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Completed

NCT Number: NCT03967574

Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

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.

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Key information

Conditions

Rotator Cuff Tendinosis Joint Diseases Musculoskeletal Diseases Rotator Cuff Impingement Rotator Cuff Impingement Syndrome Rotator Cuff Injuries Rotator Cuff Syndrome of Shoulder and Allied Disorders Rupture Shoulder Impingement Syndrome Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Anodal transcranial direct current stimulation, Non invasive brain stimulation

Primary outcomes

  1. Western Ontario Rotator Cuff index (WORC)

    Time frame: Two weeks following tDCS (four weeks after CSI)

    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.

Secondary outcomes

  1. Western Ontario Rotator Cuff index (WORC)

    Time frame: 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)

    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.

  2. Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)

    Time frame: 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

    The QuickDASH is a health related quality of life questionnaire developed for pathologies affecting the arm, shoulder and hand. It consists of 11 questions in the form of Likert scales. The score can be reported on a scale of 0 to 100, with higher score representing worse outcome.

  3. Pain visual analog scale (pain VAS)

    Time frame: 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.

    The participant will be asked to rank their pain for the last 24h on a VAS, with anchors being "no pain" on the left end, and "Extreme pain" on the right end.

  4. Shoulder Range of Motion (ROM)

    Time frame: 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 ROM will be measured using a goniometer and reported in degrees in six different planes: abduction, flexion, scapular elevation (scaption), external rotation with the arm at the side, external rotation with the arm abducted 90 degrees and internal rotation with the arm abducted 90 degree.

    Additionally, internal rotation will also be measured visually with the maximal spinal level reached by the thumb with the hand at the back.

  5. Shoulder strength

    Time frame: 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

    Using a hand-held dynamometer, shoulder strength will be measured in three planes: scapular plane with the thumb pointed down (Jobe test, or empty can test), external rotation with the arm adducted, internal rotation with the arm adducted

  6. Shoulder activity VAS

    Time frame: 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.

    The participants will be asked to rank their estimated affected shoulder use for the last 24h using a VAS, with the left anchor being "Not at all" and the right anchor being "All the time".

  7. Arm usage measured by actimetry

    Time frame: Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after.

    An accelerometer developed at our institution (WIMU-GPS) will be worn at the wrist during the day for a total of five weeks. It will record acceleration, angular velocity, and magnetic field interactions in order to estimate upper extremity usage. At the time of initial ethical approval, the exact algorithm for upper extremity usage estimation was not decided. At the end of data collection, it was decided to use percentage of active time (time spent over a prespecified threshold), activity count, ratio of high intensity activities (activities in the highest 33% percentile of activity count), ratio of medium intensity activities (activities in the middle 33% percentile of activities) and ratio of low intensity activities (activities in the low 33% percentile of activity counts)

Other outcomes

  1. Global rating of change scale (GRCS)

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

    This form asks the participants to rate improvement in their symptoms on a scale with 15 levels, starting from "A very great deal worse", with a midpoint being "About the same" and ending with "A very great deal better". This questionnaire will be used to help validate accelerometry as an outcome measure in a secondary analysis.

  2. Percentage of improvement

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

    Participants will be asked verbally how much improvement, in percentage, they felt their shoulder improved since the CSI.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 30, 2019
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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