The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 6
- 主要终点
- Change in Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.
详细描述
A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used. Patient with non- specific chronic low back pain will be assessed for eligibility. The patients fitting the inclusion criteria will be randomised to receive either the individual CFT or the group classes consisting of education and exercise. Participants' pain, disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general health, stress levels, as well as number and cost of treatments will be evaluated using a range of outcome measures at the start and on completion of the treatment. Patients will receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months after treatment to reassess clinical outcomes. If a participant does not respond to follow-up, they will be telephoned to ask if they wish to complete the questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75
- •Chronic low back pain greater than 6 months duration
- •Score greater than 14% for disability on Oswestry Disability Index (ODI)
- •Independently mobile (with or without aids), to be capable of participating in a rehabilitation programme
排除标准
- •Primary pain area is not the lumbar spine (from T12-buttocks)
- •Leg pain as the primary problem (nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess/central or spinal stenosis with primary leg pain)
- •<6 months post lumbar spine or lower limb or abdominal surgery
- •Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
- •Pregnancy
- •Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)
- •Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
- •Unstable cardiac conditions
- •Red flag disorders like malignancy/cancer, acute traumas like fracture (<6 months ago) or infection, spinal cord compression/cauda equina
结局指标
主要结局
Change in Oswestry Disability Index (ODI)
时间窗: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Used to assess change in disability levels over the course of the trial and follow-up
次要结局
- Back Pain Beliefs Questionnaire(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Numerical rating scale (NRS)(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Socio-economic Conditions Index(Baseline)
- Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)(Measured at baseline)
- Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Nordic Musculoskeletal Screening Questionnaire(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Stress subscale of the Depression, Anxiety and Stress scale (DASS 21)(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Economic evaluation(6, 12 and 36 months)
- Level of co-interventions(Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months)
- Pain Self- Efficacy Questionnaire (PSEQ)(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Subjective Health Complaints Inventory (SHC)(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
- Patient Satisfaction Questionnaire(At 8-14 weeks)
- Medication usage(Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)