跳至主要内容
临床试验/NCT03104218
NCT03104218已完成不适用

Transcranial Direct Current Stimulation to Enhance Rehabilitation in Individuals With Rotator Cuff Tendinopathy: a Triple-blind Randomized Control Trial

Laval University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change from Functional limitations perceived at week 3,6 and 12.

研究概览

简要总结

Transcranial direct current stimulation (tDCS), an electrostimulation technique known to modulate the motor cortex excitability, has been shown to enhance the effects of rehabilitation in populations with neurological injuries. tDCS could similarly be effective in individuals with rotator cuff (RC) tendinopathy, as this pathology is also associated with pain and motor control deficits. For the treatment of RC tendinopathy, sensorimotor training is effective to reduce pain, increase function and enhance motor control of the shoulder. The addition of tDCS during sensorimotor training could enhance motor learning associated with sensorimotor training and thus improve treatment outcome. PURPOSE: To compare, in terms of symptoms, functional limitations and shoulder control, a group receiving a rehabilitation program centered on sensorimotor training combined with tDCS to a group receiving the same rehabilitation program combined with sham tDCS in individuals with RC tendinopathy. METHODS: Forty adults with RC tendinopathy will take part in the 4 evaluation sessions (0, 3, 6, 12 weeks) and a 6-week rehabilitation program. Outcome measures will be symptoms and functional limitations (Disability of the Arm, Shoulder and Hand and the Western Ontario Rotator Cuff index), as well as acromiohumeral distance ([AHD] ultrasonographic measurement at 0° and 60° of elevation arm). The rehabilitation program will include sensorimotor training, strengthening and education. tDCS will be apply during sensorimotor training on the motor cortex contralateral to the side of pain. A 2-way ANOVA will be used to analyse the effects of tDCS on the outcomes.

详细描述

BACKGROUND: tDCS is a safe and easy to use technique that has emerged as a promising tool to induce plasticity and to facilitate sensorimotor rehabilitation with potential application in various clinical populations. tDCS has been shown to induce changes that outlast the duration of the stimulation, by modulating neuronal membrane potential of the targeted brain region. Depending on the flow of current, tDCS can increase or decrease neuronal excitability; anodal tDCS induces membrane depolarization and enhanced excitability of cortical neurons, whereas cathodal tDCS induces membrane hyperpolarization and reduced excitability of cortical neurons. As such, tDCS has the potential to prime the plastic potential of a given brain region, making it more responsive to another intervention. For example, it has been shown that five days of anodal tDCS combined with training promotes motor skill acquisition still detectable three months later; an effect significantly superior to sham tDCS. These effects most likely are due to the augmentation of synaptic plasticity that requires the presence of brain-derived neurotrophic factor.

Coupled with sensorimotor training, tDCS can lead to subsequent sustained clinical gains.The beneficial effects of tDCS combined with sensorimotor training to normalize motor cortical activity and to enhance rehabilitation have been shown in populations with neurological injuries, such a stroke. In musculoskeletal populations, anodal tDCS over M1 has also been shown to lead to significant pain level reduction. Evidence suggests that tDCS over M1 may relieve pain through inhibition of thalamic sensory neurons and disinhibition of neurons located in the periaqueductal gray matter. In these latter studies, tDCS was specifically aimed at reducing pain and was not coupled with sensorimotor training. In fact, evidence on the effect of tDCS coupled with sensorimotor training in musculoskeletal populations is scarce, and the effect of such intervention has never been evaluated in individuals with RC tendinopathy. Considering that RC tendinopathy is associated with impaired motor control and that pain can decrease the excitability of the motor cortex and impair motor learning, the investigators believe that it is relevant to determine whether tDCS can enhance sensorimotor training, and improve outcome.

PURPOSE - The primary objective of this randomized control trial is to compare, in terms of symptoms and functional limitations, a group receiving a rehabilitation program centered on sensorimotor training combined with anodal tDCS to a group receiving the same rehabilitation program combined with sham tDCS in individuals with RC tendinopathy. A secondary objective is to explore the effects of these interventions on shoulder control and corticospinal excitability.

METHODS - Study Design: This triple-blind (patients, therapist & evaluator), parallel-group randomized control trial will include four evaluation sessions over 6 months (baseline, week 3, week 6, 3-month) and a 6-week rehabilitation program.

Interventions: Each participant will take part in the same 8-week rehabilitation program supervised by an independent physiotherapist. This program, previously shown effective, targets the deficits described in individuals with RC tendinopathy. It includes sensorimotor training, strengthening, and patient education. Each session lasts 40 minutes, with at least 75% for sensorimotor training. The rest of the session is used to teach and revise home exercises. tDCS will be applied during sensorimotor training (30 min),but only during the first five sessions, as these sessions will be during the first phase of motor learning, characterized by considerable improvement in performance.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

A randomisation list will be established prior to the initiation of the study using a random number generator. The randomisation list will be generated by an independent research assistant not involved in data collection. Allocation will be concealed in sealed and opaque envelopes that will be sequentially numbered. Randomisation will be stratified to ensure balance of the treatment groups with respect to sex. A blocked randomisation will also be used to make sure that two equal groups of 20 participants are obtained. Given that it is possible to blind the treating PT, the participants and the evaluators, a triple-blind design will be used. An independent research assistant from the CIRRIS will open the randomisation envelope indicating the participant's assignment. The research assistant will be blind to the baseline evaluation results. The research assistant will be the one who will set-up the parameters on the tDCS before treatment sessions with tDCS (real or sham tDCS).

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • painful arc of movement
  • positive Neer or Kennedy-Hawkins tests
  • pain on resisted isometric lateral rotation or abduction, or positive Jobe test. The diagnosis accuracy of the combination of these tests has been studied (sensitivity & specificity ≥ 0.74)

排除标准

  • fracture at the symptomatic upper limb;
  • previous neck or shoulder surgery;
  • shoulder pain reproduced during active neck movement;
  • shoulder capsulitis;
  • clinical signs of a full thickness RC tear;
  • rheumatoid, inflammatory, or neurological diseases;
  • behavioural or cognitive problems.

研究组 & 干预措施

tDCS group

Experimental

tDCS will be delivered using a direct current stimulator (constant current of 1.5 mA) via two 35cm2 (5 x 7 cm) saline-soaked surface sponge electrodes (parameters shown effective to enhance training). The center of the active electrode will be positioned over C3/C4 (international 10-20 EEG system; corresponding to the cortical representation of upper limb muscles), contralateral to the side of pain and the reference electrode over the contralateral supraorbital region. Current intensity will be ramped up (0-1.5 mA) and down (1.5-0 mA) over 15 seconds at the beginning and end of the 30 minutes stimulation period.

干预措施: tDCS group (Other)

Placebo group

Sham Comparator

The sham tDCS involves electrodes placed in an identical position to that used for active stimulation; however the stimulation will be turned on for 15 seconds and then off to provide participants with the initial "itching" sensation but without current for the remainder of the period. This procedure has been shown to effectively blind participants to the stimulation condition. The parameters on the tDCS will be set-up by a research assistant before each session. The treating physiotherapist will not have access to the control board of the tDCS.

干预措施: Placebo group (Other)

结局指标

主要结局

Change from Functional limitations perceived at week 3,6 and 12.

时间窗: At week 3, 6, and 12, the self-administered WORC questionnaire will be administered.

Change from Functional limitations at week 3,6 and 12 with WORC (Western Ontario Rotator Cuff Index; self-administered questionnaire)

Change from Symptoms perceived at week 3,6 and 12.

时间窗: At week 3, 6, and 12, the self-administered DASH questionnaires will be administered.

Change from Baseline Symptoms perceived at week 3,6 and 12 with DASH (Disability of the Arm, Shoulder and Hand; self-administered questionnaire)

次要结局

  • Change from US measurement of supraspinatus tendon at week 0 and 6.(US measurement will be performed at week 0 and 6.)
  • Change from Corticospinal excitability of the infraspinatus (IS) muscle at day 1 before the first treatment and day 1 after the first treatment.(Through first tDCS treatment of each participant.)
  • Change from US measurement of AHD at week 0 and 6.(US measurement of AHD will be performed at week 0 and 6.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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