NCT Number: NCT04982315
The main goal of the BackInAction research study is to determine the effectiveness of a standard course of acupuncture (15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults (65+ years) with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Kaiser Permanente Division of Research, Oakland, California, United States
Background: A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults (65+ years) with chronic low back pain. Acupuncture has been found to be effective in treating chronic low back pain in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. BackInAction has been designed to address this gap.
Purpose: The main goal of BackInAction is to evaluate the effectiveness of a standard course of acupuncture (up to 15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (up to an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
Design and Outcomes: In this pragmatic, three-arm parallel groups multi-site randomized controlled trial, the investigators will recruit and randomize at least 789 adults ≥ 65 years of age with chronic low back to standard acupuncture, enhanced acupuncture, or usual medical care alone in four health-care systems. These include two integrated health care systems, a fee-for-service system and a network of federally qualified health centers. Primary outcome data will be collected by questionnaire at 3-, 6-, and 12-months post-randomization. In addition, short monthly surveys will capture data on physical function and a composite score of pain intensity and pain interference.
Interventions and Duration: Standard acupuncture will consist of 3 months (90 days) of acupuncture needling, with a proposed minimum of 8 treatments and a maximum of 15. Enhanced acupuncture will include the standard acupuncture plus an additional 3-month maintenance period, with a maximum of six additional treatments. Usual medical care will consist of the care that individuals receive according to their insurance benefits plus anything else they pay for out of pocket. The investigators will ask those assigned to usual medical care to avoid acupuncture for the year they are enrolled in the study. Both active treatment arms will also have access to usual medical care. Participants will be enrolled in the study for 12 months.
Sample Size and Population: BackInAction will include patients at least 65 years of age with uncomplicated chronic low back pain with or without radiculopathy. The investigators plan to enroll at least 789 participants (263 per study arm). Participants will be recruited from four health plans, with varying numbers of participants from each site. Randomization will be stratified by health care system, age category and gender. The investigators expect the racial and ethnic mix will roughly parallel that of the older Medicare population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
Time frame: Baseline to 6-month
Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement.
Time frame: Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in back-related disability is defined as score change in RMDQ, a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 3-months or 12-months would indicate greater improvement.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
The MCID is measured by a 30% improvement (reduction) on the Roland Morris Disability Questionnaire Revised (RMDQ-R). The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in pain intensity and pain interference with enjoyment of life and general activity will be measured by PEG, a 3-item pain-intensity and pain-related interference composite measure assessing pain intensity, and pain interference with enjoyment of life and general activity. Each item is measured by a 0 to 10 scale with 10 indicating greater pain intensity or pain interference. The scores are then averaged with a higher average score indicating greater pain interference/intensity.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
The MCID is measured by a 30% improvement (reduction) on the PEG. The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in the Patient-Reported Outcomes Measurement and Information System (PROMIS) Physical functioning short form 6b from the PROMIS-29 (6 items). The 6-item Physical function scale measures self-reported ability to perform activities rather than the actual performance of those activities. Each question has five response options, ranging from one to five. Raw scores range from 6 to 30, with higher scores indicating greater ability. The scores are then standardized using a T-score metric in which 50 is the reference mean and 10 is the standard deviation (SD) of that population.
Time frame: Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months
Patient Global Impression of Change in Overall Pain (1 item). This is a 0 to 6 scale ranging from much worse to much better, with higher scores indicating more improvement.
Time frame: SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.
Serious adverse events were defined as hospitalizations and deaths. Only potentially treatment-related non-serious adverse events were reported in the acupuncture arms (not usual care).
Time frame: Study primary outcome timepoint: Baseline to 6 months (sleep quality)
Change in sleep quality is measured by the six-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Sleep Disturbance Short Form 6a. The raw computed score has a range of 6-30 with higher scores indicating more sleep disturbance. The raw score is converted to a T-score with mean of 50, standard deviation of 10. Higher T-scores indicate worse sleep quality. PROMIS Sleep Scoring Manual. Published online June 3, 2022. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Sleep_Scoring_Manual_03June2022.pdf
Time frame: Study primary outcome timepoint: Baseline to 6 months (sleep duration); Test of Standard Acupuncture: Baseline to 3 months (sleep duration only); Test of Maintenance effect: Baseline to 12 months (sleep duration only)
Change in 1-item sleep duration scale for sleep duration.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in PRO scores about the frequency of being anxious or having uncontrollable worry over the past two weeks from the GAD-2, which is part of the PHQ-4. Each item is measured by a 0 to 3 scale with 3 indicating greater anxiety. GAD-2 range is 0-6, with 6 being greater anxiety symptoms.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in PRO scores about the frequency of depressed mood and anhedonia over the past two weeks from the PHQ-2. Each item is measured by a 0 to 3 scale with 3 indicating greater depression. Total score is 0-6, with 6 indicating greater depression.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in fatigue will be measured by a change in T-score of the 4-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Fatigue Subscale - SF 4a. This PROMIS measure has a T-score with a mean of 50 and a standard deviation of 10, meaning a score of 50 is average. Higher T-scores indicates greater fatigue. PROMIS Fatigue Scoring Manual. Published online November 4, 2016. https://www.fda.gov/media/137977/download
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Change in ability to engage in social roles will be measured by the 4-item subscale for ability to participate in social roles in PROMIS. PROMIS measures are standard T-score range of 20-80, with higher scores indicating greater ability to engage in social roles.
Kaiser Permanente
Other
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
Acronym: BackInAction
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