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Recruiting NCT06795932

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

No phase Interventional Adhesive Capsulitis of the Shoulder Frozen Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tendon Vibration, Exercices, Tendon vibration.
Who it may be relevant to
Registry conditions: Adhesive Capsulitis of the Shoulder, Frozen Shoulder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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
  • Other Exercices
    Standardized exercise protocol, performed daily for 3 weeks, with a diary.
  • Device 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

Primary outcome measures

  • Shoulder Pain And Disability Index [Time frame: at baseline 1 and follow-up 1 : 2 months]
  • Quick Disability of the Hand, Arm and Shoulder [Time frame: at baseline 1 and follow-up 1: 2 months]
  • Questionnaire St-Antoine [Time frame: at baseline 1 and follow-up 1: 2 months]
  • Range of motion [Time frame: at baseline 1 and follow-up 1: 2 months]
  • Standardized Kinesthetic Illusion Procedure [Time frame: at baseline 1/2 and follow-up 1/2 : 2 months (+/- 2 weeks)]
  • Active motor threshold [Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)]
  • Amplitude of motor evoked potential [Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)]
  • Latency of motor evoked potential [Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)]
Secondary outcome measures (4)
  • Sociodemographic - age [Time frame: at baseline 1 : 1 day]
  • Sociodemographic - Sex [Time frame: at baseline 1: 1 day]
  • Sociodemographic - Weight [Time frame: at baseline 1: 1 day]
  • Sociodemographic - Height [Time frame: at baseline 1: 1 day]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Lab BioNR - UQAC — Saguenay

Identifiers

NCT: NCT06795932 · CER-UQAC : 2025-1773

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗