Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy

Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

Sponsors

Lead sponsor: Université de Sherbrooke

Collaborator: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Source Université de Sherbrooke
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.

Overall Status Completed
Start Date November 4, 2015
Completion Date March 16, 2016
Primary Completion Date March 16, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Western Ontario Rotator Cuff index (WORC) Two weeks following tDCS (four weeks after CSI)
Secondary Outcome
Measure Time Frame
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)
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
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.
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
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
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.
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.
Enrollment 38
Condition
Intervention

Intervention type: Device

Intervention name: Transcranial direct current stimulation

Description: 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.

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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Patrick Boissy, PhD Study Director Université de Sherbrooke
Verification Date

June 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Université de Sherbrooke

Investigator full name: Samuel Larrivée

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Real tDCS

Arm group type: Experimental

Description: Participants received the full tDCS intervention for a total of 20 minutes, one time, two weeks following the CSI

Arm group label: Sham tDCS

Arm group type: Sham Comparator

Description: 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.

Arm group label: Control

Arm group type: No Intervention

Description: Participants received no further intervention two weeks following their CSI

Patient Data Undecided
Study Design Info

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:
Anodal transcranial direct current stimulation (treatment group)
Placebo tDCS (placebo group)
No further intervention (control group)

Primary purpose: Treatment

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.

Source: ClinicalTrials.gov