Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices

Официальное название

Prise En Charge Des Atteintes Proprioceptives Chez Une Population Avec Capsulite Rétractile

Обзор

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.

Вмешательства

• Устройство Tendon Vibration
  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
• Другое Exercices
  Standardized exercise protocol, performed daily for 3 weeks, with a diary.
• Устройство Tendon vibration
  Tendon vibration will not induce kinesthetic illusions, since it will be applied 40 Hz and 1 mm of amplitude for 10 seconds. Two interventions per week, for three weeks. Total : 6 interventions

Первичные конечные точки

• Shoulder Pain And Disability Index [Срок оценки: at baseline 1 and follow-up 1 : 2 months]
• Quick Disability of the Hand, Arm and Shoulder [Срок оценки: at baseline 1 and follow-up 1: 2 months]
• Questionnaire St-Antoine [Срок оценки: at baseline 1 and follow-up 1: 2 months]
• Range of motion [Срок оценки: at baseline 1 and follow-up 1: 2 months]
• Standardized Kinesthetic Illusion Procedure [Срок оценки: at baseline 1/2 and follow-up 1/2 : 2 months (+/- 2 weeks)]
• Active motor threshold [Срок оценки: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)]
• Amplitude of motor evoked potential [Срок оценки: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)]
• Latency of motor evoked potential [Срок оценки: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)]

Вторичные конечные точки (4)

• Sociodemographic - age [Срок оценки: at baseline 1 : 1 day]
• Sociodemographic - Sex [Срок оценки: at baseline 1: 1 day]
• Sociodemographic - Weight [Срок оценки: at baseline 1: 1 day]
• Sociodemographic - Height [Срок оценки: at baseline 1: 1 day]

Критерии участия

Критерии включения

• 18 years old and over
• Good general health
• Adhesive capsulitis (experimental group) or
• No shoulder pain (placebo group)

Критерии исключения

• Cognitive disorders;
• Any neurological disease/injury affecting the upper limbs;
• History or diagnosis of muscle, tendon, or capsular tear;
• Shoulder surgery/prosthesis;
• Pregnant woman;
• Presence of metal in the skull or jaw;
• History of epilepsy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Lab BioNR - UQAC — Saguenay

Идентификаторы

NCT: NCT06795932 · CER-UQAC : 2025-1773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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