Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04982315
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : October 8, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Procedure: Standard Acupuncture Procedure: Enhanced Acupuncture Not Applicable

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 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 a total of 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Acupuncture
Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months.
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.

Experimental: Enhanced Acupuncture
Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months.
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.

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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 6-months would indicate greater improvement.

  2. Achieving Minimal Clinically Important Difference (MCID) in back-related dysfunction 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 ]
    The MCID is measured by a 30% improvement (reduction) on the RMDQ. Because the MCID reflects clinical improvement, this measure indicates what proportion of individuals in each study group improved at least 30% at each follow-up timepoint on the RMDQ.

  3. 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 ]
    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.

  4. 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 ]
    The MCID is measured by a 30% improvement (reduction) on the PEG. Because the MCID reflects clinical improvement, this measure indicates what proportion of individuals in each study group improved at least 30% for a particular follow-up timepoint on the PEG.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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. ]
    Serious Adverse Effects/non-Serious Adverse Effects attributed to acupuncture



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982315


Contacts
Layout table for location contacts
Contact: Morgan J Fuoco, MA 877-750-8159 Morgan.J.Fuoco@kp.org
Contact: Carolyn M Eng, PhD 877-750-8159 Carolyn.M.Eng@kp.org

Locations
Layout table for location information
United States, California
Kaiser Permanente Division of Research Recruiting
Oakland, California, United States, 94612
Contact: Andrew L Avins, MD, MPH    866-532-1897    backinaction@kp.org   
Principal Investigator: Andrew L Avins, MD, MPH         
Sutter Health Recruiting
Walnut Creek, California, United States, 94596
Contact: Heather Law    925-239-6726    lawh@sutterhealth.org   
Principal Investigator: Alice Pressman, PhD, MS         
United States, New York
Institute for Family Health Recruiting
New York, New York, United States, 10035
Contact: Matt Beyrouty    212-659-1406    Mbeyrouty@institute.org   
Principal Investigator: Raymond Teets, MD         
United States, Washington
Kaiser Permanente Washington Health Research Institute Recruiting
Seattle, Washington, United States, 98103
Contact: Morgan J Fuoco, MA    877-750-8159      
Contact: Carolyn M Eng, PhD    877-750-8159      
Principal Investigator: Lynn L DeBar, PhD, MPH         
Principal Investigator: Karen J Sherman, PhD, MPH         
Sponsors and Collaborators
Kaiser Permanente
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Layout table for investigator information
Principal Investigator: Lynn L DeBar, PhD, MPH Kaiser Permanente
Principal Investigator: Karen J Sherman, PhD, MPH Kaiser Permanente
Layout table for additonal information
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT04982315    
Other Study ID Numbers: BackInAction
UH3AT010739 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: 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.
URL: https://heal.nih.gov/about/public-access-data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
Chronic Low-back Pain
Acupuncture Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations