Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices
NCT ID: NCT06795932
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-17
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tendon vibration and standardized exercise protocol
Six interventions inducing kinesthetic illusions (20 minutes, 1 illusion/minute).
Two interventions per week, for three weeks. Accompanied by a daily exercise protocol.
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
Exercices
Standardized exercise protocol, performed daily for 3 weeks, with a diary.
Tendon vibration without kinesthetic illusion and standardized exercise protocol
Six interventions not inducing kinesthetic illusions (20 minutes) Two interventions per week, for three weeks. Accompanied by a daily exercise protocol.
Exercices
Standardized exercise protocol, performed daily for 3 weeks, with a diary.
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
Interventions
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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
Exercices
Standardized exercise protocol, performed daily for 3 weeks, with a diary.
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
Eligibility Criteria
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Inclusion Criteria
* Good general health
* Adhesive capsulitis (experimental group) or
* No shoulder pain (placebo group)
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Université du Québec à Chicoutimi
OTHER
Responsible Party
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Locations
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Lab BioNR - UQAC
Saguenay, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CER-UQAC : 2025-1773
Identifier Type: -
Identifier Source: org_study_id
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