Adhesive Capsulitis of the ShoulderNCT06795932
Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices
A study testing Tendon Vibration and Exercices in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by Université du Québec à Chicoutimi at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder, Frozen Shoulder
- What is being tested?
- Tendon Vibration and Exercices
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and over
- Good general health
- Adhesive capsulitis (experimental group) or
- No shoulder pain (placebo group)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Lab BioNR - UQAC
Saguenay, Quebec, G7H 2B1
Émilie Bouchard, M.Sc. PhD candidate, 581-882-0300, e4bouch@uqac.ca
About this study
Official title: 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.
Read more
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.
- Being tested
- Tendon Vibration, Exercices
- Keywords
- Adhesive Capsulitis, Frozen shoulder, Tendon Vibration, Transcranial Magnetique Stimulation, Proprioception, Kinesthetic illusions
- Medical subject headings
- Bursitis, Illusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon VibrationDevice
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
ExercicesOther
Standardized exercise protocol, performed daily for 3 weeks, with a diary.
Tendon vibrationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercices; Device: Tendon vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: at baseline 1 and follow-up 1: 2 months
Range of motion
Measuring the active and passive range of motion with a goniometer.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline 1-2 and follow-up 1-2: 2 months (+/- 2 weeks)
Secondary outcomes (4)
Sociodemographic - age
Age of each participant, in months
Measured: at baseline 1 : 1 day
Sociodemographic - Sex
Physiological sex
Measured: at baseline 1: 1 day
Sociodemographic - Weight
kilograms
Measured: at baseline 1: 1 day
Sociodemographic - Height
in meters
Measured: at baseline 1: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start17 Oct 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Chicoutimi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795932
- Sponsor's protocol ID
- CER-UQAC : 2025-1773
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prise En Charge Des Atteintes Proprioceptives Chez Une Population Avec Capsulite Rétractile
- ClinicalTrials.gov ID
- NCT06795932
- Acronym / sponsor ID
- CER-UQAC : 2025-1773
- Keywords
- Adhesive Capsulitis, Frozen shoulder, Tendon Vibration, Transcranial Magnetique Stimulation, Proprioception, Kinesthetic illusions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université du Québec à ChicoutimiUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tendon vibration and standardized exercise protocol | Experimental | Device: Tendon Vibration, Other: ExercicesSix interventions inducing kinesthetic illusions (20 minutes, 1 illusion/minute). Two interventions per week, for three weeks. Accompanied by a daily exercise protocol. |
| Tendon vibration without kinesthetic illusion and standardized exercise protocol | Sham comparator | Other: Exercices, Device: Tendon vibrationSix interventions not inducing kinesthetic illusions (20 minutes) Two interventions per week, for three weeks. Accompanied by a daily exercise protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old and over
- Good general health
- Adhesive capsulitis (experimental group) or
- No shoulder pain (placebo group)
Key exclusion criteria (7 listed)
- Cognitive disorders;
- Any neurological disease/injury affecting the upper limbs;
- History or diagnosis of muscle, tendon, or capsular tear;
- Shoulder surgery/prosthesis;
- Pregnant woman;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendon VibrationVibration 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 | Device | Tendon vibration and standardized exercise protocol |
| ExercicesStandardized exercise protocol, performed daily for 3 weeks, with a diary. | Other | Tendon vibration and standardized exercise protocol, Tendon vibration without kinesthetic illusion and standardized exercise protocol |
| Tendon vibrationTendon 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 | Device | Tendon vibration without kinesthetic illusion and standardized exercise protocol |
Primary outcome
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).
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.
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).
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.
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)
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.
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.
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.
4 secondary outcomes
Sociodemographic - age
Time frame: at baseline 1 : 1 day
Sociodemographic - Sex
Time frame: at baseline 1: 1 day
Sociodemographic - Weight
Time frame: at baseline 1: 1 day
Sociodemographic - Height
Time frame: at baseline 1: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendon Vibration and Exercices in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by Université du Québec à Chicoutimi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Émilie Bouchard, M.Sc. PhD candidate (581-882-0300, e4bouch@uqac.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain And Disability Index (time frame: at baseline 1 and follow-up 1 : 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.