Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features (NCT07693062) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features
Japan15 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Suspected involvement of nociplastic pain, assessed using a screening procedure based on clinical criteria and grading for chronic nociplastic pain affecting the musculoskeletal system.
. Able and willing to provide written informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility Outcome: Consent Rate
Timeframe: From the start of recruitment until completion of participant enrollment
2
Feasibility Outcome: Intervention Completion Rate
Timeframe: Baseline to 12 weeks
3
Feasibility Outcome: Participant Satisfaction and Acceptability
. 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.
. Cognitive impairment that may affect the assessment procedures or pain education.
. Possibility of pregnancy during the study period.
. Previous experience of Pain Neuroscience Education.