Effectiveness of Monopolar Dielectric Diathermy by Radiofrequency and Supervised Therapeutic Exercise in Pain, Functionality, Mobility of the Spine and Quality of Life of Patients With Non-specific Chronic Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
研究概览
简要总结
A total of 60 people diagnosed with non-specific chronic low back pain of more than 3 months of evolution and who are not currently undergoing any type of treatment will be recruited, with ages between 30 and 65 years. A random distribution will be made into two treatment groups (diathermy combined with supervised therapeutic exercise versus supervised therapeutic exercise). Participants will receive treatment once a week for a period of four weeks, in the physiotherapy laboratories of the University of Almería, with a follow-up evaluation at three weeks and two months after the start of treatment. At their first visit, participants will be screened for study eligibility according to the study inclusion and exclusion criteria, and will be evaluated by a therapist blinded to the intervention. After this face-to-face evaluation, patients will be randomly assigned to one of the two groups and will receive treatment for low back pain according to their random assignment group by two therapists belonging to the research group and trained in the techniques used.
详细描述
After randomization, participants will be assigned to the experimental group (8 sessions of monopolar dielectric diathermy by emission of radiofrequency combined with 8 sessions of supervised therapeutic exercise) or to the control group (8 sessions of supervised exercise). The number of participants will be identical between the groups. The randomization sequence will be performed by the principal investigator.
The number of participants for each group will be 30. The results of the random assignment will be sealed in opaque envelopes before being delivered to the participants.
The outcome assessor and study statistician will be blinded throughout the entire process.
A baseline assessment of the primary and secondary outcome measures will be performed before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two months after the end of the procedure. intervention (follow-up).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain ≥ 3 months.
- •Age between 30 and 67 years old.
- •Score ≥ 4 points on the Roland Morris Disability Questionnaire.
- •Not being receiving physical therapy.
排除标准
- •(1) patients with sensory and/or coagulation disorders; (2) a history of spinal surgery; (3) heart complications; (4) concurrent severe central or peripheral nervous system disease; (5) epilepsy; (6) needle phobia; (7) serious pathologies that can be the main cause of chronic LBP (for example, presence of lumbar stenosis, spondylolisthesis, tumours, etc.); (8) or patients contraindicated for radiofrequency (diathermy).
结局指标
主要结局
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
时间窗: At baseline, at 4 weeks and at 2 months
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
次要结局
- Change from baseline of Pittsburgh Sleep Quality Index (PSQI)(At baseline, at 4 weeks and at 2 months)
- Change from baseline on Quality of Life. SF-36 Health questionnaire.(At baseline, at 4 weeks and at 2 months)
- Change from baseline in disability. Oswestry Low Back Pain Disability Idex.(At baseline, at 4 weeks and at 2 months)
- Change from baseline in pain intensity. Visual analogue scale.(At baseline, at 4 weeks and at 2 months)
- Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, at 4 weeks and at 2 months)
- Change from Mcquade Test.(At baseline, at 4 weeks and at 2 months)
- Change from baseline in range of motion and lumbar segmental mobility(At baseline, at 4 weeks and at 2 months)
- Change from baseline in Hospital Anxiety and Depression Scale (HADS)(At baseline, at 4 weeks and at 2 months)
- Change from baseline in lumbar mobility flexion.(At baseline, at 4 weeks and at 2 months)
研究者
Adelaida María Castro-Sánchez
Principal Investigator
Universidad de Almeria