Study to assess the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Function, and Quality of Life among Fibromyalgia (FM) patients - 2-arm, parallel-group, pragmatic, randomized clinical superiority trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Resting pain and movement evoked pain
研究概览
简要总结
Fibromyalgia (FM) is a condition with varied and complex presentation with chronic generalized and widespread pain and fatigueness. Various medicines show mild to moderate efficacy in the management FM symptoms, but most of these drugs has very little effect on the pain that is induced by various physical activity and exertions. Recent literature suggests that nonpharmacologic interventions are the treatment of choice to treat the chronic disabling pain and these interventions relatively harmless, low-cost so these approaches can be clubbed with medical. There is strong evidence that therapeutic exercises are very effective in the management of FM, with movement-evoked pain which limits patients’ participation in various activities. Use of nonpharmacologic approaches that decrease movement-evoked pain that might promote the patient to actively participate in activities, this will increase the patients perceived global improvement.3,4
Transcutaneous electrical nerve stimulation (TENS)- it is a machine that delivers current to the surface of skin via surface electrodes. It is a non-invasive nonpharmacological intervention use to control the pain. We are designing a randomized controlled trial to examine and assess the effects of TENS in patients with FM, using a study protocol that does not entail shortcomings and limitations of previous studies. Our primary aim is assessing the efficacy of repeated long-term TENS application on movement-evoked pain in FM patients. Secondary aims to evaluate the effects of TENS on fatigue, function, and QoL outcomes.
Aims and Objective-
Primary objective- To ascertain the differential effects of TENS plus standard treatment on movement-evoked pain and resting pain in FM patients compared with standard treatment alone.
Secondary objective- To assess the effects of TENS on the patient function, quality of life, physical activity, or other associated symptoms, such as anxiety, fatigue, or sleep disturbance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Study participants who are consenting with age group between 18 years to 60 years and qualifying American College of Rheumatology (ACR)- 2016 Revised Diagnostic Criteria for fibromyalgia syndrome and pain intensity on NRS score is 4 or more.
排除标准
- •1.Inability to walk for 6 minutes without assistive device 2.Study participants with in-situ Pacemaker, Spinal fusion or metal implants and Epilepsy 3.Neuropathic or autoimmune disorder, 4.Pregnancy 5.Serious psychiatric or medical condition 6.skin breakdown or wound or infection or skin disease over the site of TENS application.
结局指标
主要结局
Resting pain and movement evoked pain
时间窗: resting and movement-evoked pain just before TENS, just after 2 weeks of TENS application and 2 weeks, and 3 months after application of last TENS on Numerical rating scale (NRS)
次要结局
- patient function, quality of life, physical activity, or other associated symptoms, such as anxiety, fatigue, or sleep disturbance. 6 Minute Walk Test, Fibromyalgia Impact Questionnaire Pain Item, Short-Form-36 (SF-36) v1.0(just before TENS, just after 2 weeks of TENS application and 2 weeks, and 3 months after)
研究者
Dr Rambeer Ghuleliya
Himalayan Institute of Medical Sciences,