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

Université du Québec à Chicoutimi

Status: Enrolling

Conditions: Adhesive Capsulitis of the Shoulder; Frozen Shoulder

Treatments: Device: Tendon vibration; Other: Exercices; Device: Tendon Vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT06795932

CER-UQAC : 2025-1773

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Tendon vibration and standardized exercise protocol

Experimental group

Description:

Six interventions inducing kinesthetic illusions (20 minutes, 1 illusion/minute). Two interventions per week, for three weeks. Accompanied by a daily exercise protocol.

Treatment:

Device: Tendon Vibration

Other: Exercices

Tendon vibration without kinesthetic illusion and standardized exercise protocol

Sham Comparator group

Description:

Six interventions not inducing kinesthetic illusions (20 minutes) Two interventions per week, for three weeks. Accompanied by a daily exercise protocol.

Treatment:

Other: Exercices

Device: Tendon vibration