Clinical trial NCT03967574: Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy
Official title: Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
First posted: 2019-05-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Western Ontario Rotator Cuff index (WORC)
timeFrame: Two weeks following tDCS (four weeks after CSI)
Secondary outcomes:
measure: Western Ontario Rotator Cuff index (WORC)
timeFrame: 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)
measure: Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
timeFrame: 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
measure: Pain visual analog scale (pain VAS)
timeFrame: 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.
measure: Shoulder Range of Motion (ROM)
timeFrame: 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
measure: Shoulder strength
timeFrame: 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
measure: Shoulder activity VAS
timeFrame: 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.
measure: Arm usage measured by actimetry
timeFrame: Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after.
Other outcomes:
measure: Global rating of change scale (GRCS)
timeFrame: Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS), eight weeks after CSI (six weeks after tDCS).
measure: Percentage of improvement
timeFrame: Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS).
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Patrick Boissy, PhD
role: STUDY_DIRECTOR
References:
citation: 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.