Rotator Cuff Injuries Clinical Trial
Official title:
Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy
NCT number | NCT03967574 |
Other study ID # | 14-158 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 4, 2015 |
Est. completion date | March 16, 2016 |
Verified date | June 2019 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | March 16, 2016 |
Est. primary completion date | March 16, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Global rating of change scale (GRCS) | This form asks the participants to rate improvement in their symptoms on a scale with 15 levels, starting from "A very great deal worse", with a midpoint being "About the same" and ending with "A very great deal better". This questionnaire will be used to help validate accelerometry as an outcome measure in a secondary analysis. | Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS), eight weeks after CSI (six weeks after tDCS). | |
Other | Percentage of improvement | Participants will be asked verbally how much improvement, in percentage, they felt their shoulder improved since the CSI. | Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS). | |
Primary | Western Ontario Rotator Cuff index (WORC) | 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. | Two weeks following tDCS (four weeks after CSI) | |
Secondary | Western Ontario Rotator Cuff index (WORC) | 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. | 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) | |
Secondary | Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) | The QuickDASH is a health related quality of life questionnaire developed for pathologies affecting the arm, shoulder and hand. It consists of 11 questions in the form of Likert scales. The score can be reported on a scale of 0 to 100, with higher score representing worse outcome. | 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 | |
Secondary | Pain visual analog scale (pain VAS) | The participant will be asked to rank their pain for the last 24h on a VAS, with anchors being "no pain" on the left end, and "Extreme pain" on the right end. | 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. | |
Secondary | Shoulder Range of Motion (ROM) | 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. |
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 | |
Secondary | Shoulder strength | Using a hand-held dynamometer, shoulder strength will be measured in three planes: scapular plane with the thumb pointed down (Jobe test, or empty can test), external rotation with the arm adducted, internal rotation with the arm adducted | 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 | |
Secondary | Shoulder activity VAS | The participants will be asked to rank their estimated affected shoulder use for the last 24h using a VAS, with the left anchor being "Not at all" and the right anchor being "All the time". | 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. | |
Secondary | Arm usage measured by actimetry | An accelerometer developed at our institution (WIMU-GPS) will be worn at the wrist during the day for a total of five weeks. It will record acceleration, angular velocity, and magnetic field interactions in order to estimate upper extremity usage. At the time of initial ethical approval, the exact algorithm for upper extremity usage estimation was not decided. At the end of data collection, it was decided to use percentage of active time (time spent over a prespecified threshold), activity count, ratio of high intensity activities (activities in the highest 33% percentile of activity count), ratio of medium intensity activities (activities in the middle 33% percentile of activities) and ratio of low intensity activities (activities in the low 33% percentile of activity counts) | Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06070493 -
The Effects of Myofascial Release Technique
|
N/A | |
Completed |
NCT04541953 -
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
|
N/A | |
Completed |
NCT04944446 -
Myofascial Release in Shoulder Pathologies
|
N/A | |
Recruiting |
NCT06112444 -
Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index
|
||
Completed |
NCT04594408 -
Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery
|
Phase 4 | |
Active, not recruiting |
NCT04686396 -
Demineralized Bone Matrix Rotator Cuff Study
|
N/A | |
Recruiting |
NCT05988541 -
Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.
|
N/A | |
Completed |
NCT04470167 -
Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear
|
Phase 1/Phase 2 | |
Recruiting |
NCT05297305 -
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
|
N/A | |
Completed |
NCT02528084 -
The Effects of Yoga on Patients With Rotator Cuff Injuries
|
N/A | |
Recruiting |
NCT05011331 -
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome
|
N/A | |
Recruiting |
NCT04209504 -
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
|
||
Not yet recruiting |
NCT05906004 -
Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch
|
||
Completed |
NCT04952623 -
Online Education to Improve the Management of Rotator Cuff Related Shoulder Pain
|
N/A | |
Recruiting |
NCT05344898 -
Subscap Reverse Shoulder Arthroplasty
|
N/A | |
Recruiting |
NCT04175184 -
Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain
|
N/A | |
Terminated |
NCT05215600 -
Anaverseā¢ Glenoid System and Its Instrumentation
|
||
Recruiting |
NCT05822414 -
ESP vs STB for Pain and Diagraphragm Function for Shoulder Surgery
|
N/A | |
Completed |
NCT04833244 -
Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use
|
N/A | |
Completed |
NCT03982108 -
Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique
|
N/A |