Acupuncture Approaches for Chronic Pain

Chronic Pain Clinical Trial

— AADDOPT-2  

Official title:

Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment - A Two Arm Comparative Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456727
• Other study ID #: 2014-4192
• Secondary ID: AD-1402-10857
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2018

Study information

• Verified date: August 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 779
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Neck Pain
• Osteoarthritis

Intervention

Procedure:
• Group/Community Acupuncture
Acupuncture treatment in a group setting.
• Individual Acupuncture
Acupuncture treatment in an individual setting.

Locations

Country	Name	City	State
United States	Montefiore Medical Group	Bronx	New York

Sponsors (5)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Montefiore Medical Center, Mount Sinai Beth Israel Department of Integrated Medicine, Pacific College of Oriental Medicine, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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))
Primary	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)
Primary	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)
Primary	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)
Primary	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	Pain Severity 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 measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and then divided by 4, 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 severity from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is anyone who intended to receive treatment; in our case, it 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)
Secondary	Pain Severity 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 measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, 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 severity 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)
Secondary	Improvement in Pain Severity 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 measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity 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 in pain severity 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)
Secondary	Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)	The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity 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 in pain severity is considered a clinically significant improvement in pain. The definition of 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 Window)
Secondary	Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)	The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity 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). A 30% decrease in pain severity 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 24 questionnaire were analyzed.	Baseline, Week 24 (12 Weeks After Treatment Window)
Secondary	Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)	The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity 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). A 30% decrease in pain severity is considered a clinically significant improvement in pain. 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 analyzed.	Baseline, Week 24 (12 Weeks After Treatment Window)
Secondary	Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)	The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. 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.	Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Secondary	Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)	The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. 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.	Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)
Secondary	Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)	The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.	Week 12 (End of Treatment Window)
Secondary	Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)	The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were included in the analysis.	Week 12 (End of Treatment Window)
Secondary	Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)	The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. 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.	Week 24 (12 Weeks After Treatment Window
Secondary	Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)	The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.	Week 24 (12 Week After Treatment Window)
Secondary	Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores 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))
Secondary	Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores 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)
Secondary	Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who have been randomized into treatment. Only patients who completed a week 12 questionnaire were included in the analysis.	Baseline, Week 12 (End of treatment window)
Secondary	Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=2-point increase is considered a 30% improvement. 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 12 questionnaire were included in the analysis.	Baseline, Week 12 (End of Treatment Window)
Secondary	Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a >=2-point increase is considered a 30% improvement. 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)
Secondary	Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as a >= 2-point increase in the PROMIS-10 T-score 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. Only participants who completed a week 24 questionnaire were included in the analysis.	Baseline, Week 24 (12 Weeks After Treatment Window)
Secondary	Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores 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)
Secondary	Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores 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)
Secondary	Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.	Baseline, Week 12 (End of Treatment Window)
Secondary	Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=5-point increase is what we used to measure improvement. 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 12 questionnaire were included in the analysis.	Baseline, Week 12 (End of Treatment Window)
Secondary	Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a >=5-point increase is what we used to measure improvement. 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)
Secondary	Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)	The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a >=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.	Baseline, Week 24 (12 Weeks After Treatment Window)
Secondary	Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)	Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of intent to treat is all participants who have been randomized into treatment. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. 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)
Secondary	Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)	Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of Per Protocol is all participants who have been randomized and who attended >=8 sessions of acupuncture. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. 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)
Secondary	Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)	Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication 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)
Secondary	Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)	Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication 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)
Secondary	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)	Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME for participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months prior and post-treatment). A smaller MME indicates that the participant was using less medication. The definition of intent to treat is all participants who were randomized into treatment. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).	6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Secondary	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)	Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME of participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months pre- and 3 months post-treatment). A smaller MME indicates that the participant was using less medication. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).	6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Secondary	Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)	Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 months post-treatment). The definition of intent to treat is all participants who were randomized into treatment. There were 191 total participants that had "any documented opioid prescriptions in EMR.	6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Secondary	Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)	Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 month post-treatment). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture.	6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)