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Recruiting NCT06795932

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

◆ AI Clinical Summary

This study examines how the nervous system processes sensation and controls muscles in people with frozen shoulder (adhesive capsulitis) compared to people without this condition. Researchers will use a non-invasive brain stimulation technique called transcranial magnetic stimulation to measure these nervous system functions.

Key Objective: This trial aims to better understand the underlying nervous system changes in frozen shoulder, which could lead to improved non-invasive treatment approaches.

Who to Consider: People with adhesive capsulitis of the shoulder who are interested in contributing to research that may improve understanding and treatment of this condition should consider enrolling.

Trial Parameters

Condition Adhesive Capsulitis of the Shoulder
Sponsor Université du Québec à Chicoutimi
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-17
Completion 2027-04
Interventions
Tendon VibrationExercicesTendon vibration

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.

Eligibility Criteria

Inclusion Criteria: * 18 years old and over * Good general health * Adhesive capsulitis (experimental group) or * No shoulder pain (placebo group) Exclusion Criteria: * 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.

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