results

• 2 other identifiers: 2014-4192AD-1402-10857
• Study Type: interventional
• Target: 779
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)

  The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much the participants' pain interferes with daily life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Investigators measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.

  Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)

• Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)

  The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.

  Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))

• Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)

  The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in their pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.

  Baseline, Week 12 (End of Treatment Window)

• Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)

  The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.

  Baseline, Week 12 (End of Treatment)

• Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)

  The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.

  Baseline, Week 24 (12 weeks after treatment window)

• Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)

  The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment). The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were included in the analysis.

  Baseline, Week 24 (12 weeks after treatment window)

Secondary Outcomes (32)

• Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)

  Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)

• Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)

  Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)

• Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)

  Baseline, Week 12 (End of Treatment Window)

• Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)

  Baseline, Week 12 (End of Treatment Window)

• Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)

  Baseline, Week 24 (12 Weeks After Treatment Window)

Study Arms (2)

Individual Acupuncture

ACTIVE COMPARATOR

Participants will be treated weekly with individual acupuncture treatment sessions for 12 consecutive weeks. Quality of life assessments will be taken at intervals during treatment and post-treatment.

Procedure: Individual Acupuncture

Group/Community Acupuncture

ACTIVE COMPARATOR

Participants will be treated weekly with group acupuncture treatments sessions for 12 consecutive weeks. Quality of life assessments will be taken at intervals during treatment and post-treatment.

Procedure: Group/Community Acupuncture

Interventions

Group/Community Acupuncture PROCEDURE

Acupuncture treatment in a group setting.

Group/Community Acupuncture

Individual Acupuncture PROCEDURE

Acupuncture treatment in an individual setting.

Individual Acupuncture

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Montefiore Medical Center: collaborator
• Mount Sinai Beth Israel Department of Integrated Medicine: collaborator
• Pacific College of Oriental Medicine: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Montefiore Medical Group

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• 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.

  PMID: 32076985 DERIVED

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis; Neck Pain; Back Pain

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Results Point of Contact

• Title: Diane McKee
• Organization: Albert Einstein College of Medicine

Diane.Mckee@einstein.yu.edu

718-430-2952

Study Officials

• M. Diane McKee, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Benjamin Kligler, MD

  Mount Sinai Beth Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Family and Social Medicine

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: May 28, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 18, 2020
• Results First Posted: September 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)