Rotator Cuff TendinosisNCT03967574
Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy
A study testing Transcranial direct current stimulation in people with Rotator Cuff Tendinosis and Rotator Cuff Impingement Syndrome, run by Université de Sherbrooke.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinosis, Rotator Cuff Impingement Syndrome, Rotator Cuff Impingement
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2015to 16 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 29Show fewer
- 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
Who cannot join
None listed.
About this study
Official title: Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy
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.
Read the 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.
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Impingement Syndrome, Rotator Cuff Impingement, Rotator Cuff Injuries, Rotator Cuff Syndrome of Shoulder and Allied Disorders
- Being tested
- Transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, non invasive brain stimulation, tDCS, NIBS, subacromial corticosteroid injection
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called Anodal transcranial direct current stimulation, Non invasive brain 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.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | Participants received the full tDCS intervention for a total of 20 minutes, one time, two weeks following the CSI Receives: Device: Transcranial direct current stimulation |
| Sham tDCS | Sham comparator | 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. Receives: Device: Transcranial direct current stimulation |
| Control | No intervention | Participants received no further intervention two weeks following their CSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks following tDCS (four weeks after CSI)
Secondary outcomes (7)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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.
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.
Measured: 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
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
Measured: 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
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".
Measured: 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
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)
Measured: Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start4 Nov 2015
- Primary completion16 Mar 2016
- Study completion16 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TendinosisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants received a subacromial corticosteroid injection. Two weeks following the injection, participants were randomized into 3 groups: * Anodal transcranial direct current stimulation (treatment group) * Placebo tDCS (placebo group) * No further intervention (control group)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Responsible party
- Principal investigator, Samuel Larrivée, Université de Sherbrooke
- Investigators
- Patrick Boissy, PhD, Study director, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967574
- Sponsor's protocol ID
- 14-158
- Status last verified
- Jun 2019
- First submitted
- 26 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We will likely be sharing an spreadsheet containing anonymized IPD, including all outcome measures for each time point. The accelerometer data will however be summarized in a per-week average and standard deviation, as the data files are too large (\>4 Gb each) to be shared in a practical way. We also plan to share original study protocol, analysis plan, and participant consent forms. The data will be available for a total of 5 years after publication of the study results, and then destroyed as required by our research ethics board.
Publications
Larrivee S, Balg F, Leonard G, Bedard 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.
PubMed 33706729
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT03967574
- Acronym / sponsor ID
- 14-158
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Impingement Syndrome, Rotator Cuff Impingement, Rotator Cuff Injuries, Rotator Cuff Syndrome of Shoulder and Allied Disorders
- Keywords
- transcranial direct current stimulation, non invasive brain stimulation, tDCS, NIBS, subacromial corticosteroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants received a subacromial corticosteroid injection. Two weeks following the injection, participants were randomized into 3 groups: * Anodal transcranial direct current stimulation (treatment group) * Placebo tDCS (placebo group) * No further intervention (control group)
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: Transcranial direct current stimulationParticipants received the full tDCS intervention for a total of 20 minutes, one time, two weeks following the CSI |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulationThe 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. |
| Control | No intervention | –Participants received no further intervention two weeks following their CSI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationAlso: Anodal transcranial direct current stimulation, Non invasive brain stimulationThe 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. | Device | Real tDCS, Sham tDCS |
Primary outcome
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.
7 secondary outcomes
Western Ontario Rotator Cuff index (WORC)
Time frame: 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)
Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
Time frame: 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)
Time frame: 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.
Shoulder Range of Motion (ROM)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Derived from this study: PubMed 33706729Larrivee S, Balg F, Leonard G, Bedard 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.
- Individual participant dataSharing planned: Undecided. We will likely be sharing an spreadsheet containing anonymized IPD, including all outcome measures for each time point. The accelerometer data will however be summarized in a per-week average and standard deviation, as the data files are too large (>4 Gb each) to be shared in a practical way. We also plan to share original study protocol, analysis plan, and participant consent forms. The data will be available for a total of 5 years after publication of the study results, and then destroyed as required by our research ethics board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Boissy, PhD study director
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Rotator Cuff Tendinosis and Rotator Cuff Impingement Syndrome, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff index (WORC) (time frame: Two weeks following tDCS (four weeks after CSI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.