Clinical trial NCT06795932: Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices
Official title: Prise En Charge Des Atteintes Proprioceptives Chez Une Population Avec Capsulite Rétractile
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis of the Shoulder
Frozen Shoulder
Keywords: Adhesive Capsulitis
Frozen shoulder
Tendon Vibration
Transcranial Magnetique Stimulation
Proprioception
Kinesthetic illusions
Lead sponsor: Université du Québec à Chicoutimi
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized controlled trial
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Shoulder Pain And Disability Index
timeFrame: at baseline 1 and follow-up 1 : 2 months
measure: Quick Disability of the Hand, Arm and Shoulder
timeFrame: at baseline 1 and follow-up 1: 2 months
measure: Questionnaire St-Antoine
timeFrame: at baseline 1 and follow-up 1: 2 months
measure: Range of motion
timeFrame: at baseline 1 and follow-up 1: 2 months
measure: Standardized Kinesthetic Illusion Procedure
timeFrame: at baseline 1/2 and follow-up 1/2 : 2 months (+/- 2 weeks)
measure: Active motor threshold
timeFrame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
measure: Amplitude of motor evoked potential
timeFrame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
measure: Latency of motor evoked potential
timeFrame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
Secondary outcomes:
measure: Sociodemographic - age
timeFrame: at baseline 1 : 1 day
measure: Sociodemographic - Sex
timeFrame: at baseline 1: 1 day
measure: Sociodemographic - Weight
timeFrame: at baseline 1: 1 day
measure: Sociodemographic - Height
timeFrame: at baseline 1: 1 day
Other outcomes:
Locations:
city: Saguenay
country: Canada
facility: Lab BioNR - UQAC
state: Quebec
Study officials:
References: