Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    90
  • sponsor
    Johns Hopkins University
Updated on 22 October 2021
Accepts healthy volunteers

Summary

The proposed randomized control trial will evaluate auricular point acupressure (APA) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (CMP) outcomes.

This study will randomly assign participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). EMA will be used to assess momentary pain outcomes and APA adherence.

Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments.

Description

Chronic musculoskeletal pain (CMP) is the most common self-reported and clinically diagnosed pain condition in the US and costs up to $635 billion annually. Analgesics/opioids are the most common treatments utilized by patients with CMP, however, unnecessary opioid use has resulted in the current opioid epidemic. The Institute of Medicine recommended guidelines for non-pharmacologic, self-management strategies to manage pain. However, these guidelines have not been broadly implemented due to time constraints among healthcare providers, accessibility, patient's beliefs/motivations, and high cost/insurance coverage, especially among socioeconomically disadvantaged and vulnerable patients.

Auricular point acupressure (APA), a non-invasive procedure, provides acupuncture-like stimulations on ear points using small pellets instead of needles to self-manage pain. The investigator's interdisciplinary team has accumulated extensive evidence (11 clinical trials) supporting the efficacy of interventionist-administered APA to manage pain. The randomized clinical trial (RCT) comparing APA to sham APA demonstrated: (1) Significant rapid and sustained effect: APA resulted to 38% rapid pain relief among participants at three minutes post-APA; >44% pain relief and >28% improved physical function at follow-up after 4-weeks APA; (2) Reduced use of medications: After 4-weeks of APA, 60% of participants reported less use of pain medications; and (3) Significant impact on physiological measures: APA controls pain through blocking pro-inflammatory cytokines (IL-1, IL-2) and modulating nerve sensitivity. No adverse effects from APA were reported.

The investigator's long-term goal is to eliminate pain care disparities and reduce society's reliance on opioids to manage pain. Leveraging technology, the proposed study will help advance mAPA, a novel, easy-to-initiate, rapid, safe, and non-pharmacologic tool incorporated in a self-management plan to manage pain in real-world settings. The proposed intervention promises to provide important and timely information to advance a non-opioid and self-managed pain treatment.

Details
Condition Chronic Musculoskeletal Pain
Treatment Usual Care, Virtual Auricular Point Acupressure (APA), In-Person Training
Clinical Study IdentifierNCT05020470
SponsorJohns Hopkins University
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults 18 years of age or older
Receiving outpatient pain treatment for CMP condition (e.g., pain in the back, hip, knee, upper extremity, lower extremity, neck, pelvic, headache/migraine)
Chronic pain 4 on a scale of 0-10 point numerical pain, persisting for at least 3 months or has resulted in pain on at least half the days in the past 6 months

Exclusion Criteria

Disease that might confound therapeutic effects or explanation of outcomes, i.e., infection, malignant tumors, or autoimmune diseases
Severe ear skin issues
Use of some types of hearing aids (size may obstruct the placement of seeds)
Concurrent major psychiatric disorder (i.e., participant self-report)
Pregnant women will be excluded from the study based on the self-reported data
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