Transcranial Direct Current Stimulation to Enhance Rehabilitation in Individuals With Rotator Cuff Tendinopathy

NCT03104218 | Completed DMC

• 1 other identifier: Jean-Sébastien Roy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial direct current stimulation (tDCS), an electrostimulation technique known to modulate the motor cortex excitability, has been shown to enhance the effects of rehabilitation in populations with neurological injuries. tDCS could similarly be effective in individuals with rotator cuff (RC) tendinopathy, as this pathology is also associated with pain and motor control deficits. For the treatment of RC tendinopathy, sensorimotor training is effective to reduce pain, increase function and enhance motor control of the shoulder. The addition of tDCS during sensorimotor training could enhance motor learning associated with sensorimotor training and thus improve treatment outcome. PURPOSE: To compare, in terms of symptoms, functional limitations and shoulder control, a group receiving a rehabilitation program centered on sensorimotor training combined with tDCS to a group receiving the same rehabilitation program combined with sham tDCS in individuals with RC tendinopathy. METHODS: Forty adults with RC tendinopathy will take part in the 4 evaluation sessions (0, 3, 6, 12 weeks) and a 6-week rehabilitation program. Outcome measures will be symptoms and functional limitations (Disability of the Arm, Shoulder and Hand and the Western Ontario Rotator Cuff index), as well as acromiohumeral distance (\[AHD\] ultrasonographic measurement at 0° and 60° of elevation arm). The rehabilitation program will include sensorimotor training, strengthening and education. tDCS will be apply during sensorimotor training on the motor cortex contralateral to the side of pain. A 2-way ANOVA will be used to analyse the effects of tDCS on the outcomes.

Conditions

Rotator Cuff Tendinopathy

Outcome Measures

Primary Outcomes (2)

• Change from Symptoms perceived at week 3,6 and 12.

  Change from Baseline Symptoms perceived at week 3,6 and 12 with DASH (Disability of the Arm, Shoulder and Hand; self-administered questionnaire)

  At week 3, 6, and 12, the self-administered DASH questionnaires will be administered.

• Change from Functional limitations perceived at week 3,6 and 12.

  Change from Functional limitations at week 3,6 and 12 with WORC (Western Ontario Rotator Cuff Index; self-administered questionnaire)

  At week 3, 6, and 12, the self-administered WORC questionnaire will be administered.

Secondary Outcomes (3)

• Change from US measurement of supraspinatus tendon at week 0 and 6.

  US measurement will be performed at week 0 and 6.

• Change from Corticospinal excitability of the infraspinatus (IS) muscle at day 1 before the first treatment and day 1 after the first treatment.

  Through first tDCS treatment of each participant.

• Change from US measurement of AHD at week 0 and 6.

  US measurement of AHD will be performed at week 0 and 6.

Study Arms (2)

tDCS group

EXPERIMENTAL

tDCS will be delivered using a direct current stimulator (constant current of 1.5 mA) via two 35cm2 (5 x 7 cm) saline-soaked surface sponge electrodes (parameters shown effective to enhance training). The center of the active electrode will be positioned over C3/C4 (international 10-20 EEG system; corresponding to the cortical representation of upper limb muscles), contralateral to the side of pain and the reference electrode over the contralateral supraorbital region. Current intensity will be ramped up (0-1.5 mA) and down (1.5-0 mA) over 15 seconds at the beginning and end of the 30 minutes stimulation period.

Other: tDCS group

Placebo group

SHAM COMPARATOR

The sham tDCS involves electrodes placed in an identical position to that used for active stimulation; however the stimulation will be turned on for 15 seconds and then off to provide participants with the initial "itching" sensation but without current for the remainder of the period. This procedure has been shown to effectively blind participants to the stimulation condition. The parameters on the tDCS will be set-up by a research assistant before each session. The treating physiotherapist will not have access to the control board of the tDCS.

Other: Placebo group

Interventions

tDCS group OTHER

Interventions: movement training, strengthening, patient education. tDCS will be delivered using a direct current stimulator (constant current of 1.5 mA) via two 35cm2 (5 x 7 cm) saline-soaked surface sponge electrodes (parameters shown effective to enhance training).40 The center of the active electrode will be positioned over C3/C4 (international 10-20 EEG system; corresponding to the cortical representation of upper limb muscles)57, contralateral to the side of pain and the reference electrode over the contralateral supraorbital region. Current intensity will be ramped up (0-1.5 mA) and down (1.5-0 mA) over 15 seconds at the beginning and end of the 30 minutes stimulation period.

tDCS group

Placebo group OTHER

Interventions: movement training, strengthening, patient education. The sham tDCS involves electrodes placed in an identical position to that used for active stimulation; however the stimulation will be turned on for 15 seconds and then off to provide participants with the initial "itching" sensation but without current for the remainder of the period. This procedure has been shown to effectively blind participants to the stimulation condition.

Placebo group

Eligibility Criteria

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

You may qualify if:

• painful arc of movement
• positive Neer or Kennedy-Hawkins tests
• pain on resisted isometric lateral rotation or abduction, or positive Jobe test. The diagnosis accuracy of the combination of these tests has been studied (sensitivity \& specificity ≥ 0.74)

You may not qualify if:

• fracture at the symptomatic upper limb;
• previous neck or shoulder surgery;
• shoulder pain reproduced during active neck movement;
• shoulder capsulitis;
• clinical signs of a full thickness RC tear;
• rheumatoid, inflammatory, or neurological diseases;
• behavioural or cognitive problems.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Center of Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, G1M2S8, Canada

Location

Related Publications (8)

• Roy JS, Moffet H, McFadyen BJ. Upper limb motor strategies in persons with and without shoulder impingement syndrome across different speeds of movement. Clin Biomech (Bristol). 2008 Dec;23(10):1227-36. doi: 10.1016/j.clinbiomech.2008.07.009. Epub 2008 Aug 30.

  PMID: 18757123 BACKGROUND

• Ngomo S, Mercier C, Bouyer LJ, Savoie A, Roy JS. Alterations in central motor representation increase over time in individuals with rotator cuff tendinopathy. Clin Neurophysiol. 2015 Feb;126(2):365-71. doi: 10.1016/j.clinph.2014.05.035. Epub 2014 Jun 21.

  PMID: 25043198 BACKGROUND

• Tsao H, Galea MP, Hodges PW. Driving plasticity in the motor cortex in recurrent low back pain. Eur J Pain. 2010 Sep;14(8):832-9. doi: 10.1016/j.ejpain.2010.01.001. Epub 2010 Feb 23.

  PMID: 20181504 BACKGROUND

• Desmeules F, Minville L, Riederer B, Cote CH, Fremont P. Acromio-humeral distance variation measured by ultrasonography and its association with the outcome of rehabilitation for shoulder impingement syndrome. Clin J Sport Med. 2004 Jul;14(4):197-205. doi: 10.1097/00042752-200407000-00002.

  PMID: 15273525 BACKGROUND

• Roy JS, Moffet H, Hebert LJ, Lirette R. Effect of motor control and strengthening exercises on shoulder function in persons with impingement syndrome: a single-subject study design. Man Ther. 2009 Apr;14(2):180-8. doi: 10.1016/j.math.2008.01.010. Epub 2008 Mar 20.

  PMID: 18358760 BACKGROUND

• Vaseghi B, Zoghi M, Jaberzadeh S. Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. Clin Neurophysiol. 2014 Sep;125(9):1847-58. doi: 10.1016/j.clinph.2014.01.020. Epub 2014 Feb 4.

  PMID: 24555922 BACKGROUND

• Feng WW, Bowden MG, Kautz S. Review of transcranial direct current stimulation in poststroke recovery. Top Stroke Rehabil. 2013 Jan-Feb;20(1):68-77. doi: 10.1310/tsr2001-68.

  PMID: 23340073 BACKGROUND

• Siebner HR, Lang N, Rizzo V, Nitsche MA, Paulus W, Lemon RN, Rothwell JC. Preconditioning of low-frequency repetitive transcranial magnetic stimulation with transcranial direct current stimulation: evidence for homeostatic plasticity in the human motor cortex. J Neurosci. 2004 Mar 31;24(13):3379-85. doi: 10.1523/JNEUROSCI.5316-03.2004.

  PMID: 15056717 BACKGROUND

Study Officials

• Jean-Sébastien Roy, Pht,PhD

  Center of Interdisciplinary Research in Rehabilitation and Social Integration, Quebec City, Laval University, Quebec City, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A randomisation list will be established prior to the initiation of the study using a random number generator. The randomisation list will be generated by an independent research assistant not involved in data collection. Allocation will be concealed in sealed and opaque envelopes that will be sequentially numbered. Randomisation will be stratified to ensure balance of the treatment groups with respect to sex. A blocked randomisation will also be used to make sure that two equal groups of 20 participants are obtained. Given that it is possible to blind the treating PT, the participants and the evaluators, a triple-blind design will be used. An independent research assistant from the CIRRIS will open the randomisation envelope indicating the participant's assignment. The research assistant will be blind to the baseline evaluation results. The research assistant will be the one who will set-up the parameters on the tDCS before treatment sessions with tDCS (real or sham tDCS).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This triple-blind (patients, therapist \& evaluator), parallel-group RCT will include four evaluation sessions over 3 months (baseline, week 3, week 6, 3-month) and 8 supervised physiotherapy treatments during a 6-week rehabilitation program (3 sessions the 1st week, 2 sessions the 2nd weeks, 3 session in the last 4 weeks). Thereafter, participants will be randomly assigned to one of two intervention groups, and then take part in their assigned 6-week intervention. At week 3, 6, and 12, the self-administered questionnaires will be re-administered, while US measurements will only be re-evaluated at week 6.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: April 7, 2017
• Study Start: January 11, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

CA (1)