Chronic Low-back PainBackInActionNCT04982315

Acupuncture for Chronic Low Back Pain in Older Adults

A study testing Standard Acupuncture and Enhanced Acupuncture in people with Chronic Low-back Pain, run by Kaiser Permanente at 4 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Chronic Low-back Pain
What is being tested?: Standard Acupuncture and Enhanced Acupuncture
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 807 participants
Where: 4 sitesUnited States
Study dates: 12 Aug 2021to 7 Feb 2024
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Show all 9Show fewer

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)

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Institute for Family Health
New York, New York, 10035
Kaiser Permanente Division of Research
Oakland, California, 94612
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98103
Sutter Health
Walnut Creek, California, 94596

Other trials in United States

About this study

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

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.

Read the 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
Being tested: Standard Acupuncture, Enhanced Acupuncture
Keywords: Chronic Low-back Pain, Acupuncture Therapy

What participants receive

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

Standard AcupunctureProcedure or surgery
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.
Enhanced AcupunctureProcedure or surgery
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.

Study groups in NCT04982315
Study group	Role	What they receive
Standard Acupuncture	Experimental	Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Receives: Procedure: Standard Acupuncture
Enhanced Acupuncture	Experimental	Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Receives: 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.

What is being measured

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

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.
Measured: Baseline to 6-month

Secondary outcomes (7)

Change in Back-related Disability at 3-, and 12-month (Continuous)
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.
Measured: 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)
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.
Measured: 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.
Measured: 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. 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.
Measured: 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)
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.
Measured: 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 (PGIC) at 3-, 6-, and 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.
Measured: Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months
Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE)
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).
Measured: SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.

Timeline

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

12 Aug 20217 Feb 2024

First posted29 Jul 2021
Study start12 Aug 2021
Primary completion7 Feb 2024
Study completion7 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 807 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04982315
Sponsor's protocol ID: BackInAction
Other IDs: UH3AT010739
Acronym: BackInAction
Status last verified: Dec 2025
First submitted: 1 Jul 2021
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 40938602
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.
PubMed 40484274
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.
PubMed 38765784
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.
PubMed 36990274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
ClinicalTrials.gov ID: NCT04982315
Acronym / sponsor ID: BackInAction / BackInAction
Conditions: Chronic Low-back Pain
Keywords: Chronic Low-back Pain, Acupuncture Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 807 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 12 Aug 2021 (actual)
Primary completion: 7 Feb 2024 (actual)
Study completion: 7 Feb 2024 (actual)
First posted: 29 Jul 2021 (actual)
Results: Posted 6 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Standard Acupuncture	Experimental	Procedure: Standard AcupunctureParticipants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months.
Enhanced Acupuncture	Experimental	Procedure: Enhanced AcupunctureParticipants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months.
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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard AcupunctureThe 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 or surgery	Standard Acupuncture
Enhanced AcupunctureThe 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.	Procedure or surgery	Enhanced Acupuncture

Primary outcome

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

7 secondary outcomes

Change in Back-related Disability at 3-, and 12-month (Continuous)
Time frame: 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)
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, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous)
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
Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary)
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 Physical Functioning at 3-, 6- and 12-month (Continuous)
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
Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months
Time frame: Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months
Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE)
Time frame: SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.

Results and safety

Results posted to the registry on 6 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	266	237
Standard Acupuncture	265	260
Enhanced Acupuncture	269	256

Primary outcome: Change in Back-related Disability at 6-month Post Randomization (Continuous)

Time frame: Baseline to 6-month. Least squares mean (95% Confidence Interval). Unit: change in score from baseline on scale

Measure	Usual Care n = 266	Standard Acupuncture n = 265	Enhanced Acupuncture n = 269
Value	-2.1 (-2.7 to -1.5)	-3.1 (-3.7 to -2.5)	-3.6 (-4.3 to -3.0)

Usual Care vs Standard Acupuncture: Mean Difference (Final Values): -1.0 (95% CI -1.9 to -0.1), p = .024, Wald Test, 2-sided
Usual Care vs Enhanced Acupuncture: Mean Difference (Final Values): -1.5 (95% CI -2.5 to -0.6), p = .001, Wald Test, 2-sided
Standard Acupuncture vs Enhanced Acupuncture: Mean Difference (Final Values): -0.5 (95% CI -1.5 to 0.5), p = .286, Wald Test, 2-sided

Population analysed: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected during the one-year period of enrollment for each study participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	18 of 266 (6.8%)	0 of 266 (0%)	2 of 266
Standard Acupuncture	24 of 265 (9.1%)	24 of 265 (9.1%)	0 of 265
Enhanced Acupuncture	24 of 269 (8.9%)	27 of 269 (10%)	1 of 269

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40938602DeBar 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.
Derived from this study: PubMed 40484274Justice 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.
Derived from this study: PubMed 38765784Wang 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.
Derived from this study: PubMed 36990274DeBar 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lynn L DeBar, PhD, MPH principal investigator

Kaiser Permanente

Andrea J Cook, PhD principal investigator

Kaiser Permanente

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard Acupuncture and Enhanced Acupuncture in people with Chronic Low-back Pain, run by Kaiser Permanente at 4 sites 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 9 inclusion and 11 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 6 Jan 2026). 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?

Change in Back-related Disability at 6-month Post Randomization (Continuous) (time frame: Baseline to 6-month). 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 NCT04982315, which also lists 4 linked publications.

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 6 Jan 2026.