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

Study Purpose

We 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, we developed a smartphone app which will allow the participants to learn to self-administer APA. We 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). We 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07179016
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Texas Health Science Center, Houston
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
Principal Investigator Affiliation	The University of Texas Health Science Center, Houston
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Pain (Back / Neck), Chronic Pain Management, Chronic Knee Pain, Joint Pain

Additional Details

We 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. We will also evaluate implementation outcomes and cost-effectiveness. Our long-term goal is to increase the access and scalability of evidencebased 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.

Arms & Interventions

Arms

Experimental: Arm 1

APA-SM self-guided with remote training

Experimental: Arm 2

APA-SM with in-person training

Active Comparator: Arm 3

Education Control

Interventions

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

APA is a noninvasive and needle-free pain management therapy based on the principle of acupuncture. The APA-SM intervention program is to manage chronic musculoskeletal pain through a mobile app containing APA videos and remote guidance.

Behavioral: - Education Control

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of South Carolina, Columbia 4575352, South Carolina 4597040

Status

Address

University of South Carolina

Columbia 4575352, South Carolina 4597040, 29208

Site Contact

Peiyin Hung, PhD, MSPH

[email protected]

803-777-9867

Fort Worth 4691930, Texas 4736286

Status

Address