Clinical trial NCT04982315: Acupuncture for Chronic Low Back Pain in Older Adults
Official title: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low-back Pain
Acupuncture Therapy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-07-29
Enrollment: 807
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in back-related disability at 6-month post randomization (continuous)
timeFrame: Baseline to 6-month
Secondary outcomes:
measure: Change in back-related disability at 3-, and 12-month (continuous)
timeFrame: Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Achieving Minimal Clinically Important Difference (MCID) in back-related dysfunction at 3-, 6-, and 12-months (binary)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Change in Pain, Pain Interference with Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (continuous)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Achieving MCID in Pain, Pain Interference with Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (binary)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Change in physical functioning at 3-, 6- and 12-month (continuous)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Patient global impression of change (PGIC) at 3-, 6-, and 12- months
timeFrame: Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months
measure: Serious Adverse Effects (SAE)/non-Serious Adverse Effects (AE)
timeFrame: SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.
Other outcomes:
measure: Change in sleep duration at 3-, 6- and 12-month and in sleep during at 6-months (continuous)
timeFrame: 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)
measure: Change in symptoms suggesting clinically relevant anxiety at 3-, 6- and 12-month (continuous)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Change in symptoms suggesting depression at 3-, 6- and 12-month (continuous)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Change in fatigue at 3-, 6- and 12-month (continuous)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Change in ability to engage in social roles at 3-, 6- and 12-month (continuous)
timeFrame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
measure: Cost and incremental cost-effectiveness
timeFrame: 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
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: Walnut Creek
country: United States
facility: Sutter Health
state: California
city: New York
country: United States
facility: Institute for Family Health
state: New York
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Lynn L DeBar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Andrea J Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: