Acupuncture for Chronic Low Back Pain in Older Adults

NCT04982315 | Completed Results DMC

• 2 other identifiers: BackInActionUH3AT010739
• Study Type: interventional
• Target: 807
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-back Pain; Acupuncture Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Back-related Disability at 6-month Post Randomization (Continuous)

  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.

  Baseline to 6-month

Secondary Outcomes (7)

• Change in Back-related Disability at 3-, and 12-month (Continuous)

  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 Disability at 3-, 6-, and 12-months (Binary)

  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)

  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)

  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 Physical Functioning at 3-, 6- and 12-month (Continuous)

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

Other Outcomes (6)

• Change in Sleep Quality

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

• Change in Sleep Duration at 3-, 6- and 12-month

  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 Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous)

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

Study Arms (3)

Standard Acupuncture

EXPERIMENTAL

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

Procedure: Standard Acupuncture

Enhanced Acupuncture

EXPERIMENTAL

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

Procedure: Enhanced Acupuncture

Usual Care

NO INTERVENTION

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.

Interventions

Standard Acupuncture PROCEDURE

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.

Standard Acupuncture

Enhanced Acupuncture PROCEDURE

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.

Enhanced Acupuncture

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (4)

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Location

Sutter Health

Walnut Creek, California, 94596, United States

Location

Institute for Family Health

New York, New York, 10035, United States

Location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98103, United States

Location

Related Publications (4)

• DeBar LL, Wellman RD, Justice M, Avins AL, Beyrouty M, Eng CM, Herman PM, Nielsen A, Pressman A, Stone KL, Teets RY, Cook AJ. Acupuncture for Chronic Low Back Pain in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2531348. doi: 10.1001/jamanetworkopen.2025.31348.

  PMID: 40938602 DERIVED

• Justice M, Piccorelli A, Avins AL, Cook AJ, Eng CM, Nielsen A, Pressman A, Stone KL, Teets RY, Wellman R, DeBar LL. Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults. Contemp Clin Trials. 2025 Aug;155:107981. doi: 10.1016/j.cct.2025.107981. Epub 2025 Jun 6.

  PMID: 40484274 DERIVED

• Wang PZ, Pressman A, Sanchez G, Aparicio C, Nielsen A, Avins A. Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials. Integr Med Res. 2024 Jun;13(2):101042. doi: 10.1016/j.imr.2024.101042. Epub 2024 Apr 17.

  PMID: 38765784 DERIVED

• DeBar LL, Justice M, Avins AL, Cook A, Eng CM, Herman PM, Hsu C, Nielsen A, Pressman A, Stone KL, Teets RY, Wellman R. Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial. Contemp Clin Trials. 2023 May;128:107166. doi: 10.1016/j.cct.2023.107166. Epub 2023 Mar 27.

  PMID: 36990274 DERIVED

Limitations and Caveats

Limitations: UMC control group precludes assessment of attention or other nonspecific effects on outcomes; results may be affected by subjectivity in PROs; treatment impact on medication changes unattainable due to limited robust medication-dispensing data at 2 sites; even after imputation and non-response weighting, residual bias may remain, potentially due to differential loss to follow-up by arm; significant findings for secondary outcomes should be interpreted cautiously.

Results Point of Contact

• Title: Andrea Cook, PhD - Principal Investigator
• Organization: Kaiser Permanente Washington

andrea.j.cook@kp.org

206-287-4257

Study Officials

• Lynn L DeBar, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Andrea J Cook, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 29, 2021
• Study Start: August 12, 2021
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The de-identified dataset will be released within 12 months of the publication of the primary manuscript.
• Access Criteria: 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.

Locations

US (4)