Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06795932

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

Led by Université du Québec à Chicoutimi · Updated on 2025-01-28

30

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old and over
  • Good general health
  • Diagnosis of adhesive capsulitis (experimental group) or no shoulder pain (placebo group)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Lab BioNR - UQAC

Saguenay, Quebec, Canada, G7H 2B1

Actively Recruiting

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Research Team

É

Émilie Bouchard, M.Sc. PhD candidate

CONTACT

L

Louis-David Beaulieu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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