Effectiveness of Ultrasound-guided Percutaneous Electrical Stimulation of the Inferior and Superior Gluteal Nerves as Treatment for Gluteus Maximus and Medius Muscle Dysfunction After an Episode of Low Back Pain: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Dynamic strength gluteus
研究概览
简要总结
Percutaneous ultrasound-guided neuromodulation (US-guided PNM) is the electrical stimulation of a peripheral nerve at some point along its pathway or at a muscular motor point under the guidance of an ultrasound probe with a therapeutic objective.
The application of electrical current to a peripheral motor nerve is associated with a motor response that results in an uncontrolled, anarchic and exaggerated response of the musculature, which is normalized after the application of the electrical current.
In 2016, the authors of the book Invasive Physiotherapy, Fermín Valera and Francisco Minaya, developed by themselves based on the fundamentals of segmental dry needling and neurofunctional acupuncture created by Dr. Alejandro Elorriaga. The authors defined that the application parameters to achieve the best result to the electrical stimulus are controversial, due to the high variability in the literature, but knowing that the most important parameter is the frequency, where studies are observed in which they have used from 2 to 100Hz looking for the motor response.
The parameters of the protocol created are: frequency of 10Hz, pulse width of 250us, with a motor or sensory response, performing 8 stimulations of 8 seconds duration, with 8 seconds of rest, with the aim of improving neuromuscular function, muscle recruitment patterns and motor control.
Although the scientific basis of the authors were 3 articles, none of which were aimed at improving muscle function, but were for neuropathic pain, chronic pain, and treatment of overactive bladder, the basis of clinical observation is correct and many studies currently using their protocol show improvements at the functional level.
In a review of neuromodulation and muscle function, studies that carry out percutaneous stimulation use frequencies of 2Hz to 10Hz, using the protocol of Garrido F. V., Muñoz F. M. , which, as stated above, was not specifically designed to improve muscle function, while the studies that carry out transcutaneous stimulation use much higher frequencies, from 20Hz to 100Hz, all obtaining positive results.
For this reason, and the great difference between the frequencies, the need to carry out specific research on the benefits that percutaneous stimulation with a frequency range of 20-100 HZ.
The hypotheses of this study are,US-guided PNM, with frequency sweeps of 20Hz -100Hz increases static and dynamic strength, more relevantly than current 10Hz protocols.
详细描述
A randomised, double-blind, controlled clinical trial will be conducted in two parallel groups. Intervention group 1 will receive stimulation at 10Hz and intervention group 2 will receive stimulation with frequency sweeps of 20Hz-100Hz.
A period of pre-intervention baseline strength data collection is included to record gluteus maximus and gluteus minimus inhibition.
A single treatment intervention will be performed in the first week, with pre- and post-intervention assessment. Follow-up will last 4 weeks, with pre-intervention, post-intervention, 15 and 30 days post-intervention assessments.
This study follows the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement for pragmatic clinical trials.
The objectives of this study are:
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
The principal investigator, who carries out the intervention, is not masked. The participants and the researchers in charge of analysing the outcome variables are masked.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Healthy patients at the time of inclusion selection.
- •Patients with a history of low back pain, without acute episodes at the time of the study.
- •Patients who show an alteration in the function of the gluteus maximus and gluteus medius by EMG.
- •Patients who show a decrease in the strength of the gluteus maximus and gluteus medius by dynamometry.
- •Patients who have signed the information and consent document for participation.
排除标准
- •Patients with belenophobia.
- •Pregnant patients.
- •Patients with cardiac pathologies or with pacemakers that do not allow electrical stimulation.
- •Patients with low back pain in the acute phase.
- •Patients with chronic low back pain.
- •Patients with skin or immune disorders with contraindications for the application of invasive techniques.
- •Patients who refuse to sign the informed consent or to participate in the study.
- •Individuals who are planning a change in their lifestyle that involves a change in relation to physical activity or training.
研究组 & 干预措施
Valera & Minaya protocol
US-guided PNM with the conventional frequency of the Valera Minaya protocol, with localised location on the peripheral nerve. Stimulation of the upper gluteal nerve and lower gluteal nerve will be performed, with 10 stimulations, with 10 seconds of stimulation and 10 seconds of rest, at a frequency of 10 Hz, with a pulse amplitude of 250 μs, and of maximum intensity tolerable by the patient that causes an exacerbated muscle contraction.
干预措施: Valera & Minaya protocol (Device)
High-frequency PNM
High-frequency US-guided PNM with localised peripheral nerve location. Ten 10-second stimulations of the upper gluteal nerve and lower gluteal nerve will be performed, with frequency sweeps of 20Hz -100Hz with a pulse amplitude of 250 μs, and of maximum intensity tolerable by the patient that causes an exacerbated muscle contraction, with 10 seconds of rest between each stimulation.
干预措施: High-frequency US-guided PNM (Device)
结局指标
主要结局
Dynamic strength gluteus
时间窗: Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention
digital dynamometer, Wagner Force TenTM Digital Force Cage Algometer, FPX25, Massachusetts, USA.
次要结局
- Isometric strenght gluteous(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Contraction speed(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Fatigue resistance(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Power(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Jump(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Reactivity(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Range of motion(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
- Electromiography(Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention)
研究者
Marc Badia
physiotherapist
Universidad de Zaragoza
