Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)

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.

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.

Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months.

Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months.

Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.

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.

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.

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 6-months would indicate greater improvement.

Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Achieving Minimal Clinically Important Difference (MCID) in back-related dysfunction at 3-, 6-, and 12-months (binary)

The MCID is measured by a 30% improvement (reduction) on the RMDQ. Because the MCID reflects clinical improvement, this measure indicates what proportion of individuals in each study group improved at least 30% at each follow-up timepoint on the RMDQ.

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, Pain Interference with Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (continuous)

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.

Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Achieving MCID in Pain, Pain Interference with Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (binary)

The MCID is measured by a 30% improvement (reduction) on the PEG. Because the MCID reflects clinical improvement, this measure indicates what proportion of individuals in each study group improved at least 30% for a particular follow-up timepoint on the PEG.

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.

Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 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.

Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months

SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.

Change in sleep quality will be measured by the 6-item subscale for sleep quality in the Patient-Reported Outcomes Measurement and Information System (PROMIS) and a 1-item sleep duration scale for sleep duration. For sleep quality, each item is measured by a 1 to 5 scale with 1 indicating greater sleep quality.

Study primary outcome timepoint: Baseline to 6 months (sleep quality and 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 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.

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.

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 the 4-item subscale for fatigue in PROMIS. Each item is measured by a 1 to 5 scale with 5 indicating greater fatigue.

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. Each item is measured by a 1 to 5 scale with 5 indicating greater ability to engage in social roles.

Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Health care utilization and intervention costs will be assessed. Our primary measure of effectiveness (utility) at 12 months will be quality-adjusted life years (QALYs) gained measured by the EQ-5D-5L. We will also estimate the incremental cost per additional patient with a MCID (30% from baseline) reduction in the RMDQ at 12 months. The RMDQ is scored from 0 to 24, with higher scores indicating more disability.

Patient health care utilization costs from baseline to 12 months net of their utilization from the previous 12 months. EQ-5D-5L: Patient self-report at baseline, 3-, 6- and 12-months

Inclusion Criteria: Is at least 65 years of age Is a current member or patient of the healthcare system Visited a health care provider for low back pain within the past 12 months Received primary care at one of the participating health care systems Has back pain that is uncomplicated with or without radicular pain Back pain at least 3 months General activity question from PEG (Pain, Pain Interference with Enjoyment, General Activity scale) at least 3 Primary care provider provides permission to contact patient Willing and able to provide consent (Callahan cognitive impairment screener at least 3) Exclusion Criteria: Specific types of back pain (metastatic cancer or bone cancer or secondary cancers, vertebral fractures, spinal infection, active inflammatory disease) Low back surgery within past 3 months Receiving workers compensation or involved in litigation related to chronic low back pain Acupuncture within the last 6 months Does not speak or write English or Spanish Major psychosis, dementia Current cancer treatment Red flags of serious underlying illness (a fever most days in the last month; recent unexplained weight loss of 10 lbs or more) Living in a nursing home, on Hospice, or palliative care Non-speaking deafness Non-reliable transportation

The Kaiser Permanente Washington-based data coordinating center will produce a releasable de-identified database corresponding to the primary outcomes manuscript that can be used by research investigators outside of the study. This dataset will also include the NIH HEAL (Helping to End Addiction Long-term) Initiative common data elements collected from study participants. The dataset will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act and in accordance to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects. All identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional or healthcare system identifiers.

The de-identified dataset will be released within 12 months of the publication of the primary manuscript.

Access to the de-identified database housed in an NIH-assigned repository will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NCCIH). The project team does not plan to provide any support for investigators using the HEAL releasable database.