Self-Administered Acupressure for Veterans With Chronic Back Pain

NCT05423145 | Completed

• 2 other identifiers: IIR 20-2421I01HX003302-01A2
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Acupressure, a Traditional Chinese Medicine technique derived from acupuncture, is emerging as a potentially effective approach for treating several chronic pain conditions and could prove beneficial in helping Veterans manage their chronic low back pain. This study will determine the effectiveness of self-administered acupressure to treat chronic low back pain. 300 Veterans will be invited to participate in the study. All participants will be asked to attend an introduction to acupressure class and complete a survey when they join the study and again at 6 weeks and 10 weeks. The survey measures assess important outcomes, such as how pain interferes with daily function, as well as other areas that can be affected by pain such as fatigue and sleep quality. After completing the first survey, half of the participants will receive a tablet computer with an app that shows them how to self-administer acupressure for low back pain and will be asked to do daily acupressure sessions for the next 6 weeks. The other half of the participants will receive the tablet computer with the app approximately 10 weeks after completing the final survey based assessment. The investigators anticipate that outcomes will be improved after 6 weeks of acupressure practice, and these improvements will persist for the following 4 weeks.

Conditions

Low Back Pain

Keywords

acupressure; complementary therapies

Outcome Measures

Primary Outcomes (1)

• change in PROMIS 6b pain interference scale

  The Pain Interference Scale provides an assessment of the impact of pain on several aspects of functioning, including social and emotional processes as well as physical function (e.g., how much did pain interfere with your day to day activities) based on 6 items rated on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing greater interference (worse function). PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 60 represents a score that is 1 standard deviation above the US national average, and a 40 represents a score that is 1 standard deviation below the national average.

  baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)

Secondary Outcomes (3)

• change in PROMIS 8a fatigue scale

  baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)

• change in PROMIS 8b sleep disturbance scale

  baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)

• change in Roland Morris Disability scale

  baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)

Study Arms (2)

acupressure intervention

EXPERIMENTAL

Receives access to the acupressure intervention

Behavioral: self-administered acupressure

wait list control

NO INTERVENTION

No access to the acupressure intervention during the study period

Interventions

self-administered acupressure BEHAVIORAL

The acupressure intervention is self-administered. The intervention group receives an app that instructs them on how to perform a stimulating acupressure protocol, consisting of six acupoints with four of the acupoints performed on both the left and the right sides of the body for a total of ten points. Each of the ten acupoints is to be stimulated for 3 minutes per point for a total treatment time of 30 minutes daily for 6 weeks.

acupressure intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans enrolled at VA Ann Arbor Healthcare System
• non-specific low back pain confirmed through electronic medical records (i.e., ICD-10 codes: M54.5, M54.40, 41, 42, M54.89)
• reported pain severity of 4/10 that has persisted for at least 3 months and present on most days
• medically stable (no hospitalizations in the past month lasting 3 or more days)
• no changes in pain medication regimen in past 4 weeks
• no planned surgery or injections for back pain during the next 10 weeks

You may not qualify if:

• pregnant
• had back surgery in the past 2 years
• received acupuncture or acupressure in past 3 months
• evidence of cognitive impairment that could interfere with the ability to provide consent and follow the study protocol (defined as a score of 3 using the Callahan et al. 6-item screener)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Related Publications (1)

• Murphy SL, Zick SM, Harris RE, Smith SN, Sen A, Alexander NB, Caldararo J, Roman P, Firsht E, Belancourt P, Maciasz R, Perzhinsky J, Mitchinson A, Krein SL. Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial. Contemp Clin Trials. 2023 Jul;130:107232. doi: 10.1016/j.cct.2023.107232. Epub 2023 May 18.

  PMID: 37207810 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah L. Krein, PhD RN

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and analyst conducting the main analysis will be masked. The participants and project staff will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: two groups, intervention and wait list control

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: October 3, 2022
• Primary Completion: March 2, 2026
• Study Completion: March 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)