Redesign of Everyday Activities and Lifestyle With Occupational Therapy for Chronic Pain Patients - A Feasibility Study of an Occupational Therapy Intervention Added a Multidisciplinary Biopsychosocial Treatment at a Danish Pain Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Quality of Life (EQ-5D-5L Index) from baseline to post discharge
研究概览
简要总结
About 20-30% of the Danish population suffers from chronic non-malignant pain. Current evidence suggests that a bio-psychosocial treatment delivered by multidisciplinary teams is the most effective treatment of chronic non-malignant pain. However, the evidence is still missing on the optimal multimodal treatment combination as well as the additional effect of specific treatment modalities.
A lifestyle-focused intervention is considered to be a relevant supplement to the multidisciplinary treatment of chronic non-malignant pain. Occupational therapy (OT) has previously demonstrated effectiveness in changing the lifestyle of adults through a holistic, systems-based approach. To our knowledge, the method has not previously been approved as a part of the multidisciplinary treatment of adults with chronic non-malignant pain.
The aim of this study is to evaluate the feasibility of the lifestyle-oriented OT intervention added to the current treatment for adults with chronic non-malignant pain, to inform the design and conduct of the future RCT.
详细描述
Methods
Design
The feasibility study is designed as a mixed-methods single-arm case series pretest-posttest study. The feasibility of the planned intervention course and the assessment procedures will be evaluated. Forty-eight adults aged 18-65 will receive the lifestyle-oriented OT intervention for 15 weeks in addition to the current multidisciplinary CNMP treatment. The participants will complete assessments for Quality of Life (EQ-5D-5L), Occupational performance (COPM, AMPS), Occupational balance (OBQ), Pain-related Self-efficacy (PSEQ), Physical wake-time activity (actigraphs), BMI (weight and height scale), Waist circumference (measuring tape), Blood pressure (sphygmomanometer), and Central pain sensitization at baseline and upon OT intervention discharge. Adverse events (AE) will be registered.
Satisfaction with the add-on OT treatment among the participants and the multidisciplinary team members will be investigated through qualitative research methods. All the steps of the OT intervention will be evaluated by the participants qualitatively and quantitatively throughout the course. Focus group interviews with the participants and the multidisciplinary team inclusive OTs will be conducted upon the end of the OT intervention.
Ethical standards
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18<65yr, chronic non-malignant pain diagnosis present ≥ 3 mths at the inclusion
排除标准
- •Acute/ sub-acute pain; cancer-related pain; unstable medicine intake over the past four weeks; daily opioid intake >30 mg; headache/migraine; currently diagnosed depression; current substance misuse; severe psychiatric diagnosis; poor Danish speaking skills and participating in other CNMP-treatment programs. Severe psychiatric diagnoses are defined as a mental illness involving distortion in thinking and perception, and leading to significant social and occupational dysfunction, e.g. schizophrenia and schizotypal, delusional, schizoaffective or psychotic disorders, or psychosis.
- •Both, new eligible patients, and those who fulfill the eligibility criteria after an initial opioid intake adjustment course, will be considered.
结局指标
主要结局
Change in Quality of Life (EQ-5D-5L Index) from baseline to post discharge
时间窗: Baseline and 6 months from baseline
The participants will evaluate their subjective health state in domains Mobility, Self-care, Usual activities, Pain/ Discomfort and Anxiety/ Depression on a 5-point Likert scale from 1= having no problems, having slight problems, having moderate problems, having severe problems and 5= being unable to do/having extreme problems.
次要结局
- Change in Occupational Performance and satisfaction from baseline to post discharge(Baseline and 6 months from baseline)
- Change in Motor and Process Skills from baseline to post discharge(Baseline and 6 months from baseline)
- Change in BMI from baseline to post discharge(Baseline and 6 months from baseline)
- Change in Occupational balance from baseline to post discharge(Baseline and 6 months from baseline)
- Change in Physical wake-time activity from baseline to post discharge(Baseline and 6 months from baseline)
- Change in Waist circumference from baseline to post discharge(Baseline and 6 months from baseline)
- Change in Blood pressure from baseline to post discharge(Baseline and 6 months from baseline)
- Change in Pain Self-efficacy from baseline to post discharge(Baseline and 6 months from baseline)
研究者
Svetlana Solgaard Nielsen
BSc/MSc in Health (Occupational Therapy)
Slagelse Hospital