Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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

Primary outcome measures

• Feasibility Outcome: Consent Rate [Time frame: From the start of recruitment until completion of participant enrollment]
• Feasibility Outcome: Intervention Completion Rate [Time frame: Baseline to 12 weeks]
• Feasibility Outcome: Participant Satisfaction and Acceptability [Time frame: 6 weeks and 12 weeks]
• Feasibility Outcome: Adverse Events [Time frame: Screening to 12 weeks]
• Pain Intensity [Time frame: Screening, 6 weeks, and 12 weeks]

Secondary outcome measures (12)

• Pain Interference [Time frame: Baseline, 6 weeks, and 12 weeks]
• Pain-Related Disability [Time frame: Baseline, 6 weeks, and 12 weeks]
• Central Sensitization-Related Symptoms [Time frame: Screening, 6 weeks, and 12 weeks]
• Pressure Pain Threshold [Time frame: Baseline, 6 weeks, and 12 weeks]
• Temporal Summation [Time frame: Baseline, 6 weeks, and 12 weeks]
• Conditioned Pain Modulation [Time frame: Baseline, 6 weeks, and 12 weeks]
• Pain Catastrophizing [Time frame: Baseline, 6 weeks, and 12 weeks]
• Kinesiophobia [Time frame: Baseline, 6 weeks, and 12 weeks]
• Pain Self-Efficacy [Time frame: Baseline, 6 weeks, and 12 weeks]
• Anxiety Symptoms [Time frame: Baseline, 6 weeks, and 12 weeks]
• Depressive Symptoms [Time frame: Baseline, 6 weeks, and 12 weeks]
• Insomnia Symptoms [Time frame: Baseline, 6 weeks, and 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 2 centers

• Prefectural University of Hiroshima — Mihara
• SKY Clinic — Ibaraki

Identifiers

NCT: NCT07693062 · 26MH005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗