Lab BioNR - UQAC
Saguenay, Quebec, G7H 2B1, Canada
Location status: Recruiting
NCT Number: NCT06795932
The goal of this randomized controlled trial is to compare the integrity of somatosensory processing with transcranial magnetique stimulation (TMS) and corticospinal excitability of the affected shoulder in individuals with adhesive capsulitis versus healthy controls.
The secondary objective is to compare the clinical and neurophysiological effects of an intervention using tendon vibration (VIB) to induced kinesthetic illusions. This will involve comparing two groups: one receiving a real intervention versus a placebo intervention protocol, both coupled with standardized exercises in individuals with capsulitis. The hypotheses are that the proprioceptive processing and corticospinal excitability are impaired in the presence of capsulitis, and that the VIB + exercises intervention will result in greater improvements than the placebo VIB + exercises.
To goal is to establish the first empirical foundations for understanding adhesive capsulitis, using cutting-edge neurophysiological investigation technologies.
TMS will be used to explore the presence of maladaptive plasticity in motor networks by assessing the excitability and integrity of the primary motor cortex (M1) and the corticospinal tract.
Recruitement:
30 healthy participants and 30 participants with a diagnosis of adhesive capsulitis will undergo 2 baselines assesments, 6 interventions with tendon vibration and 2 follow-up evaluation. Participants will be age- and sex-matched.
Baseline and follw-up include:
* Questionnaires : SPADI, QuickDASH, French version of the Mcgill Pain Questionnaire; * Active and passive range of motion; * Ultrasound for diagnosing capsulitis.
Comparison parameters:
* active motor threshold (aMT) * Motor evoked potential (MEP) latency and amplitude * Standardized kinesthetic illusion procedure (SKIP) : direction of illusion, clearness, amplitude/speed.
Interventions :
* 2 baselines including all questionnaires, ultrasound, active and passive range of motion, TMS procedure and SKIP; * 2 VIB interventions per week, for 3 weeks
* Real VIB : 80Hz of vibration to induce kinesthetic illusions, * Placebo VIB : 40Hz of vibration that does not induce kinesthetic illusions * 2 follow-up including all questionnaires, ultrasound, active and passive range of motion, TMS procedure and SKIP.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Saguenay, Quebec, G7H 2B1, Canada
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vibration can create kinesthetic illusions when applied at some modalities. The vibration will be put at 80 Hz and 1 mm of amplitude for 10 seconds to create 1 illusion/minute, during 20 minutes.
Two interventions per week, for three weeks. Total : 6 interventions
Standardized exercise protocol, performed daily for 3 weeks, with a diary.
Time frame: at baseline 1 and follow-up 1 : 2 months
SPADI : Shoulder Pain And Disability Index Thirteen questions to quantify the level of difficulty, ranging from 0 to 10, based on pain and disability.
Five questions assess pain (0 = no pain, 10= worst pain imaginable) and eight questions assess the level of difficulty in performing different tasks (0= no difficulty, 10=too difficult, need help).
Time frame: at baseline 1 and follow-up 1: 2 months
QuickDASH : Quick Disability of the Hand, Arm and Shoulder Allowing the calculation of a percentage ratio from 14 questions, using a visual analogue scale from 1 (no difficulty) to 5 (incapacity), on the effects of pain on daily life activities, work, and sports, in addition to associated symptoms such as paresthesia and sleep disturbances.
Time frame: at baseline 1 and follow-up 1: 2 months
French version of McGill Pain Questionnaire. Subjectively assess the pain level with 16 questions on a scale from 0 (none) to 4 (extremely severe).
Time frame: at baseline 1 and follow-up 1: 2 months
Measuring the active and passive range of motion with a goniometer.
Time frame: at baseline 1/2 and follow-up 1/2 : 2 months (+/- 2 weeks)
Using the SKIP to evaluate:
Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
The active motor threshold represents the intensity of stimulation (%) required to elicit measurable motor evoked potentials.
Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
The measurement of the motor evoked potential amplitude (peak-to-peak) It corresponds to the amount of neurons stimulated at the central et peripheral levels, expressed in microvolts.
Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
The measurement of the motor evoked potential latency in miliseconds. It represent the conduction time from the application of the stimuli over the cortex to the target muscle.
Time frame: at baseline 1 : 1 day
Age of each participant, in months
Time frame: at baseline 1: 1 day
Physiological sex
Time frame: at baseline 1: 1 day
kilograms
Time frame: at baseline 1: 1 day
in meters
Contact information is provided by the study sponsor or research team.
Louis-David Beaulieu, PhD
CONTACT
418 545-5011 ext. 6109
Émilie Bouchard, M.Sc. PhD candidate
CONTACT
Université du Québec à Chicoutimi
Other
Prise En Charge Des Atteintes Proprioceptives Chez Une Population Avec Capsulite Rétractile
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