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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frozen Shoulder; Adhesive Capsulitis of the Shoulder
• Intervention / Treatment: Device: Tendon Vibration; Other: Exercices; Device: Tendon vibration

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Émilie Bouchard, M.Sc. PhD candidate; Phone Number: 581-882-0300; Email: e4bouch@uqac.ca
• Study Contact Backup: Name: Louis-David Beaulieu, PhD; Phone Number: 6109 418 545-5011; Email: ldbeauli@uqac.ca

Study Locations

• Canada
  • Quebec
    • Saguenay, Quebec, Canada, G7H 2B1
      • Recruiting
      • Lab BioNR - UQAC
      • Contact: Émilie Bouchard, M.Sc. PhD candidate; Phone Number: 581-882-0300; Email: e4bouch@uqac.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain And Disability Index	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).	at baseline 1 and follow-up 1 : 2 months
Quick Disability of the Hand, Arm and Shoulder	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.	at baseline 1 and follow-up 1: 2 months
Questionnaire St-Antoine	French version of McGill Pain Questionnaire. Subjectively assess the pain level with 16 questions on a scale from 0 (none) to 4 (extremely severe).	at baseline 1 and follow-up 1: 2 months
Range of motion	Measuring the active and passive range of motion with a goniometer.	at baseline 1 and follow-up 1: 2 months
Standardized Kinesthetic Illusion Procedure	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)	at baseline 1/2 and follow-up 1/2 : 2 months (+/- 2 weeks)
Active motor threshold	The active motor threshold represents the intensity of stimulation (%) required to elicit measurable motor evoked potentials.	at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
Amplitude of motor evoked potential	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.	at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
Latency of motor evoked potential	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.	at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic - age	Age of each participant, in months	at baseline 1 : 1 day
Sociodemographic - Sex	Physiological sex	at baseline 1: 1 day
Sociodemographic - Weight	kilograms	at baseline 1: 1 day
Sociodemographic - Height	in meters	at baseline 1: 1 day

Collaborators and Investigators

• Sponsor: Université du Québec à Chicoutimi

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Proprioception; Adhesive Capsulitis; Frozen shoulder; Tendon Vibration; Transcranial Magnetique Stimulation; Kinesthetic illusions
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis
• Other Study ID Numbers: CER-UQAC : 2025-1773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No