Efficacy of Therapy Using Monopolar Dielectric by Radiofrequency on the Symptoms of Myofascial Trigger Points in Patients With Chronic Non-specific Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changes in pressure algometry (Wagner Algometer) in myofascial trigger points assessment of pressure pain threshold.
研究概览
简要总结
A total of 74 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 35 and 65 years. A random distribution will be made into two treatment groups (monopolar diathermy by radiofrequency versus placebo). Participants will receive treatment three per week for a period of three weeks, in the physiotherapy laboratories of the University of Almería, with a follow-up evaluation post-intervention (one months) and two months after the end 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
The technique of applying monopolar electrical diathermy by radiofrequency emission (MDR), using the Physicalm® device, allows electromagnetic waves to be applied transcutaneously in a capacitive and monopolar manner, making focused energy deposits in the areas compromised with the painful process. The intervention with this device consists of different independent programs adapted to the different modalities of clinical pain. Through adaptations of the digitally modulated electromagnetic signals in terms of their intensity, frequency, form and duration, analgesia and pain relief can be obtained in different conditions musculoskeletal.
Despite being a clinical electrotherapy technique currently widely used by physiotherapists, there are few clinical trials on the application of monopolar electrical diathermy by radiofrequency emission (MDR) in ailments of lumbar origin caused by myofascial trigger points. The difference with other systems that use high-frequency electrophysical agents such as short waves or microwaves lies mainly in the ability to penetrate the tissues, producing a thermal effect at a greater depth.
Due to all the structural and functional alterations that occur in chronic non-specific low back pain, this randomized clinical trial project was born, with the aim of providing an answer to the disabling symptoms suffered by patients with chronic non-specific low back pain, searching for tools of safe and effective treatment from the field of Physiotherapy, which report a benefit in the symptoms, functionality and quality of life of patients diagnosed with chronic non-specific low back pain caused by PGM.
A total of 74 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 35 and 65 years. A random distribution will be made into two treatment groups (monopolar diathermy by radiofrequency versus placebo).
The 37 subjects of the experimental group (EG) will receive an application of monopolar electrical diathermy by radiofrequency emission (MDR) by means of the Physicalm® device (developed by the electro-medicine company Biotronic Advance Develops SL), on the lumbar muscles by means of rotary movements and translation, adapting to the muscle fibers of the lower back, contacting and applying the treatment to the active myofascial trigger points of the following muscles: quadratus lumborum, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. A pulsed emission of 840 KHz and 30v will be carried out dynamically for a treatment time of 20 minutes. 3 weekly sessions will be performed for 3 weeks, a total of 9 treatment sessions.
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)
盲法说明
Participants are not familiar with diathermy, and will lie prone while receiving treatment. They will also be cited on different days of the week to the experimental group.
The therapist assessing the outcome measures does not know which group the patients belong to, and will be supervised by the principal investigator so that they do not ask any questions about it.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LBP for/over three months
- •Age between 30 and 65 years
- •Score equal or superior of four points on the Roland Morris Disability
- •Questionnaire Not currently receiving physical therapy.
排除标准
- •Presence of lumbar stenosis;
- •Any clinical signs of radiculopathy;
- •Diagnosis of spondylolisthesis;
- •Diagnosis of fibromyalgia;
- •Treatment with corticosteroid or oral medication within the past two weeks;
- •A history of spinal surgery;
- •Contraindication for MDR;
- •Disease of the central or peripheral nervous system; (9) Patients with cardiac complications and / or patients who have recently undergone radiotherapy.
结局指标
主要结局
Changes in pressure algometry (Wagner Algometer) in myofascial trigger points assessment of pressure pain threshold.
时间窗: At baseline, at 4 weeks and at 2 months
The algometer consists of a rubber tip and a dial that measures the pressure applied to the MTrP in increments of 0.5 kg. Three measurements were performed for each one of the selected trigger points: iliocostal muscle level L1; multifidus level L2, S1 and S4; quadratus lumbar PGM deep superior, deep inferior, superficial superior and superficial inferior. The average value of 3 repetitive measurements with intervals of 30 to 60 seconds was used for statistical analysis.
Change from baseline in pain intensity. Visual analogue scale.
时间窗: At baseline, at 4 weeks and at 2 months
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
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 in disability. Oswestry Low Back Pain Disability Idex.(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 baseline on Quality of Life. SF-36 Health questionnaire(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 of Pittsburgh Sleep Quality Index (PSQI)(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