Effectiveness of telerehabilitation and home-based exercise program on pain, disability, self-efficacy and coping in postpartum low back pain – A Randomised controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Oswestry Disability Questionnaire.
研究概览
简要总结
This study will help to find out the effectiveness of telerehabilitation and home-based exercise program on pain, disability, self-efficacy, and coping in postpartum women with low back pain. In this randomized controlled trial, subjects between the age group of 18-35 years with postpartum low back pain will be included. Subjects will be assessed for pain intensity, disability, self-efficacy, and coping. Subjects will be allocated to the groups using sealed opaque envelopes. The investigator and subjects will be blinded. Participants will receive 8 treatment sessions for 4 weeks (2 sessions per week for both groups). Each session will be of 30-45 minutes. Group A will receive Telerehabilitation Intervention under the therapist’s supervision (where the therapist will demonstrate the exercises via WhatsApp videoconference and same will be done by the Participant) and Group B will receive a Home-Based Exercise Program where the subject will be taught exercises on the first day and will be given a booklet containing a set of exercises for 4 weeks, the therapist will make a call to the subject weekly once for 4week to check the adherence to the protocol. Assessment of outcome measures will be done at the baseline E1 (first day in the hospital, Pre-intervention) and E2(at the last session i.e., 4th week) respectively for both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women pointing at low back area on the body chart and who fits the definition of postpartum low back pain i.e., a pain in the lower lumbar region and is multifactorial in nature.
- •Women between the age group of 18-35 years.
- •All the postpartum women ranging from 3rd–6th month.
- •Cesarean or vaginal delivery.
- •women who are living in the area served by high-speed internet services.
排除标准
- •Women not willing to give the consent 2)Radiculopathy.
- •Known case of Systemic diseases/ gynaecological diseases / tumour/ infection 4)Known case of spinal/congenital deformities/fracture 5)Psychiatric illness 6)Any previous lumbar or abdominal surgery except caesarean Section.
- •women who are not living in the area served by high-speed internet services or does not have the feature of video calling in their cell phones.
结局指标
主要结局
Oswestry Disability Questionnaire.
时间窗: at the baseline E1 (first day in the hospital, Pre intervention) and E2(at the last session i.e., 4th week) respectively for both the groups.
Pain self-efficacy Questionnaire.
时间窗: at the baseline E1 (first day in the hospital, Pre intervention) and E2(at the last session i.e., 4th week) respectively for both the groups.
Coping Strategies Questionnaire-Revised.
时间窗: at the baseline E1 (first day in the hospital, Pre intervention) and E2(at the last session i.e., 4th week) respectively for both the groups.
Nordic Body chart.
时间窗: at the baseline E1 (first day in the hospital, Pre intervention) and E2(at the last session i.e., 4th week) respectively for both the groups.
Visual Analog Scale.
时间窗: at the baseline E1 (first day in the hospital, Pre intervention) and E2(at the last session i.e., 4th week) respectively for both the groups.
次要结局
未报告次要终点