Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

Sponsor
Prefectural University of Hiroshima
Study ID
NCT07693062
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Nociplastic Pain

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Multimodal Lifestyle Approach Using a Pain Education Booklet — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Multimodal Lifestyle Approach
    Participants in this single-arm study will receive a 12-week booklet-based multimodal lifestyle intervention, together with exercise therapy as part of usual outpatient rehabilitation. The intervention focuses on pain education, goal setting, shared decision-making, lifestyle-related self-management, recovery-oriented activities, and exercise or physical activity guidance.

Primary Outcome Measure

Feasibility Outcome: Consent Rate [ Time Frame: From the start of recruitment until completion of participant enrollment ]

Central Contacts

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