Condition or disease | Intervention/treatment | Phase |
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Rotator Cuff Tendinosis Rotator Cuff Impingement Syndrome Rotator Cuff Impingement Rotator Cuff Injuries Rotator Cuff Syndrome of Shoulder and Allied Disorders | Device: Transcranial direct current stimulation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | All participants received a subacromial corticosteroid injection. Two weeks following the injection, participants were randomized into 3 groups:
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Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy |
Actual Study Start Date : | November 4, 2015 |
Actual Primary Completion Date : | March 16, 2016 |
Actual Study Completion Date : | March 16, 2016 |
Arm | Intervention/treatment |
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Experimental: Real tDCS
Participants received the full tDCS intervention for a total of 20 minutes, one time, two weeks following the CSI
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Device: Transcranial direct current stimulation
The tDCS anode was applied on the primary motor cortex area responsible for the control of the rotator cuff, as determined using transcranial magnetic stimulation and surface electromyography. The cathode was applied on the contralateral forehead, just above the eyebrow. The electrodes were soaked in saline solution to improve conductivity and the montage was secured with rubber bands and adhesive tape. The tDCS device (Soterix Medical 1x1 tDCS device) was then gradually turned to an intensity of 2mA. This stimulation was continued for a total of 20 minutes, after which it was gradually stopped. Other Names:
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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.
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Device: Transcranial direct current stimulation
The tDCS anode was applied on the primary motor cortex area responsible for the control of the rotator cuff, as determined using transcranial magnetic stimulation and surface electromyography. The cathode was applied on the contralateral forehead, just above the eyebrow. The electrodes were soaked in saline solution to improve conductivity and the montage was secured with rubber bands and adhesive tape. The tDCS device (Soterix Medical 1x1 tDCS device) was then gradually turned to an intensity of 2mA. This stimulation was continued for a total of 20 minutes, after which it was gradually stopped. Other Names:
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No Intervention: Control
Participants received no further intervention two weeks following their CSI
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Shoulder ROM will be measured using a goniometer and reported in degrees in six different planes: abduction, flexion, scapular elevation (scaption), external rotation with the arm at the side, external rotation with the arm abducted 90 degrees and internal rotation with the arm abducted 90 degree.
Additionally, internal rotation will also be measured visually with the maximal spinal level reached by the thumb with the hand at the back.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria specific to rotator cuff tendinopathy and CSI:
Exclusion Criteria specific to tDCS and transcranial magnetic stimulation:
Study Director: | Patrick Boissy, PhD | Université de Sherbrooke |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 26, 2019 | ||||||||
First Posted Date ICMJE | May 30, 2019 | ||||||||
Last Update Posted Date | June 4, 2019 | ||||||||
Actual Study Start Date ICMJE | November 4, 2015 | ||||||||
Actual Primary Completion Date | March 16, 2016 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Western Ontario Rotator Cuff index (WORC) [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy | ||||||||
Official Title ICMJE | Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy | ||||||||
Brief Summary | 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. | ||||||||
Detailed 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: All participants received a subacromial corticosteroid injection. Two weeks following the injection, participants were randomized into 3 groups:
Masking Description: 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. |
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Condition ICMJE |
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Intervention ICMJE | Device: Transcranial direct current stimulation
The tDCS anode was applied on the primary motor cortex area responsible for the control of the rotator cuff, as determined using transcranial magnetic stimulation and surface electromyography. The cathode was applied on the contralateral forehead, just above the eyebrow. The electrodes were soaked in saline solution to improve conductivity and the montage was secured with rubber bands and adhesive tape. The tDCS device (Soterix Medical 1x1 tDCS device) was then gradually turned to an intensity of 2mA. This stimulation was continued for a total of 20 minutes, after which it was gradually stopped. Other Names:
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Study Arms ICMJE |
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Publications * | Larrivée S, Balg F, Léonard G, Bédard S, Tousignant M, Boissy P. Transcranial direct current stimulation (a-tCDS) after subacromial injections in patients with subacromial pain syndrome: a randomized controlled pilot study. BMC Musculoskelet Disord. 2021 Mar 11;22(1):265. doi: 10.1186/s12891-021-04139-2. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
38 | ||||||||
Original Actual Enrollment ICMJE | Same as current | ||||||||
Actual Study Completion Date ICMJE | March 16, 2016 | ||||||||
Actual Primary Completion Date | March 16, 2016 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria specific to rotator cuff tendinopathy and CSI:
Exclusion Criteria specific to tDCS and transcranial magnetic stimulation:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03967574 | ||||||||
Other Study ID Numbers ICMJE | 14-158 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Samuel Larrivée, Université de Sherbrooke | ||||||||
Study Sponsor ICMJE | Université de Sherbrooke | ||||||||
Collaborators ICMJE | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | ||||||||
Investigators ICMJE |
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PRS Account | Université de Sherbrooke | ||||||||
Verification Date | June 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |