Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

NCT ID: NCT03967574

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-04
• Study Completion Date: 2016-03-16

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real tDCS

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

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

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.

Sham tDCS

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.

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

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.

Control

Participants received no further intervention two weeks following their CSI

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcranial direct current 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.

Intervention Type: DEVICE

Other Intervention Names

Anodal transcranial direct current stimulation; Non invasive brain stimulation

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Samuel Larrivée

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Boissy, PhD

Role: STUDY_DIRECTOR

Université de Sherbrooke

References

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.

Reference Type: DERIVED

PMID: 33706729 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

14-158

Identifier Type: -

Identifier Source: org_study_id