Clinical trial NCT05020470: Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain
Official title: Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic Pain
Musculoskeletal
Auricular Point Acupressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This prospective, multisite study will randomly assign at least 30 participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). 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. Participants assigned to IP-mAPA but are unable to come in for the in person training can choose to be in the S-mAPA group; this data will be collected. EMA will be used to assess momentary pain outcomes and APA adherence. This pilot study will collect feasibility and pain-related outcomes at more than 1 study site. The consent process will occur virtually (via secure email). Due to the nature of this pilot study, the anticipated enrollment will be a total of at least N = 30.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Up to 4 months
measure: Pain Interference
timeFrame: Up to 4 months
measure: Physical Function
timeFrame: Up to 4 months
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: Up to 4 months
measure: Treatment Satisfaction
timeFrame: Up to 4 months
measure: Fear-Avoidance
timeFrame: Up to 4 months
measure: Placebo effect
timeFrame: Up to 4 months
measure: Pain and Catastrophizing Scale (PCS)
timeFrame: Up to 4 months
measure: Positive Outlook
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Chao Hsing Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada, Las Vegas
name: Jennifer Kawi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawi J, Yeh CH, Lukkahatai N, Hardwicke RL, Murphy T, Christo PJ. Exploring the Feasibility of Virtually Delivered Auricular Point Acupressure in Self-Managing Chronic Pain: Qualitative Study. Evid Based Complement Alternat Med. 2022 Aug 29;2022:8079691. doi: 10.1155/2022/8079691. eCollection 2022.
citation: Yeh CH, Kawi J, Ni A, Christo P. Evaluating Auricular Point Acupressure for Chronic Low Back Pain Self-Management Using Technology: A Feasibility Study. Pain Manag Nurs. 2022 Jun;23(3):301-310. doi: 10.1016/j.pmn.2021.11.007. Epub 2021 Dec 25.
citation: Kawi J, Yeh CH, Li M, Caswell Bs K, Mazraani Md M, Lukkahatai PhD Rn N, Mensah Rn S, Taylor J, Budhathoki C, Christo P. Auricular Point Acupressure Smartphone Application to Manage Chronic Musculoskeletal Pain: A Longitudinal, One-Group, Open Pilot Trial. Glob Adv Health Med. 2021 Jan 22;10:2164956120987531. doi: 10.1177/2164956120987531. eCollection 2021.
citation: Yeh CH, Kawi J, Grant L, Huang X, Wu H, Hardwicke RL, Christo PJ. Self-Guided Smartphone Application to Manage Chronic Musculoskeletal Pain: A Randomized, Controlled Pilot Trial. Int J Environ Res Public Health. 2022 Nov 11;19(22):14875. doi: 10.3390/ijerph192214875.