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Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

Not Yet RecruitingNA

Sponsor: Prefectural University of Hiroshima

Conditions: Chronic Pain, Nociplastic Pain

Interventions: Multimodal Lifestyle Approach Using a Pain Education Booklet

Countries: Japan

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 overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Receiving rehabilitation services at the study site.
2. Aged 20 to 75 years.
3. Chronic pain lasting for at least 3 months.
4. Pain intensity of 3 or higher on an 11-point Numerical Rating Scale.
5. Suspected involvement of nociplastic pain, assessed using a screening procedure based on clinical criteria and grading for chronic nociplastic pain affecting the musculoskeletal system.
6. Able and willing to provide written informed consent.

Screening Procedure for Nociplastic Pain Features The involvement of nociplastic pain features will be assessed before enrollment using a structured screening form developed by the research group based on the clinical criteria and grading system for chronic nociplastic pain affecting the musculoskeletal system proposed by Kosek et al. The screening form is not intended to establish a definitive diagnosis of nociplastic pain, but to identify patients with suspected nociplastic pain features for eligibility.

The screening procedure includes assessment of pain duration, pain distribution, possible nociceptive and neuropathic pain mechanisms, hyperalgesia or allodynia, history of hypersensitivity, and comorbid symptoms related to central sensitization. The screening algorithm and assessment items will be documented in the study materials to improve transparency and reproducibility.

Exclusion Criteria:

1. 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.
2. Inability to follow the study schedule.
3. Receiving compensation for absence from work due to a traffic accident or work-related injury.
4. Difficulty using Japanese.
5. Cognitive impairment that may affect the assessment procedures or pain education.
6. Possibility of pregnancy during the study period.
7. Previous experience of Pain Neuroscience Education.

Locations (2)

Mihara, Hiroshima, Japan
Ibaraki, Osaka, Japan