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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote APA-SM Training | Experimental | APA-SM self-guided with remote training |
|
| In-person APA-SM Training | Experimental | APA-SM with in-person training |
|
| Pain Education | Active Comparator | Education Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post intervention (4 weeks after baseline) |
| Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN | Contact | 713-500-2293 | Jennifer.Kawi@uth.tmc.edu | |
| Jungkyung Min, PhD, MS, RN | Contact | 979-450-2091 | Jungkyung.Min@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Recruiting | Columbia | South Carolina | 29208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42259555 | Derived | Kawi J, Bolin J, Wu H, Min J, Bora R, Pace S, Akpan IN, Lockman A, Nnaka T. Auricular Point Acupressure Self-Management (APA-SM) program for chronic musculoskeletal pain among rural populations: a protocol for a pragmatic, randomized controlled trial. BMJ Open. 2026 Jun 8;16(6):e117632. doi: 10.1136/bmjopen-2026-117632. |
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We have a Data Management and Sharing Plan and will comply with the policy set forth by NIH.
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|
| 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). |
|
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. |
| Baseline, post intervention (4 weeks after baseline) |
| 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. | Baseline, post intervention (4 weeks after baseline) |
| 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. | Baseline, post intervention (4 weeks after baseline) |
| Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From | This consist of six-item questionnaire regarding pain severity and nine-item questionnaire regarding pain interference. Higher score indicates greater pain severity and interference. | Baseline, post intervention (4 weeks after baseline) |
| Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 6b (SF6b) | This is a six-item questionnaire and each is scored from 1 (unable to do) to 5 (without any difficulty) for a maximum score of 30. Higher score indicates better physical function. | Baseline, post intervention (4 weeks after baseline) |
| Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ) | This is a 24-item questionnaire and each is scored 0 (no) or 1 (yes) for a maximum score of 24. Higher score indicates greater disability. | Baseline, post intervention (4 weeks after baseline) |
| Change in sleep duration as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep 6a (+Sleep Duration) | This is a six-item questionnaire and each is scored from 1 (very good) to 5 (very poor) for a maximum score of 30. Higher scores indicate worse sleep disturbance. It also includes an additional single item (+Sleep Duration) assessing hours and minutes of sleep per night. Higher values indicates longer sleep duration. | Baseline, post intervention (4 weeks after baseline) |
| Change in pain self-efficacy influenced by pain as assessed by the Pain Self-Efficacy Questionnaire 2 item Short Form (PSEQ2) | This is a two-item questionnaire and each is scored from 0 (not at all confident) to 6 (completely confident) for a maximum score of 12. Higher score indicating greater pain self-efficacy. | Baseline, post intervention (4 weeks after baseline) |
| Change in substance use as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance (TAPS1) Substance Use Screener | This is a five-item questionnaire and each is scored from 0 (daily or almost daily) to 4 (never) for a maximum score of 20. Higher score indicates lower substance use. | Baseline, post intervention (4 weeks after baseline) |
| Change in quality of life as assessed by the World Health Organization Quality of Life 2 item (WHOQOL-2) | This is a two-item questionnaire and each is scored from 1 (very poor/dissatisfied) to 5 (very good/satisfied) for a maximum score of 10. Higher score indicating better quality of life. | Baseline, post intervention(4 weeks after baseline) |
| Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL) | This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates greater positive outlook. | Baseline, post intervention(4 weeks after baseline) |
| Change in treatment expectancy as assessed by the Healing Encounters and Attitudes Lists (HEAL) | This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates greater treatment expectancy. | Baseline, post intervention(4 weeks after baseline) |
| Change in attitude towards complement alternative medicine (CAM) as assessed by the Healing Encounters and Attitudes Lists (HEAL) | This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates more positive attitude toward CAM. | Baseline, post intervention (4 weeks after baseline) |
| Change in analgesics and opioid use as assessed by the Ecological Momentary Assessment (EMA) diary | Daily self-reported analgesic and opioid use (type, dose, frequency) recorded via EMA diary | Baseline, post intervention (4 weeks after baseline) |
| University of North Texas Health Science Center at Fort Worth | Not yet recruiting | Fort Worth | Texas | 76107 | United States |
|
| The University of Texas Health science Center at Houston | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D043384 | Glutamyl Aminopeptidase |
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D000626 | Aminopeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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