Effect of multimodal physical rehabilitation on pain and quality of life in Parkinsons Disease patients with neck and back pain A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- •After including the subjects with pain into the study, to differentiate whether the pain is related to Parkinsons disease or not, the PD Pain Classification Scale (PDPCS) will be utilized. Additionally, the Kings PD Questionnaire will be employed to categorize the pain into various domains.
研究概览
简要总结
The study is being conducted as part of a PhD program under the Kerala University of Health Sciences, Kerala
All preliminary requirements for PhD data collection have been fulfilled, including approvals from the Institutional Scientific Committee, Institutional Ethics Committee, Doctoral Committee, and theProtocol presentation committee of Kerala University of Health Sciences.
The initial research proposal, which included all components to be measured, was submitted. Following the protocol presentation before the Kerala University of Health Sciences, it was recommended to designate two measures as primary outcome measures and the remaining as secondary outcome measures. Accordingly, two ethical clearance certificates have been obtained from the institute, one before the study title has been modified and another after modification,in alignment with the university’s recommendations and ethical standards.
There is no change in content or protocol after the title change, the content remains absolutely the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of Parkinson’s Disease with pain in the neck and back region (McGill Pain Questionnaire) Age 50 to 65 years Subjects with Parkinson’s Disease in the stage of 1 to 3 as per the Modified Hoehn and Yahr scale Subjects with Parkinson’s Disease in the category of score 7-13 in the Short Falls Efficacy Scale International (FES I).
排除标准
- •Subjects not will to give informed consent for study.
- •Subjects with Becks Depression Inventory score 11 and above Subjects with the Montreal Cognitive Assessment (MoCA) score less than 10 Any cardiovascular disease that interrupts exercises All other secondary Parkinson’s Disease and Parkinsonism plus syndrome Inflammatory infective demyelinating disorders of CNS Vestibular dysfunction Recent fractures or surgeries of upper limb, shoulder girdle, ribs and spine Psychiatric and non cooperative patients Intervertebral disc prolapses and other diseases of spine Spinal and upper limb deformities Fixed kyphosis.
结局指标
主要结局
•After including the subjects with pain into the study, to differentiate whether the pain is related to Parkinsons disease or not, the PD Pain Classification Scale (PDPCS) will be utilized. Additionally, the Kings PD Questionnaire will be employed to categorize the pain into various domains.
时间窗: Pre- test score will be assessed on the first day before the treatment. On completion of the treatment of four weeks, post interventional assessment will do and the scores obtained will documented for analysis.
1.McGill Pain Questionnaire for pain
时间窗: Pre- test score will be assessed on the first day before the treatment. On completion of the treatment of four weeks, post interventional assessment will do and the scores obtained will documented for analysis.
2.Visual Analogue Scale for pain
时间窗: Pre- test score will be assessed on the first day before the treatment. On completion of the treatment of four weeks, post interventional assessment will do and the scores obtained will documented for analysis.
3.The Parkinson Disease Questionnaire 39 for Quality of Life
时间窗: Pre- test score will be assessed on the first day before the treatment. On completion of the treatment of four weeks, post interventional assessment will do and the scores obtained will documented for analysis.
次要结局
- 1.Kinovea software for posture(•2.Mcgill’s Torso Muscular Endurance Test Battery for core muscle endurance)
研究者
Remya N.
Dept of Physiotherapy,Little Flower Institute of Medical Sciences and Research, Angamaly, Ernakulam, Kerala. Affiliated to Kerala University of Health Sciences,Thrissur,Kerala