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Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features (MLA-MM)

3. července 2026 aktualizováno: Tomohiko Nishigami, Prefectural University of Hiroshima

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

15

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Japonsko
    • Hiroshima
      • Mihara, Hiroshima, Japonsko, 725-0053
        • Prefectural University of Hiroshima
        • Kontakt:
    • Osaka
      • Ibaraki, Osaka, Japonsko, 567-0829
        • SKY Clinic
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Multimodal Lifestyle Approach
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.
Behaviorální: Multimodal Lifestyle Approach Using a Pain Education Booklet
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility Outcome: Consent Rate
Časové okno: 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.
From the start of recruitment until completion of participant enrollment
Feasibility Outcome: Intervention Completion Rate
Časové okno: 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.
Baseline to 12 weeks
Feasibility Outcome: Participant Satisfaction and Acceptability
Časové okno: 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.
6 weeks and 12 weeks
Feasibility Outcome: Adverse Events
Časové okno: 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.
Screening to 12 weeks
Pain Intensity
Časové okno: 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.
Screening, 6 weeks, and 12 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Interference
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Pain-Related Disability
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Central Sensitization-Related Symptoms
Časové okno: 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.
Screening, 6 weeks, and 12 weeks
Pressure Pain Threshold
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Temporal Summation
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Conditioned Pain Modulation
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Pain Catastrophizing
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Kinesiophobia
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Pain Self-Efficacy
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Anxiety Symptoms
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Depressive Symptoms
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Insomnia Symptoms
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Body Perception
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Physical Activity
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Activity Pacing
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Work Productivity
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Health-Related Quality of Life
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Goal Attainment
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Grip Strength
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Two-Step Test
Časové okno: 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.
Baseline, 6 weeks, and 12 weeks
Pain Education Understanding
Časové okno: Baseline, 6 weeks, and 12 weeks
Understanding of pain education will be assessed using pain education understanding ratings.
Baseline, 6 weeks, and 12 weeks
Global Rating of Change
Časové okno: 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.
6 weeks and 12 weeks
Treatment Expectancy
Časové okno: 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.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Prefectural University of Hiroshima

Vyšetřovatelé

  • Vrchní vyšetřovatel: Tomohiko Nishigami, PhD, Prefectural University of Hiroshima

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. srpna 2028

Dokončení studie (Odhadovaný)

1. prosince 2028

Termíny zápisu do studia

První předloženo

16. června 2026

První předloženo, které splnilo kritéria kontroly kvality

3. července 2026

První zveřejněno (Aktuální)

9. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 26MH005

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared because a data-sharing plan has not been established and data sharing would require additional ethical and institutional approval.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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