Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain

NCT05020470 | Completed DMC

• 1 other identifier: IRB00290512
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Chronic Pain; Musculoskeletal; Auricular Point Acupressure

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.

  Up to 4 months

• Pain Interference

  The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, was used to assess the impact of back pain on their daily functioning. The score ranged from 0 (no disability) to 24 (maximum disability).

  Up to 4 months

• Physical Function

  The Oswestry Disability Index (ODI) was used to measure a participants impairment and quality of life on 10 items with 0-5 point scales. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5; a lower score indicates less disability.

  Up to 4 months

Secondary Outcomes (6)

• Health Related Quality of Life (HRQoL)

  Up to 4 months

• Treatment Satisfaction

  Up to 4 months

• Fear-Avoidance

  Up to 4 months

• Placebo effect

  Up to 4 months

• Pain and Catastrophizing Scale (PCS)

  Up to 4 months

Study Arms (3)

Self-guided mAPA (S-mAPA)

EXPERIMENTAL

S-mAPA group will be provided with instructions so that participants can learn to self-administer APA weekly for four weeks and then followed by weekly telecommunication for Q \& As.

Device: Virtual Auricular Point Acupressure (APA)

In-Person Training + mAPA (IP-mAPA)

EXPERIMENTAL

Participants will receive one in-person training after baseline data is collected and then will self-administer APA on the same schedule with weekly telecommunication as those in the mAPA group.

Device: Virtual Auricular Point Acupressure (APA); Other: In-Person Training

Usual Care Control (UC)

ACTIVE COMPARATOR

Participants will receive usual care only for their pain; after enrolled, patients will receive weekly telecommunication to control for attention and time. The content of the phone/video call will focus on the pain problem they have and the investigators will provide additional information published by the National Center for Complementary and Integrative Health "Chronic Pain: In-Depth" (https://www.nccih.nih.gov/health/chronic-pain-in-depth) which the investigators used in the R01 study for participants enrolled in the control group

Other: Usual Care

Interventions

Virtual Auricular Point Acupressure (APA) DEVICE

Participants will learn how to self-administer APA by themselves.

In-Person Training + mAPA (IP-mAPA); Self-guided mAPA (S-mAPA)

In-Person Training OTHER

Participants will receive in-person training to self-administer APA.

In-Person Training + mAPA (IP-mAPA)

Usual Care OTHER

Participants will continue to do whatever they are instructed by theirs physicians.

Usual Care Control (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (5)

• 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.

  PMID: 36072397 BACKGROUND

• 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.

  PMID: 34961729 BACKGROUND

• 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.

  PMID: 33623727 BACKGROUND

• 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.

  PMID: 36429591 RESULT

• Kawi J, Yeh CH, Grant L, Huang X, Wu H, Hua C, Christo P. Retention, adherence, and acceptability testing of a digital health intervention in a 3-group randomized controlled trial for chronic musculoskeletal pain. Complement Ther Med. 2024 May;81:103030. doi: 10.1016/j.ctim.2024.103030. Epub 2024 Mar 2.

  PMID: 38437926 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chao Hsing Yeh, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

• Jennifer Kawi, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants cannot be masked to the three treatment groups. The PI and Co-Is will be blinded regarding group assignment and will not contact or interact with the participants during the intervention and outcome assessments. Data collector for outcome assessments will be blinded since there will be no seeds placed on the ears when the data are collected.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: September 22, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)