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NCT Number: NCT06795932

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lab BioNR - UQAC

Saguenay, Quebec, G7H 2B1, Canada

Location status: Recruiting

Location contact

Émilie Bouchard, M.Sc. PhD candidate

CONTACT

[email protected]

581-882-0300

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tendon Vibration

Device

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

Other

Standardized exercise protocol, performed daily for 3 weeks, with a diary.

Primary outcomes

  1. Shoulder Pain And Disability Index

    Time frame: at baseline 1 and follow-up 1 : 2 months

    SPADI : Shoulder Pain And Disability Index Thirteen questions to quantify the level of difficulty, ranging from 0 to 10, based on pain and disability.

    Five questions assess pain (0 = no pain, 10= worst pain imaginable) and eight questions assess the level of difficulty in performing different tasks (0= no difficulty, 10=too difficult, need help).

  2. Quick Disability of the Hand, Arm and Shoulder

    Time frame: at baseline 1 and follow-up 1: 2 months

    QuickDASH : Quick Disability of the Hand, Arm and Shoulder Allowing the calculation of a percentage ratio from 14 questions, using a visual analogue scale from 1 (no difficulty) to 5 (incapacity), on the effects of pain on daily life activities, work, and sports, in addition to associated symptoms such as paresthesia and sleep disturbances.

  3. Questionnaire St-Antoine

    Time frame: at baseline 1 and follow-up 1: 2 months

    French version of McGill Pain Questionnaire. Subjectively assess the pain level with 16 questions on a scale from 0 (none) to 4 (extremely severe).

  4. Range of motion

    Time frame: at baseline 1 and follow-up 1: 2 months

    Measuring the active and passive range of motion with a goniometer.

  5. Standardized Kinesthetic Illusion Procedure

    Time frame: at baseline 1/2 and follow-up 1/2 : 2 months (+/- 2 weeks)

    Using the SKIP to evaluate:

    • Clarity: 0 = no illusion, 1 = vague, 2 = moderately clear, 3 = perfectly clear
    • Direction: using words
    • Speed/amplitude of illusion: using a visual analogue scale where participants mark a point on the line to represent the speed/amplitude (ranging between very slow/small to very fast/high)
  6. Active motor threshold

    Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)

    The active motor threshold represents the intensity of stimulation (%) required to elicit measurable motor evoked potentials.

  7. Amplitude of motor evoked potential

    Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)

    The measurement of the motor evoked potential amplitude (peak-to-peak) It corresponds to the amount of neurons stimulated at the central et peripheral levels, expressed in microvolts.

  8. Latency of motor evoked potential

    Time frame: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)

    The measurement of the motor evoked potential latency in miliseconds. It represent the conduction time from the application of the stimuli over the cortex to the target muscle.

Secondary outcomes

  1. Sociodemographic - age

    Time frame: at baseline 1 : 1 day

    Age of each participant, in months

  2. Sociodemographic - Sex

    Time frame: at baseline 1: 1 day

    Physiological sex

  3. Sociodemographic - Weight

    Time frame: at baseline 1: 1 day

    kilograms

  4. Sociodemographic - Height

    Time frame: at baseline 1: 1 day

    in meters

Study contacts

Contact information is provided by the study sponsor or research team.

Louis-David Beaulieu, PhD

CONTACT

[email protected]

418 545-5011 ext. 6109

Émilie Bouchard, M.Sc. PhD candidate

CONTACT

[email protected]

581-882-0300

Sponsors and collaborators

Lead sponsor

Université du Québec à Chicoutimi

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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