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

Browse trials for

• Chronic Pain 2,930
• Arthralgia 273

Keywords

• Chronic Pain
• Rural population
• Self-management
• Chronic musculoskeletal pain
• Auricular point acupressure

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 693 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  Remote APA-SM Training

  APA-SM self-guided with remote training

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

• Experimental
  In-person APA-SM Training

  APA-SM with in-person training

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

• Active comparator
  Pain Education

  Education Control

  Behavioral: Education Control

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).

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)

5. 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.

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

6. 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.

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

7. 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.

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

8. 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.

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

9. 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.

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

10. 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.

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

11. 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.

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

12. 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.

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

13. 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.

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

14. 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.

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

15. 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

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

Publications

• 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. PubMed 42259555 ↗

Individual participant data

Plan to share: No — We have a Data Management and Sharing Plan and will comply with the policy set forth by NIH.