NCT04982315

Acupuncture for Chronic Low Back Pain in Older Adults

Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 807 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
PROCEDURE	Standard Acupuncture	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.
PROCEDURE	Enhanced Acupuncture	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.

Timeline

• Start date: 2021-08-12
• Primary completion: 2024-02-07
• Completion: 2024-02-07
• First posted: 2021-07-29
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

4 sites across 1 country: United States