Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy
Keywords
Abstract
Description
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.
Dates
Last Verified: | 05/31/2019 |
First Submitted: | 05/25/2019 |
Estimated Enrollment Submitted: | 05/27/2019 |
First Posted: | 05/29/2019 |
Last Update Submitted: | 06/01/2019 |
Last Update Posted: | 06/03/2019 |
Actual Study Start Date: | 11/03/2015 |
Estimated Primary Completion Date: | 03/15/2016 |
Estimated Study Completion Date: | 03/15/2016 |
Condition or disease
Intervention/treatment
Device: Transcranial direct current stimulation
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Real tDCS Participants received the full tDCS intervention for a total of 20 minutes, one time, two weeks following the CSI | |
Sham Comparator: Sham tDCS The patients were set up in an identical way as with the real tDCS group, but only received active stimulation for 30 seconds, after which the current was gradually stopped. The participants continued wearing the electrodes until the end of the 20 minutes treatment. | |
No Intervention: Control Participants received no further intervention two weeks following their CSI |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Western Ontario Rotator Cuff index (WORC) [Two weeks following tDCS (four weeks after CSI)]
Secondary Outcome Measures
1. 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)]
2. 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]
3. 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.]
4. 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]
5. 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]
6. 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.]
7. 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.]
Other Outcome Measures
1. Global rating of change scale (GRCS) [Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS), eight weeks after CSI (six weeks after tDCS).]
2. Percentage of improvement [Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS).]