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

Not Applicable

Recruiting

• Conditions: Adhesive Capsulitis of the Shoulder; Frozen Shoulder

• Registration Number: NCT06795932
• Lead Sponsor: Université du Québec à Chicoutimi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-17
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder Pain And Disability Index	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).
Quick Disability of the Hand, Arm and Shoulder	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.
Questionnaire St-Antoine	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).
Range of motion	at baseline 1 and follow-up 1: 2 months	Measuring the active and passive range of motion with a goniometer.
Standardized Kinesthetic Illusion Procedure	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)
Active motor threshold	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.
Amplitude of motor evoked potential	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.
Latency of motor evoked potential	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 Outcome Measures

Name	Time	Method
Sociodemographic - age	at baseline 1 : 1 day	Age of each participant, in months
Sociodemographic - Sex	at baseline 1: 1 day	Physiological sex
Sociodemographic - Weight	at baseline 1: 1 day	kilograms
Sociodemographic - Height	at baseline 1: 1 day	in meters

Trial Locations

Locations (1)

Lab BioNR - UQAC; 🇨🇦 Saguenay, Quebec, Canada