Effects of exercises and yoga asanas on pain, anxiety, quality of sleep, activities of daily living and quality of life in patients with pain in both the legs.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The study protocol was approved by the research ethical committee of School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies. The study will be done in accordance with the national ethical guidelines for biomedical and health research involving human participants- Indian Council of Medical Research (ICMR) guidelines (revised-2017) and guidelines of Helsinki declaration 2013. All the participants will be made to sign the written informed consent prior to the participation into the study. The participants will be taken from outpatient department and education campus of Manna Rachna International Institute of Research and Studies, Faridabad, Haryana.
Following identification of the participants through inclusion and exclusion criteria, a total of 42 subjects will be enrolled for the study. The sampling using randomization (Coin and toss method) will be done and the participants will be assigned alternatively into three groups with 14 participants in each group.
The interventional Group-A will be treated with Physiotherapy exercises and affirmations; Interventional Group-B will get treated yoga asana with affirmation training and comparator Group-C will be treated with physiotherapy with affirmation and yoga with affirmation on alternate day basis. The overall treatment will be offered in all the three groups will be for six weeks. The Group A and B will get intervention on alternate days while Group C will get alternate therapy proposed in Group A and Group B on alternate days for all the six weeks respectively. The subjects will be assessed at Day-0 for baseline data which will be the pre assessment data and finally at Day-42 for the final post intervention assessment.
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
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria Inclusion Criteria
- •Age between of 20-45 years.
- •Newly diagnosed with IRLSSG SCALE (mild- moderate)
- •Having pain more than 3 months (VAS score; 3-8)
- •Both the genders.
- •Untreated with any medication.
- •Disturbed sleep.
- •Reflecting worse QoL (lower score of SF-36).
排除标准
- •Exclusion Criteria
- •Diagnostic case of psychosomatic or psychotic disorder.
- •Any history of sensory loss.
- •Recent history of musculoskeletal or neurological impairments or any neuromuscular disease.
- •No medical complain including BP, Diabetes, renal failure, cardiac pacemaker, pregnancy any other physiological problem.
- •Abnormal NCS findings.
结局指标
主要结局
Primary Outcome
时间窗: Day-0 | Day-42
1. Pain, anxiety and Sleep
时间窗: Day-0 | Day-42
次要结局
- 1.Activities of Daily Living(2. Quality of Life)
研究者
Ms. Antara Bishnu
Manav Rachna International Institute of Research and Studies