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NOT YET RECRUITING
NCT07693062
NA

Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

Sponsor: Prefectural University of Hiroshima

View on ClinicalTrials.gov

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.

Official title: Intervention Using a Multimodal Lifestyle Approach for Patients With Chronic Pain Showing Nociplastic Pain Features: A Single-Arm Pilot Feasibility Study

Key Details

Gender

All

Age Range

20 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-08

Completion Date

2028-12

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

BEHAVIORAL

Multimodal Lifestyle Approach Using a Pain Education Booklet

Participants will receive booklet-based pain education and self-management support using a multimodal lifestyle approach, together with exercise therapy as part of usual outpatient rehabilitation. The intervention will be delivered once per week for 12 weeks, with each session lasting approximately 40 minutes. Core components include goal setting, shared decision-making, pain science education, lifestyle support, recovery-oriented activities, and exercise or physical activity guidance. The first session will include orientation to the booklet and confirmation of pain-related problems and goals. Subsequent sessions will review understanding, progress, and barriers, and adjust goals or self-management strategies as needed. The physiotherapist may tailor the emphasis, exercise content, and self-management strategies according to each participant's symptoms, goals, and response to rehabilitation. Intervention fidelity will be monitored using session records and a checklist.

Locations (2)

Prefectural University of Hiroshima

Mihara, Hiroshima, Japan

SKY Clinic

Ibaraki, Osaka, Japan