Recruiting

Neurostimulation Devices

Sponsor:

Université du Québec à Chicoutimi

Code:

NCT06795932

Conditions

Adhesive Capsulitis of the Shoulder

Frozen Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tendon Vibration

Exercices

Tendon vibration

Study Details

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.

Conditions

Adhesive Capsulitis of the Shoulder

Frozen Shoulder

Study ID

NCT06795932

Start date

Oct 17, 2024

Status verified date

Nov, 2024

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Émilie Bouchard, M.Sc. PhD candidate

581-882-0300e4bouch@uqac.ca

Louis-David Beaulieu, PhD

418 545-5011ldbeauli@uqac.ca

Locations

Lab BioNR - UQAC

Recruiting

Saguenay, Quebec, Canada, G7H 2B1

Contacts

Émilie Bouchard, M.Sc. PhD candidate

581-882-0300e4bouch@uqac.ca

More Information

Sponsor

Université du Québec à Chicoutimi

Last update posted

Jan 28, 2025

Last verified

Nov, 2024

Keywords

  • Adhesive Capsulitis
  • Frozen shoulder
  • Tendon Vibration
  • Transcranial Magnetique Stimulation
  • Proprioception
  • Kinesthetic illusions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université du Québec à Chicoutimi on 2025-01-28.