Clinical Trial

Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

Study acronym: MLA-MM
Not Yet Recruiting
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Summary
This single-center, single-arm pilot feasibility study aims to examine the feasibility and preliminary effectiveness of an intervention program using a pain education booklet based on a multimodal lifestyle approach for patients with chronic pain with features of nociplastic pain. Participants will receive pain education and self-management support using a booklet developed by the investigators, together with exercise therapy provided as part of usual outpatient rehabilitation. The intervention includes pain science education, shared decision-making, goal setting, physical activity and exercise, sleep, stress management, diet, work environment, headache-related lifestyle factors, and strategies for recovery-oriented and sustainable activities. Feasibility outcomes include recruitment and consent rates, intervention completion rate, assessment completion rate, participant satisfaction, reasons for dropout, adverse events, and practical difficulties during implementation. Preliminary effectiveness will be explored using patient-reported outcomes and physical function measures at baseline, 6 weeks, and 12 weeks.
Trial Details
NCT Number NCT07693062
Lead Sponsor Prefectural University of Hiroshima
Conditions Chronic Pain, Nociplastic Pain
Enrollment 15 participants
Start Date 2026-08
Primary Completion 2028-08 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-09