Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

NCT03967574 | Completed FDA Device

• 1 other identifier: 14-158
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks following tDCS (four weeks after CSI)

Secondary Outcomes (7)

• 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

Other Outcomes (2)

• Global rating of change scale (GRCS)

  Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS), eight weeks after CSI (six weeks after tDCS).

• Percentage of improvement

  Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS).

Study Arms (3)

Real tDCS

EXPERIMENTAL

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

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.

Device: Transcranial direct current stimulation

Control

NO INTERVENTION

Participants received no further intervention two weeks following their CSI

Interventions

Transcranial direct current stimulation 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.

Also known as: Anodal transcranial direct current stimulation, Non invasive brain stimulation

Real tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Shoulder pain for at least 9 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator

Related Publications (1)

• 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.

  PMID: 33706729 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Patrick Boissy, PhD

  Université de Sherbrooke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 30, 2019
• Study Start: November 4, 2015
• Primary Completion: March 16, 2016
• Study Completion: March 16, 2016
• Last Updated: June 4, 2019

Record last verified: 2019-06