Intervention Using a Multimodal Lifestyle Approach for Patients With Chronic Pain Showing Nociplastic Pain Features: A Single-Arm Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility Outcome: Consent Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Feasibility Outcome: Consent Rate
时间窗: 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.
Feasibility Outcome: Intervention Completion Rate
时间窗: 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.
Feasibility Outcome: Participant Satisfaction and Acceptability
时间窗: 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.
Feasibility Outcome: Adverse Events
时间窗: 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.
Pain Intensity
时间窗: 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.
次要结局
- 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)
- Conditioned Pain Modulation(Baseline, 6 weeks, and 12 weeks)
- Pain Catastrophizing(Baseline, 6 weeks, and 12 weeks)
- Kinesiophobia(Baseline, 6 weeks, and 12 weeks)
- Pain Self-Efficacy(Baseline, 6 weeks, and 12 weeks)
- Anxiety Symptoms(Baseline, 6 weeks, and 12 weeks)
- Depressive Symptoms(Baseline, 6 weeks, and 12 weeks)
- Insomnia Symptoms(Baseline, 6 weeks, and 12 weeks)
- Body Perception(Baseline, 6 weeks, and 12 weeks)
- Physical Activity(Baseline, 6 weeks, and 12 weeks)
- Activity Pacing(Baseline, 6 weeks, and 12 weeks)
- Work Productivity(Baseline, 6 weeks, and 12 weeks)
- Health-Related Quality of Life(Baseline, 6 weeks, and 12 weeks)
- Goal Attainment(Baseline, 6 weeks, and 12 weeks)
- Grip Strength(Baseline, 6 weeks, and 12 weeks)
- Two-Step Test(Baseline, 6 weeks, and 12 weeks)
- Pain Education Understanding(Baseline, 6 weeks, and 12 weeks)
- Global Rating of Change(6 weeks and 12 weeks)
- Treatment Expectancy(Baseline)
研究者
Tomohiko Nishigami
Professor
Prefectural University of Hiroshima