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Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinosis, Rotator Cuff Impingement Syndrome, Rotator Cuff Impingement

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinosis focused on measuring transcranial direct current stimulation, non invasive brain stimulation, tDCS, NIBS, subacromial corticosteroid injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Real tDCS

    Sham tDCS

    Control

    Arm Description

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

    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.

    Participants received no further intervention two weeks following their CSI

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
    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.
    Pain visual analog scale (pain VAS)
    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.
    Shoulder Range of Motion (ROM)
    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.
    Shoulder strength
    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
    Shoulder activity VAS
    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".
    Arm usage measured by actimetry
    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)

    Full Information

    First Posted
    May 26, 2019
    Last Updated
    June 2, 2019
    Sponsor
    Université de Sherbrooke
    Collaborators
    Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03967574
    Brief Title
    Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy
    Official Title
    Characterization and Temporal Evaluation of the Effects of Subacromial Corticosteroid Injections and Trans-cranial Direct Current Stimulation in Rotator Cuff Tendinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 4, 2015 (Actual)
    Primary Completion Date
    March 16, 2016 (Actual)
    Study Completion Date
    March 16, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université de Sherbrooke
    Collaborators
    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Masking
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Real tDCS
    Arm Type
    Experimental
    Arm Description
    Participants received the full tDCS intervention for a total of 20 minutes, one time, two weeks following the CSI
    Arm Title
    Sham tDCS
    Arm Type
    Sham Comparator
    Arm 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 Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants received no further intervention two weeks following their CSI
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial direct current stimulation
    Other Intervention Name(s)
    Anodal transcranial direct current stimulation, Non invasive brain stimulation
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Western Ontario Rotator Cuff index (WORC)
    Description
    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.
    Time Frame
    Two weeks following tDCS (four weeks after CSI)
    Secondary Outcome Measure Information:
    Title
    Western Ontario Rotator Cuff index (WORC)
    Description
    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.
    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)
    Title
    Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
    Description
    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.
    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
    Title
    Pain visual analog scale (pain VAS)
    Description
    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.
    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.
    Title
    Shoulder Range of Motion (ROM)
    Description
    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.
    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
    Title
    Shoulder strength
    Description
    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
    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
    Title
    Shoulder activity VAS
    Description
    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".
    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.
    Title
    Arm usage measured by actimetry
    Description
    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)
    Time Frame
    Worn every day, but it will be averaged for every week, starting one week before the CSI and ending four weeks after.
    Other Pre-specified Outcome Measures:
    Title
    Global rating of change scale (GRCS)
    Description
    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.
    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).
    Title
    Percentage of improvement
    Description
    Participants will be asked verbally how much improvement, in percentage, they felt their shoulder improved since the CSI.
    Time Frame
    Two week follow the CSI (prior to tDCS), four weeks following CSI (two weeks after tDCS).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick Boissy, PhD
    Organizational Affiliation
    Université de Sherbrooke
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    We will likely be sharing an spreadsheet containing anonymized IPD, including all outcome measures for each time point. The accelerometer data will however be summarized in a per-week average and standard deviation, as the data files are too large (>4 Gb each) to be shared in a practical way. We also plan to share original study protocol, analysis plan, and participant consent forms. The data will be available for a total of 5 years after publication of the study results, and then destroyed as required by our research ethics board.
    Citations:
    PubMed Identifier
    33706729
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

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