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

Официальное название

A Pragmatic, Randomized Controlled Trial of a Auricular Point Acupressure - Self-Management (APA-SM) Program for Chronic Musculoskeletal Pain Among Rural Populations.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Auricular 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.
• Поведенческое Education 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).

Первичные конечные точки

• Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey [Срок оценки: Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months]

Вторичные конечные точки (12)

• Change in pain as assessed by the Pain Catastrophizing Scale (PCS6) [Срок оценки: Baseline, post intervention (4 weeks after baseline)]
• Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Baseline, post intervention (4 weeks after baseline)]
• Change in depression as assessed by the Patient Health Questionnaire (PHQ2 ) [Срок оценки: Baseline, post intervention (4 weeks after baseline)]
• Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, post intervention (4 weeks after baseline)]
• Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, post intervention(4 weeks after baseline)]
• Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL) [Срок оценки: Baseline, post intervention(4 weeks after baseline)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of South Carolina — Columbia
• University of North Texas Health Science Center at Fort Worth — Fort Worth
• The University of Texas Health science Center at Houston — Houston

Публикации

• 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. PMID 42259555

Идентификаторы

NCT: NCT07179016 · HSC-SN-25-0443

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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