Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité du Québec à Chicoutimi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years old and over
Good general health
Adhesive capsulitis (experimental group) or
No shoulder pain (placebo group)
Disqualifiers
Cognitive disorders;
Any neurological disease/injury affecting the upper limbs;
History or diagnosis of muscle, tendon, or capsular tear;
Shoulder surgery/prosthesis;
Trial design
Design model
Parallel
Treatments tested in this trial
Tendon Vibration
DeviceVibration 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 interventionStandardized exercise protocol, performed daily for 3 weeks, with a diary.
Tendon vibration
DeviceTendon 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
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Tendon vibration and standardized exercise protocolExperimental treatment 2 interventions
Group B: Tendon vibration without kinesthetic illusion and standardized exercise protocolSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
at baseline 1 and follow-up 1 : 2 months2
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.
Time frame
at baseline 1 and follow-up 1: 2 months3
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).
Time frame
at baseline 1 and follow-up 1: 2 months4
Range of motion
Measuring the active and passive range of motion with a goniometer.
Time frame
at baseline 1 and follow-up 1: 2 monthsSecondary outcomes
1
Sociodemographic - age
Age of each participant, in months
Time frame
at baseline 1 : 1 day2
Sociodemographic - Sex
Physiological sex
Time frame
at baseline 1: 1 day3
Sociodemographic - Weight
kilograms
Time frame
at baseline 1: 1 day4
Sociodemographic - Height
in meters
Time frame
at baseline 1: 1 daySponsors and contacts
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Source ClinicalTrials.gov