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

NCT06795932 | Recruiting

• 1 other identifier: CER-UQAC : 2025-1773
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Sociodemographic - age

  at baseline 1 : 1 day

• Sociodemographic - Sex

  at baseline 1: 1 day

• Sociodemographic - Weight

  at baseline 1: 1 day

• Sociodemographic - Height

  at baseline 1: 1 day

Study Arms (2)

Tendon vibration and standardized exercise protocol

EXPERIMENTAL

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; Other: Exercices

Tendon vibration without kinesthetic illusion and standardized exercise protocol

SHAM COMPARATOR

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

Other: Exercices; Device: Tendon vibration

Interventions

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

Tendon vibration and standardized exercise protocol

Exercices OTHER

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

Tendon vibration and standardized exercise protocol; Tendon vibration without kinesthetic illusion and standardized exercise protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and over
• Good general health
• Adhesive capsulitis (experimental group) or
• No shoulder pain (placebo group)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Chicoutimi: lead

Study Sites (1)

Lab BioNR - UQAC

Saguenay, Quebec, G7H 2B1, Canada

RECRUITING

MeSH Terms

Conditions

Bursitis; Illusions

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Émilie Bouchard, M.Sc. PhD candidate

CONTACT

581-882-0300; e4bouch@uqac.ca

Louis-David Beaulieu, PhD

CONTACT

418 545-5011; ldbeauli@uqac.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded randomized controlled trial

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: January 28, 2025
• Study Start: October 17, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 28, 2025

Record last verified: 2024-11

Locations

CA (1)