Effects of Telerehabilitation Versus Clinical Rehabilitation on Neuropathic Pain, Physical Function and Quality of Life in Chemotherapy Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- NUMERIC PAIN RATING SCALE
研究概览
简要总结
The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life in Chemotherapy induced peripheral neuropathy patients.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is among the most prevalent and debilitating adverse effects of cancer treatment. CIPN increase risk of falls and impair physical function and quality of life (QOL). Physical therapy improves the CIPN symptoms, quality of life and physical function in cancer patients after chemotherapy. Telerehabilitation technologies such as telephone and video conferencing, have the capability of bringing services into the survivors' home and manage the symptoms without needing to have direct physical contact with the hospital or clinic services. The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life.
This study will be a randomized clinical trial that will conducted at Gujranwala institute of Nuclear Medicine hospital in which sixty-six cancer patient who will sustain grade 3 and grade 4 of European Organization for Research and Treatment of Cancer Quality of life-Chemotherapy Induced Peripheral Neuropathy Questionnaire (EORTC-QLQ-CIPN20)will randomly allocated to Group A(n=33)who will receive Telerehabilitation and Group B (n=33) who will receive clinical rehabilitation using the computer generated method. The sample size calculated for this trial will be 66. Interventions will be given in both groups for 60 minutes for 12 weeks (3times per week).10 minutes for Nerve Gliding exercises ,20 minutes for Balance training and 20 minutes forResistance training (using Therapeutic band).European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20) will be used to assess quality of life. Berg balance scale for balance and Manual Muscle testing for muscle strength. The data will be entered and analyzed using SPSS 26. Statistical significance will be set at p=0.05. Normality of data will be assessed through Kolmogorov-Smirnov test. Assessment will be carried out at baseline,6th week, 12th week after discontinuation of treatment and 18th week follow up. For between group analysis of parametric data Independent T test will be used, while Mann Whitney test will be applied for non-parametric data. For within group comparison repeated measure ANOVA will be used, for non-parametric data, Friedman ANOVA will be applied.
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)
盲法说明
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with breast cancer.
- •Patients of age between 45 to 75years.
- •Patient expected to survive for 6 month or more.
- •Patient after specific chemotherapy such as taxanes(paclitaxel),vinca alkaloids(vinorelbine),bortezomib, lenalidomide and platinum-based.
- •Patient with Stage 1 to
- •Patients have prior history of mechanical nerve entrapment without clinical symptoms (carpal tunnel syndrome) were included.
- •Patient who sustained grade 3 and 4 of European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20).
排除标准
- •Patients with history of peripheral neuropathy.
- •Participants are excluded if they had comorbid conditions causing peripheral neuropathic symptoms (including previous chemotherapy or diabetes or alcohol abuse and non-alcoholic liver diseases.
- •Patients not scheduled for one of the aforementioned taxane-based regimens.
- •Patients with vitamin D or B12 deficiency.
- •Non-ambulatory Patients.
- •Patients reluctant to practice exercise program.
- •Patient have impaired visual or vestibular system and presence of bone or any kind of central nervous system involvement , including cancer.
研究组 & 干预措施
Group A (telerehabilitation of neuropathic pain, physical function and quality of life)
Group A will receive Telerehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks.
- warm up of 5 minutes
- Nerve gliding exercises of 10 minutes
- Balance exercises of 20 minutes
- Resistance training of 20 minutes
- cold down of 5 minutes
干预措施: Telerehabilitation (Other)
Group B (clinical rehabilitation of neuropathic pain, physical function and quality of life)
Group B will receive Clinical rehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks.
- warm up of 5 minutes
- Nerve gliding exercises of 10 minutes
- Balance exercises of 20 minutes
- Resistance training of 20 minutes
- cold down of 5 minutes
干预措施: Clinical rehabilitation (Other)
结局指标
主要结局
NUMERIC PAIN RATING SCALE
时间窗: 12th week
Numeric Pain Rating Scale (NPRS) rated CIPN pain. The NPRS is an 11point scale (0-10) ranking pain from 0, indicating no pain at all, to 10, indicating worst pain imaginable on each assessment visit, of the finger tips. This was to identify pain specific to CIPN. A change score of 2 is reported to be a clinically relevant change. The numeric pain rating scale was used for pain measurement , the reliability of which is reported to be between 85% and 95%.
EORTC CIPN20
时间窗: 12th week
The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents. The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The Chinese version of the EORTC QLQ-CIPN20 demonstrated acceptable reliability, validity and responsiveness and was found comparable in measuring CIPN among Chinese cancer patients.The questionnaire consists of sensory and motor neuropathy scales, autonomic scales for dizziness, blurred vision, and erectile dysfunction. The results obtained were converted into a 0-100 scale, with higher results indicating a higher degree of peripheral neuropathy.
The Berg balance scale (BBS):
时间窗: 12th week
Is considered the criterion standard in functional balance evaluation. In total, 14 different activities are scored between 0 (worst) and 4 (best), according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of the patient is good, and lower scores denote poor balance established the validity and reliability of the Turkish version of the BBS.
Manual Muscle testing (MMT)
时间窗: 12th week
Is the most commonly used method for documenting impairments in muscle strength. Because of the variability possible during MMT, several studies examining MMT have used specialized instrumentation to provide support for the extremity tested and for standardization of joint position. Throughout its history manual muscle testing has been performed by practitioners' hands. Lamb states (1985) that MMT has content validity because the test construction is based on known physiologic, anatomic and kinesiologic principles. A number of research papers have dealt with this specific aspect of MMT in the diagnosis of patients.
次要结局
未报告次要终点