AzTrials
AzTrials

Chronic PainAADDOPT-2NCT02456727

Acupuncture Approaches for Chronic Pain

A study testing Group/Community Acupuncture and Individual Acupuncture in people with Chronic Pain and Osteoarthritis, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Pain, Osteoarthritis, Neck Pain
What is being tested?
Group/Community Acupuncture and Individual Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
779 participants
Where
1 siteUnited States
Study dates
May 2015to Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Montefiore Medical Group

    The Bronx, New York, 10461

Other trials in United States

About this study

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

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.

Being tested
Group/Community Acupuncture, Individual Acupuncture
Keywords
Acupuncture, Group/Community Acupuncture, Individual Acupuncture, Chronic Pain, Underserved, Urban Primary Care, Osteoarthritis, Back Pain, Neck Pain
Medical subject headings
Chronic Pain, Osteoarthritis, Neck Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group/Community AcupunctureProcedure or surgery

    Acupuncture treatment in a group setting.

  • Individual AcupunctureProcedure or surgery

    Acupuncture treatment in an individual setting.

Study groups in NCT02456727
Study groupRoleWhat they receive
Individual AcupunctureActive comparatorParticipants 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.
Receives: Procedure: Individual Acupuncture
Group/Community AcupunctureActive comparatorParticipants 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.
Receives: Procedure: Group/Community Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: Baseline, Week 12 (End of Treatment Window)

  4. 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.

    Measured: Baseline, Week 12 (End of Treatment)

  5. 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.

    Measured: Baseline, Week 24 (12 weeks after treatment window)

  6. 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.

    Measured: Baseline, Week 24 (12 weeks after treatment window)

Secondary outcomes (32)
  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: Baseline, Week 12 (End of Treatment Window)

  4. 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.

    Measured: Baseline, Week 12 (End of Treatment Window)

  5. 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.

    Measured: Baseline, Week 24 (12 Weeks After Treatment Window)

  6. 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.

    Measured: Baseline, Week 24 (12 Weeks After Treatment Window)

  7. 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.

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

  8. 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.

    Measured: Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)

  9. 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.

    Measured: Week 12 (End of Treatment Window)

  10. 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.

    Measured: Week 12 (End of Treatment Window)

  11. 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.

    Measured: Week 24 (12 Weeks After Treatment Window

  12. 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.

    Measured: Week 24 (12 Week After Treatment Window)

  13. 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.

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

  14. 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..

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

  15. 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.

    Measured: Baseline, Week 12 (End of treatment window)

  16. 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.

    Measured: Baseline, Week 12 (End of Treatment Window)

  17. 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.

    Measured: Baseline, Week 24 (12 Weeks After Treatment Window)

  18. 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.

    Measured: Baseline, Week 24 (12 Weeks After Treatment Window)

  19. 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.

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

  20. 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.

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

  21. 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.

    Measured: Baseline, Week 12 (End of Treatment Window)

  22. 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.

    Measured: Baseline, Week 12 (End of Treatment Window)

  23. 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.

    Measured: Baseline, Week 24 (12 Weeks After Treatment Window)

  24. 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.

    Measured: Baseline, Week 24 (12 Weeks After Treatment Window)

  25. 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.

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

  26. 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.

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

  27. 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.

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

  28. 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.

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

  29. 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).

    Measured: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)

  30. 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).

    Measured: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)

  31. 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.

    Measured: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)

  32. 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.

    Measured: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
779 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02456727
Sponsor's protocol ID
2014-4192
Other IDs
AD-1402-10857
Acronym
AADDOPT-2
Status last verified
Aug 2020
First submitted
31 Mar 2015
Last updated
18 Sep 2020
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32076985

Questions about this trial

What is this clinical trial studying?

A study testing Group/Community Acupuncture and Individual Acupuncture in people with Chronic Pain and Osteoarthritis, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02456727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in