Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorPrefectural University of Hiroshima

About this trial

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.

Eligibility criteria

Qualifiers

Receiving rehabilitation services at the study site.

Aged 20 to 75 years.

Chronic pain lasting for at least 3 months.

Pain intensity of 3 or higher on an 11-point Numerical Rating Scale.

Disqualifiers

Presence of specific pain-related conditions or symptoms, including fracture, rheumatic disease, musculoskeletal surgery within the past 3 years, fibromyalgia, or complex regional pain syndrome.

Inability to follow the study schedule.

Receiving compensation for absence from work due to a traffic accident or work-related injury.

Difficulty using Japanese.

Trial design

Treatments tested in this trial

  • Multimodal Lifestyle Approach Using a Pain Education Booklet

Treatment groups

15 Participants
are divided into 1 treatment group