pilot testing a theory-driven self-management intervention for chronic musculoskeletal pain

Conditions: Chronic Musculoskeletal Pain

Summary: the proposed randomized control trial will evaluate auricular point acupressure (apa) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (cmp) outcomes. this study will randomly assign participants into three groups: (1) self-guided mapa (s-mapa), (2) in-person training + mapa (ip-mapa), and (3) usual care control (uc). ema will be used to assess momentary pain outcomes and apa adherence. data will be collected at pre- (t1), post-completion of intervention (t2), follow-ups at post 1m- (primary endpoint) (t3), 2m (t4), and 3m (secondary endpoint, long-term sustained effect) (t5) for a total of four assessments.

chronic musculoskeletal pain (cmp) is the most common self-reported and clinically diagnosed pain condition in the us and costs up to $635 billion annually. analgesics/opioids are the most common treatments utilized by patients with cmp, however, unnecessary opioid use has resulted in the current opioid epidemic. the institute of medicine recommended guidelines for non-pharmacologic, self-management strategies to manage pain. however, these guidelines have not been broadly implemented due to time constraints among healthcare providers, accessibility, patient's beliefs/motivations, and high cost/insurance coverage, especially among socioeconomically disadvantaged and vulnerable patients. auricular point acupressure (apa), a non-invasive procedure, provides acupuncture-like stimulations on ear points using small pellets instead of needles to self-manage pain. the investigator's interdisciplinary team has accumulated extensive evidence (11 clinical trials) supporting the efficacy of interventionist-administered apa to manage pain. the randomized clinical trial (rct) comparing apa to sham apa demonstrated: (1) significant rapid and sustained effect: apa resulted to ≥38% rapid pain relief among participants at three minutes post-apa; \>44% pain relief and \>28% improved physical function at follow-up after 4-weeks apa; (2) reduced use of medications: after 4-weeks of apa, ≥60% of participants reported less use of pain medications; and (3) significant impact on physiological measures: apa controls pain through blocking pro-inflammatory cytokines (il-1β, il-2) and modulating nerve sensitivity. no adverse effects from apa were reported. the investigator's long-term goal is to eliminate pain care disparities and reduce society's reliance on opioids to manage pain. leveraging technology, the proposed study will help advance mapa, a novel, easy-to-initiate, rapid, safe, and non-pharmacologic tool incorporated in a self-management plan to manage pain in real-world settings. the proposed intervention promises to provide important and timely information to advance a non-opioid and self-managed pain treatment.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older. * receiving outpatient pain treatment for cmp condition (e.g., pain in the back, hip, knee, upper extremity, lower extremity, neck, pelvic, headache/migraine). * chronic pain ≥ 4 on a scale of 0-10 point numerical pain, persisting for at least 3 months or has resulted in pain on at least half the days in the past 6 months. exclusion criteria: * disease that might confound therapeutic effects or explanation of outcomes, i.e., infection, malignant tumors, or autoimmune diseases. * severe ear skin issues. * use of some types of hearing aids (size may obstruct the placement of seeds) * concurrent major psychiatric disorder (i.e., participant self-report). * pregnant women will be excluded from the study based on the self-reported data.

Keywords: chronic pain musculoskeletal auricular point acupressure