Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Western Ontario Rotator Cuff index (WORC)
研究概览
简要总结
This study evaluates the effects of corticosteroid injections over time, as well as the additional effect provided by subsequent transcranial direct current stimulation (tDCS) of the motor cortex on patients with rotator cuff tendinopathy of the shoulder. All patients will receive a subacromial corticosteroid injection. Two weeks later, a third will receive a treatment of tDCS, a third will receive a placebo a-tDCS treatment, and the last third will not receive any additional treatment.
详细描述
Corticosteroid injections (CSI) are often used by physicians in the treatment of rotator cuff tendinopathy, a painful chronic degeneration of the tendons in the shoulder. However, the effect of CSI in comparison with placebo is disputed in the scientific literature, with most studies only showing mild short-term effect (less than six weeks) on pain compared to placebo injections.
Transcranial direct current stimulation (tDCS) is a non-invasive technique allowing to stimulate areas of the brain in order to change the excitability of the neurons. When the negative electrode is applied on the motor cortex of the brain, it increases the excitability of the neurons in that area, which in turns inhibits the activity of the thalamus, an area of the brain linked with the perception of pain. Some studies have shown that tDCS can improve chronic pain of different origins, such as lower back pain, fibromyalgia, stroke, osteoarthritis, and post-operative pain.
We tested whether applying tDCS following a CSI would have more effect on patient's pain, function, and activity, than CSI alone.
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, Investigator, Outcomes Assessor)
盲法说明
Participants and assessors were blind to the assignment of the treatment vs placebo group, while there was no feasible way to conceal the control group.
Participants from the treatment and placebo group received the tDCS intervention by a care provider not involved in the recruitment, data collection or outcome assessment. The tDCS apparatus was out of sight of the participant for the duration of the treatment. Treatment patients received tDCS treatment for the whole duration of the planned intervention (20 minutes), while the device was only turned on for 30 seconds, then gradually turned off for the participants in the placebo group. This was done in order to mimic the initial sensation of tingling felt by participants in the treatment group.
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
- 否
入选标准
- •Shoulder pain for at least 9 months
- •Trial of conservative treatment prior to inclusion
- •Positive painful arc sign
- •At least one positive impingement test (Neer or Hawkin's impingement sign)
- •Written and oral comprehension of French and/or English
- •Exclusion Criteria specific to rotator cuff tendinopathy and CSI:
- •Traumatic origin
- •Diagnosis of a systemic inflammatory joint disease
- •Complete rotator cuff tear on physical examination or MRI
- •Diagnosis of acromio-clavicular syndrome
- •Presence of cervical nerve root pain or symptoms
- •Other confounding pathologies seen clinically or radiographically
- •History of previous fracture or surgery at the shoulder
- •Contraindication to CSI
- •CSI received in the last three months
- •Planned or ongoing pregnancy
- •Receiving worker's compensation or being involved in litigation relating to the shoulder pathology.
- •Inability to follow protocol instructions
- •Exclusion Criteria specific to tDCS and transcranial magnetic stimulation:
- •History of epilepsy or convulsions
- •Brain metallic implants or fragments
- •Brain lesions or tumors
- •Use of a pacemaker or ICD
- •Use of an intravenous medication pump
- •Severe cardiac disease, or recent cardiac event
- •Consumption of medications known to lower the seizure threshold
- •Alcoholism
- •Severe sleep deprivation
- •Eczema or skin lesions at the area of electrode application
排除标准
- 未提供
结局指标
主要结局
Western Ontario Rotator Cuff index (WORC)
时间窗: Two weeks following tDCS (four weeks after CSI)
The WORC is a health related quality of life questionnaire developed specifically to assess outcome in patients with rotator cuff disease. It includes 21 questions in the form of visual analog scales (VAS) covering five domains: physical symptoms, sports and recreation, work, quality of life, and emotional status. The final score can be reported over 100 points, with a higher score represents better function.
次要结局
- Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)(One week before the CSI, day of the CSI (just prior to the injection), two-weeks after CSI (just prior to tDCS), four weeks after CSI, eight weeks after CSI)
- Pain visual analog scale (pain VAS)(Filled every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after, with an additional week eight weeks following CSI.)
- Western Ontario Rotator Cuff index (WORC)(One week before the CSI, day of the CSI (just prior to the injection), two-weeks after CSI (just prior to tDCS),eight weeks after CSI (six weeks after tDCS))
- Shoulder Range of Motion (ROM)(One week before the CSI, day of the CSI (just prior to the injection), two-weeks after CSI (just prior to tDCS), four weeks after CSI)
- Shoulder strength(One week before the CSI, day of the CSI (just prior to the injection), two-weeks after CSI (just prior to tDCS), four weeks after CSI)
- Shoulder activity VAS(Filled every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after, with an additional week eight weeks following CSI.)
- Arm usage measured by actimetry(Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after.)
研究者
Samuel Larrivée
Principal Investigator
Université de Sherbrooke