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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Auricular Point Acupressure (APA) - Self Management (SM)

    Behavioral

    APA is a noninvasive and needle-free pain management therapy based on the principles of acupuncture. The APA-SM intervention program is aimed to manage chronic musculoskeletal pain leveraging a mobile app containing APA videos and remote vs in-person guidance or coaching to practice APA based on APA study assignment.

  • Education Control

    Behavioral

    Education Control group receive an app but the content will be specific to pain and self-management (no APA content) and they practice pain self-management skills (no APA practice).

Treatment groups

693 Participants
are divided into 3 treatment groups
Group A: Remote APA-SM TrainingExperimental treatment 1 intervention
Group B: In-person APA-SM TrainingExperimental treatment 1 intervention
Group C: Pain EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey

This is a three-item questionnaire and each is scored from 0 (no pain) to 10(worst pain) for a maximum score of 30. Higher score indicating worse outcome

Time frame
Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months

Secondary outcomes

1

Change in pain as assessed by the Pain Catastrophizing Scale (PCS6)

This is a six-item questionnaire and each is scored from 0 (not at all) to 4 (all the time) for a maximum score of 24. Higher score indicating greater pain catastrophizing.

Time frame
Baseline, post intervention (4 weeks after baseline)
2

Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ)

This is a 16-item questionnaire. Each item is scored from 0 (completely disagree) to 6 (completely agree) for a maximum score of 96. Higher score indicating greater fear-avoidance beliefs.

Time frame
Baseline, post intervention (4 weeks after baseline)
3

Change in depression as assessed by the Patient Health Questionnaire (PHQ2 )

This is a two-item questionnaire and each is scored from 0 (not at all) to 3(nearly every day) for a maximum score of 6. Higher score indicating greater depression.

Time frame
Baseline, post intervention (4 weeks after baseline)
4

Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2)

This is a two-item questionnaire and each is scored from 0 (not at all) to 3 (nearly every day) for a maximum score of 6. Higher score indicating more anxiety.

Time frame
Baseline, post intervention (4 weeks after baseline)

Other outcomes

Sponsors and contacts

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