Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment - A Two Arm Comparative Effectiveness Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Albert Einstein College of Medicine
- Enrollment
- 779
- Locations
- 1
- Primary Endpoint
- Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Diane Mckee
Prof. Family and Social Medicine
Albert Einstein College of Medicine
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
Outcomes
Primary Outcomes
Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)
Time Frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
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.
Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)
Time Frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
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.
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)
Time Frame: Baseline, Week 12 (End of Treatment)
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.
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)
Time Frame: Baseline, Week 12 (End of Treatment Window)
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.
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)
Time Frame: Baseline, Week 24 (12 weeks after treatment window)
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.
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)
Time Frame: Baseline, Week 24 (12 weeks after treatment window)
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.
Secondary Outcomes
- Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)(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))
- Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)(Week 12 (end of treatment window), and week 24 (12 weeks after treatment window))
- 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))
- Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)(Week 12 (End of Treatment Window))
- Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)(Week 24 (12 Weeks After 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))
- Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) 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 (Per Protocol Model)(Baseline, Week 24 (12 Weeks After Treatment Window))
- Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)(Week 24 (12 Week After Treatment Window))
- Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)))
- Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)(Baseline, Week 12 (End of treatment window))
- Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)(Baseline, 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 as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)(Week 12 (End of Treatment Window))
- Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)(Baseline, Week 24 (12 Weeks After Treatment Window))
- Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)(6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment))
- Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- 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)(6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment))
- Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)(Baseline, Week 12 (End of Treatment Window))
- Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)(Baseline, Week 12 (End of Treatment Window))
- Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)(Baseline, Week 24 (12 Weeks After Treatment Window))
- Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)(Baseline, Week 24 (12 Weeks After Treatment Window))
- Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- 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)(6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment))
- Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)(Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
- Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)(6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment))