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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Multimodal Lifestyle Approach Using a Pain Education Booklet
BehavioralParticipants 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Multimodal Lifestyle ApproachExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility Outcome: Consent Rate
The proportion of eligible patients who provide written informed consent to participate in the study. The feasibility criterion for consent will be met if at least 50% of eligible patients provide written informed consent.
Time frame
From the start of recruitment until completion of participant enrollment2
Feasibility Outcome: Intervention Completion Rate
The proportion of enrolled participants who complete the 12-week multimodal lifestyle approach intervention program. Dropouts, withdrawals, and reasons for non-completion will also be recorded. The feasibility criterion for intervention completion will be met if at least 70% of enrolled participants complete the intervention program.
Time frame
Baseline to 12 weeks3
Feasibility Outcome: Participant Satisfaction and Acceptability
Participant satisfaction and acceptability of the multimodal lifestyle approach intervention program will be assessed using satisfaction ratings and a semi-structured interview at 12 weeks. The interview will explore useful components of the intervention, the most useful content and reasons, and suggestions for improvement. The feasibility criterion for satisfaction will be met if the median participant satisfaction rating is at least 8 out of 10.
Time frame
6 weeks and 12 weeks4
Feasibility Outcome: Adverse Events
The occurrence, type, and severity of adverse events related to assessment, pain education, self-management support, or exercise therapy during the study period will be recorded. The feasibility criterion for safety will be met if no serious adverse events definitely or probably related to the intervention occur during the study period.
Time frame
Screening to 12 weeksSecondary outcomes
1
Pain Interference
Pain interference will be assessed using the interference items of the Brief Pain Inventory. Each item is rated on an 11-point numeric rating scale from 0 to 10, where 0 indicates "does not interfere" and 10 indicates "completely interferes." Higher scores indicate greater pain interference.
Time frame
Baseline, 6 weeks, and 12 weeks2
Pain-Related Disability
Pain-related disability will be assessed using the Pain Disability Index. The total score ranges from 0 to 70, with higher scores indicating greater pain-related disability.
Time frame
Baseline, 6 weeks, and 12 weeks3
Central Sensitization-Related Symptoms
Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory. The total score ranges from 0 to 100, with higher scores indicating more severe central sensitization-related symptoms.
Time frame
Screening, 6 weeks, and 12 weeks4
Pressure Pain Threshold
Pressure pain threshold will be measured using a pressure algometer. The pressure pain threshold is defined as the minimum pressure intensity at which the participant first perceives the stimulus as painful. Higher values indicate lower mechanical pain sensitivity.
Time frame
Baseline, 6 weeks, and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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