The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neck Disability Index
研究概览
简要总结
The aim of this study is to compare the effectiveness of Pilates compared with Cognitive Functional Therapy in adults with chronic neck pain.
详细描述
Firstly, people being informed about the study and those who determine eligibility criteria they written informer consent. After this, the participants will be randomized by a single-blind assessor in a 1:1 ration to pilates exercises and cognitive functional therapy. The participants of both groups will receive therapy twice a week for eight weeks.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64
- •Pain in neck area for more than 3 months
- •Pain in NPRS more than 40/100
- •Independently mobility (with or without aid), to be capable of participating in a rehabilitation program twice a week
排除标准
- •Serious psychological pathology
- •Recently surgery on shoulder or neck area (<6 months)
- •Pain relieving procedures such as injection based therapy and day case procedures (e.g. rhizotomy) in the last 3 months
- •Pregnancy
- •Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, Scheuermann's disease)
- •Progressive neurological disease (e.g. Multiple Sclerosis, Parkinson's disease, Motor Neuron Disease)
- •Unstable Cardiac Conditions
- •Red flags disorders (malignancy/cancer, acute traumas like fracture (<6 months ago) or infection, spinal cord compression/cauda equina)
结局指标
主要结局
Neck Disability Index
时间窗: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
This questionnaire informed us about the affection to have the neck pain in human ability to manage it in everyday life. Measured neck disability with 4 (absence of disability) and \>35 (full disability).
Numerical Rating Scale
时间窗: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
Measured pain intensity with 0 (no pain) and 100 (the worst pain ever).
次要结局
- Range of Motion(baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization)
- EuroQol (EQ-5D)(baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization)
- Isometric Strength(baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization)
- Fear Avoidance Beliefs Questionnaire(baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization)
- Short Form 12(baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization)
研究者
Evi Lazoura
Physiotherapist, MSc, PhD (cand.)
European University Cyprus