Evaluating the Auricular Point Acupressure-Self Management Program for Chronic Musculoskeletal Pain Among Rural Populations

The University of Texas System (UT)

Status: Enrolling

Conditions: Chronic Knee Pain; Chronic Pain Management; Chronic Pain (Back / Neck); Joint Pain

Treatments: Behavioral: Education Control; Behavioral: Auricular Point Acupressure (APA) - Self Management (SM)

Study type: Interventional

Funder types: Other

Identifiers

NCT07179016

HSC-SN-25-0443

Details and patient eligibility

About

The investigators will test an Auricular Point Acupressure Self-Management (APA-SM) program integrated into rural primary and specialty care and rural communities for chronic musculoskeletal pain (CMP). To maximize self-management of pain, the investigators developed a smartphone app which will allow the participants to learn to self-administer APA. The investigators will have 3 arms (APA-SM self-guided with remote training, APA-SM with in-person training, and Education Control) with 231 participants per arm (total=693 for 3 arms). The investigators will evaluate the clinical effectiveness of our 4-week APA-SM intervention compared to control in primary outcomes (pain intensity, pain interference, activity), secondary outcomes (HEAL Clinical Pain Core common data elements), and analgesic use up to 6 months follow-up.

Full description

The investigators integrated ecological momentary assessment into our app to measure real-world outcomes resulting in participants being able to self-monitor their progress, using this as an innovative behavior change strategy based on Bandura's self-efficacy, successfully initiating and maintaining behavior change. The primary endpoint will be immediate post-intervention with secondary endpoints at 1-month, 3-month, and 6-month follow-ups after the intervention. The investigators will also evaluate implementation outcomes and cost-effectiveness. Our long-term goal is to increase the access and scalability of evidence-based interventions while addressing pain care disparities for rural individuals with limited resources and/or endure long distances to specialty pain care. Study recruitment will be 3 1/2 to 4 years followed by data analysis.

Enrollment: 693 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receive any pain management for CMP (neck, back, shoulder, hands, hips, knees, feet)
• Have CMP ≥ 4 on a scale of 0-10 that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months

Exclusion criteria

• Severe ear skin disorder (Diagnosed with conditions e.g., eczema, lupus with skin involvement) which often require medical intervention and severe allergy to tape
• Inability or unwillingness to provide informed consent
• Use of some type of hearing aid where size may obstruct seed placement
• Not living in rural area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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693 participants in 3 patient groups

Remote APA-SM Training

Experimental group

Description:

APA-SM self-guided with remote training

Treatment:

Behavioral: Auricular Point Acupressure (APA) - Self Management (SM)

In-person APA-SM Training

Experimental group

Description:

APA-SM with in-person training

Treatment:

Behavioral: Auricular Point Acupressure (APA) - Self Management (SM)

Pain Education

Active Comparator group

Description:

Education Control

Treatment:

Behavioral: Education Control