Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

NCT07693062 | Not Yet Recruiting

• 1 other identifier: 26MH005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Pain; Nociplastic Pain

Keywords

Chronic pain; Nociplastic pain; Multimodal lifestyle approach

Outcome Measures

Primary Outcomes (5)

• 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.

  From the start of recruitment until completion of participant enrollment

• 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.

  Baseline to 12 weeks

• 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.

  6 weeks and 12 weeks

• 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.

  Screening to 12 weeks

• Pain Intensity

  Pain intensity will be assessed using the pain intensity items of the Brief Pain Inventory. Each item is rated on an 11-point numeric rating scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." The mean score ranges from 0 to 10, with higher scores indicating greater pain intensity. Screening pain intensity will be used to confirm eligibility, and follow-up assessments at 6 and 12 weeks will be used to explore changes over time.

  Screening, 6 weeks, and 12 weeks

Secondary Outcomes (23)

• Pain Interference

  Baseline, 6 weeks, and 12 weeks

• Pain-Related Disability

  Baseline, 6 weeks, and 12 weeks

• Central Sensitization-Related Symptoms

  Screening, 6 weeks, and 12 weeks

• Pressure Pain Threshold

  Baseline, 6 weeks, and 12 weeks

• Temporal Summation

  Baseline, 6 weeks, and 12 weeks

Study Arms (1)

Multimodal Lifestyle Approach

EXPERIMENTAL

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.

Behavioral: Multimodal Lifestyle Approach Using a Pain Education Booklet

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.

Multimodal Lifestyle Approach

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prefectural University of Hiroshima: lead

Study Sites (2)

Prefectural University of Hiroshima

Mihara, Hiroshima, 725-0053, Japan

Location

SKY Clinic

Ibaraki, Osaka, 567-0829, Japan

Location

MeSH Terms

Conditions

Chronic Pain; Nociplastic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomohiko Nishigami, PhD

  Prefectural University of Hiroshima

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomohiko Nishigami, PhD

CONTACT

+81 848-60-1120; tomon@pu-hiroshima.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single-center, single-arm, pre-post pilot feasibility study.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)