Chronic Knee Pain, Chronic Pain (Back / Neck), Chronic Pain Management, Joint Pain
Conditions
Keywords
Chronic Pain, Rural population, Self-management, Chronic musculoskeletal pain, Auricular point acupressure
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALAuricular Point Acupressure (APA) - Self Management (SM)
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.
BEHAVIORALEducation Control
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).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey | Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in depression as assessed by the Patient Health Questionnaire (PHQ2 ) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From | Baseline, post intervention (4 weeks after baseline) | This consist of six-item questionnaire regarding pain severity and nine-item questionnaire regarding pain interference. Higher score indicates greater pain severity and interference. |
| Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 6b (SF6b) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in sleep duration as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep 6a (+Sleep Duration) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in pain as assessed by the Pain Catastrophizing Scale (PCS6) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in substance use as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance (TAPS1) Substance Use Screener | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in quality of life as assessed by the World Health Organization Quality of Life 2 item (WHOQOL-2) | Baseline, post intervention(4 weeks after baseline) | 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. |
| Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL) | Baseline, post intervention(4 weeks after baseline) | 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. |
| Change in treatment expectancy as assessed by the Healing Encounters and Attitudes Lists (HEAL) | Baseline, post intervention(4 weeks after baseline) | 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. |
| Change in attitude towards complement alternative medicine (CAM) as assessed by the Healing Encounters and Attitudes Lists (HEAL) | Baseline, post intervention (4 weeks after baseline) | 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. |
| Change in analgesics and opioid use as assessed by the Ecological Momentary Assessment (EMA) diary | Baseline, post intervention (4 weeks after baseline) | Daily self-reported analgesic and opioid use (type, dose, frequency) recorded via EMA diary |
| Change in pain self-efficacy influenced by pain as assessed by the Pain Self-Efficacy Questionnaire 2 item Short Form (PSEQ2) | Baseline, post intervention (4 weeks after baseline) | 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. |
Countries
United States
Contacts
Primary ContactJennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
Backup ContactJungkyung Min, PhD, MS, RN
Outcome results
None listed