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NCT Number: NCT07693062

Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prefectural University of Hiroshima, Mihara, Hiroshima, Japan

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About this study

Chronic pain has a substantial impact on activities of daily living, quality of life, work participation, and socioeconomic burden. Chronic pain is understood within a biopsychosocial framework, and modifiable lifestyle factors such as sleep, stress, physical activity, and exercise may contribute to the persistence or exacerbation of pain. In recent years, nociplastic pain has been recognized as an important mechanism in some patients with chronic pain that cannot be fully explained by nociceptive or neuropathic pain alone. Nociplastic pain may be associated with widespread pain, hyperalgesia, sleep disturbance, fatigue, mood and cognitive symptoms, and sensory hypersensitivity. A multimodal lifestyle approach, which combines pain education with individualized support for lifestyle factors such as physical activity, exercise, sleep, and stress management, may be useful for patients with chronic pain showing nociplastic pain features. Therefore, this study will evaluate the feasibility and preliminary effectiveness of a booklet-based multimodal lifestyle intervention in an outpatient clinical setting. This initial feasibility study will focus on a general outpatient chronic pain population with suspected nociplastic pain features, while excluding specific or complex pain-related conditions that may require specialized management. As this is a single-arm pilot feasibility study delivered within usual outpatient rehabilitation, preliminary effectiveness outcomes will be interpreted exploratorily and will not be used to estimate causal effects. The findings will inform the feasibility, acceptability, and design of a future controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility Outcome: Consent Rate

    Time frame: From the start of recruitment until completion of participant enrollment

    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.

  2. Feasibility Outcome: Intervention Completion Rate

    Time frame: Baseline to 12 weeks

    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.

  3. Feasibility Outcome: Participant Satisfaction and Acceptability

    Time frame: 6 weeks and 12 weeks

    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.

  4. Feasibility Outcome: Adverse Events

    Time frame: Screening to 12 weeks

    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.

  5. Pain Intensity

    Time frame: Screening, 6 weeks, and 12 weeks

    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.

Secondary outcomes

  1. Pain Interference

    Time frame: Baseline, 6 weeks, and 12 weeks

    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.

  2. Pain-Related Disability

    Time frame: Baseline, 6 weeks, and 12 weeks

    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.

  3. Central Sensitization-Related Symptoms

    Time frame: Screening, 6 weeks, and 12 weeks

    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.

  4. Pressure Pain Threshold

    Time frame: Baseline, 6 weeks, and 12 weeks

    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.

  5. Temporal Summation

    Time frame: Baseline, 6 weeks, and 12 weeks

    Temporal summation of pain will be assessed using repeated pinprick stimulation. The temporal summation response will be calculated as the change in pain rating from the initial stimulus to repeated stimuli. Higher values indicate greater temporal summation of pain.

  6. Conditioned Pain Modulation

    Time frame: Baseline, 6 weeks, and 12 weeks

    Conditioned pain modulation will be assessed using pressure stimulation as the test stimulus and a conditioning stimulus. The conditioned pain modulation response will be calculated as the change in pressure pain threshold or pain rating during the conditioning stimulus compared with the test stimulus alone. Greater pain inhibition indicates more efficient endogenous pain modulation.

  7. Pain Catastrophizing

    Time frame: Baseline, 6 weeks, and 12 weeks

    Pain catastrophizing will be assessed using the short form of the Pain Catastrophizing Scale. The total score ranges from 0 to 24, with higher scores indicating greater pain catastrophizing.

  8. Kinesiophobia

    Time frame: Baseline, 6 weeks, and 12 weeks

    Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia-11. The total score ranges from 11 to 44, with higher scores indicating greater fear of movement.

  9. Pain Self-Efficacy

    Time frame: Baseline, 6 weeks, and 12 weeks

    Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire-4. The total score ranges from 0 to 24, with higher scores indicating greater pain self-efficacy.

  10. Anxiety Symptoms

    Time frame: Baseline, 6 weeks, and 12 weeks

    Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-2. The total score ranges from 0 to 6, with higher scores indicating more severe anxiety symptoms.

  11. Depressive Symptoms

    Time frame: Baseline, 6 weeks, and 12 weeks

    Depressive symptoms will be assessed using the Patient Health Questionnaire-2. The total score ranges from 0 to 6, with higher scores indicating more severe depressive symptoms.

  12. Insomnia Symptoms

    Time frame: Baseline, 6 weeks, and 12 weeks

    Insomnia symptoms will be assessed using the Athens Insomnia Scale. The total score ranges from 0 to 24, with higher scores indicating more severe insomnia symptoms.

  13. Body Perception

    Time frame: Baseline, 6 weeks, and 12 weeks

    Body perception will be assessed using a region-specific Fremantle Awareness Questionnaire selected according to the participant's primary pain region: the Fremantle Back Awareness Questionnaire, Fremantle Neck Awareness Questionnaire, Fremantle Shoulder Awareness Questionnaire, or Fremantle Knee Awareness Questionnaire. Each questionnaire has a total score ranging from 0 to 36, with higher scores indicating greater disturbance in body perception for the corresponding body region.

  14. Physical Activity

    Time frame: Baseline, 6 weeks, and 12 weeks

    Physical activity will be assessed using the Global Physical Activity Questionnaire. Total physical activity will be expressed as metabolic equivalent task (MET)-minutes per week. Higher values indicate greater physical activity.

  15. Activity Pacing

    Time frame: Baseline, 6 weeks, and 12 weeks

    Activity pacing will be assessed using the pacing scale of the Patterns of Activity Measure-Pain. The pacing scale score ranges from 0 to 40, with higher scores indicating greater use of activity pacing.

  16. Work Productivity

    Time frame: Baseline, 6 weeks, and 12 weeks

    Work productivity will be assessed using the World Health Organization Health and Work Performance Questionnaire. Work performance will be rated on a scale from 0 to 10, with higher scores indicating better work performance.

  17. Health-Related Quality of Life

    Time frame: Baseline, 6 weeks, and 12 weeks

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire. The index score will be calculated using the Japanese value set. Scores range from -0.025 to 1.000, with higher scores indicating better health-related quality of life.

  18. Goal Attainment

    Time frame: Baseline, 6 weeks, and 12 weeks

    Individualized goal attainment will be assessed using Goal Attainment Scaling. Each goal will be rated on a 5-point scale from -2 to +2, where -2 indicates much less than the expected outcome, 0 indicates the expected outcome, and +2 indicates much more than the expected outcome. Higher scores indicate greater goal attainment.

  19. Grip Strength

    Time frame: Baseline, 6 weeks, and 12 weeks

    Grip strength will be assessed using a handgrip dynamometer. Grip strength will be recorded in kilograms, with higher values indicating greater muscle strength.

  20. Two-Step Test

    Time frame: Baseline, 6 weeks, and 12 weeks

    Physical function will be assessed using the Two-Step Test. The two-step value will be calculated by dividing the maximum length of two steps by the participant's height. Higher values indicate better physical function.

  21. Pain Education Understanding

    Time frame: Baseline, 6 weeks, and 12 weeks

    Understanding of pain education will be assessed using pain education understanding ratings.

  22. Global Rating of Change

    Time frame: 6 weeks and 12 weeks

    Participant-perceived overall improvement or worsening will be assessed using the Global Rating of Change Scale. Scores range from -5 to +5, where -5 indicates "very much worse," 0 indicates "no change," and +5 indicates "completely recovered." Higher scores indicate greater perceived improvement.

  23. Treatment Expectancy

    Time frame: Baseline

    Patient perceptions of treatment credibility and treatment expectancy will be assessed using the Credibility/Expectancy Questionnaire. The questionnaire includes treatment credibility items and treatment expectancy items. Scores for each factor range from 3 to 27, with higher scores indicating greater treatment credibility or expectancy.

Study contacts

Contact information is provided by the study sponsor or research team.

Tomohiko Nishigami, PhD

CONTACT

[email protected]

+81 848-60-1120

Sponsors and collaborators

Lead sponsor

Prefectural University of Hiroshima

Other

Registry information

Official study title

Intervention Using a Multimodal Lifestyle Approach for Patients With Chronic Pain Showing Nociplastic Pain Features: A Single-Arm Pilot Feasibility Study

Acronym: MLA-MM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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