Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

Université de Sherbrooke

Status: Completed

Conditions: Rotator Cuff Impingement; Rotator Cuff Tendinosis; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Rotator Cuff Impingement Syndrome; Rotator Cuff Injuries

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03967574

14-158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 3 patient groups

Real tDCS

Experimental group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

Sham tDCS

Sham Comparator group

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.

Treatment:

Device: Transcranial direct current stimulation

Control

No Intervention group

Description:

Participants received no further intervention two weeks following their CSI