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

Johns Hopkins University

Status: Completed

Conditions: Chronic Musculoskeletal Pain

Treatments: Other: In-Person Training; Other: Usual Care; Device: Virtual Auricular Point Acupressure (APA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05020470

IRB00290512

Details and patient eligibility

About

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.

Full 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-1β, 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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37 participants in 3 patient groups

Self-guided mAPA (S-mAPA)

Experimental group

Description:

S-mAPA group will be provided with instructions so that participants can learn to self-administer APA weekly for four weeks and then followed by weekly telecommunication for Q \& As.

Treatment:

Device: Virtual Auricular Point Acupressure (APA)

In-Person Training + mAPA (IP-mAPA)

Experimental group

Description:

Participants will receive one in-person training after baseline data is collected and then will self-administer APA on the same schedule with weekly telecommunication as those in the mAPA group.

Treatment:

Other: In-Person Training

Device: Virtual Auricular Point Acupressure (APA)

Usual Care Control (UC)

Active Comparator group

Description:

Participants will receive usual care only for their pain; after enrolled, patients will receive weekly telecommunication to control for attention and time. The content of the phone/video call will focus on the pain problem they have and the investigators will provide additional information published by the National Center for Complementary and Integrative Health "Chronic Pain: In-Depth" (https://www.nccih.nih.gov/health/chronic-pain-in-depth) which the investigators used in the R01 study for participants enrolled in the control group

Treatment:

Other: Usual Care