N/A
N=800
Acupuncture for Chronic Low Back Pain in Older Adults
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04982315 ↗Enrolled (actual)
800
Serious AEs
8.3%
Results posted
Jan 2026
Primary outcome: Primary: Change in Back-related Disability at 6-month Post Randomization (Continuous) — -2.1; -3.1; -3.6 change in score from baseline on scale — p=.024
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Acupuncture (Procedure); Enhanced Acupuncture (Procedure)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Kaiser Permanente
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Back-related Disability at 6-month Post Randomization (Continuous) |
-2.1; -3.1; -3.6 | .024 sig |
| SECONDARY Change in Back-related Disability at 3-, and 12-month (Continuous) |
-2.0; -3.4; -3.4; -1.8; -3.0; -3.5 | — |
| SECONDARY Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) |
29.9; 42.0; 42.0; 29.4; 39.1; 43.8 | <.001 sig |
| SECONDARY Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) |
-0.6; -1.4; -1.4; -0.6; -1.1; -1.5 | — |
| SECONDARY Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) |
23.3; 41.1; 41.1; 29.4; 35.0; 40.5 | — |
| SECONDARY Change in Physical Functioning at 3-, 6- and 12-month (Continuous) |
0.8; 1.6; 1.6; 1.0; 1.2; 1.8 | .025 sig |
| SECONDARY Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months |
3.4; 4.5; 4.5; 3.3; 4.0; 4.6 | — |
| SECONDARY Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) |
18; 24; 24; 0; 24; 27 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04982315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.