Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT06795932
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices
Sponsor:
Université du Québec à Chicoutimi
Organization:
Study Overview
Official Title:
Prise En Charge Des Atteintes Proprioceptives Chez Une Population Avec Capsulite Rétractile
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: