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O estudo clínico NCT06795932 para Adhesive Capsulitis of the Shoulder, Ombro congelado está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices 30 Não invasivo Randomizado Design adaptativo Exercício
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06795932 é um estudo intervencionista para Adhesive Capsulitis of the Shoulder, Ombro congelado. Seu status atual é: em recrutamento. O estudo começou em 17 de outubro de 2024 e pretende incluir 30 participantes. Coordenado por Université du Québec à Chicoutimi e deve ser concluído em 1 de abril de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 28 de janeiro de 2025.
Resumo
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 kinesthet...
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Prise En Charge Des Atteintes Proprioceptives Chez Une Population Avec Capsulite Rétractile
Condições médicas
Adhesive Capsulitis of the ShoulderOmbro congeladoOutros IDs do estudo
- CER-UQAC : 2025-1773
Número NCT
Data de início (real)
2024-10-17
Última atualização postada
2025-01-28
Data de conclusão (estimada)
2027-04
Inscrição (estimada)
30
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Adhesive Capsulitis
Frozen shoulder
Tendon Vibration
Transcranial Magnetique Stimulation
Proprioception
Kinesthetic illusions
Frozen shoulder
Tendon Vibration
Transcranial Magnetique Stimulation
Proprioception
Kinesthetic illusions
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Quádruplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalTendon 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. | 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 Exercices Standardized exercise protocol, performed daily for 3 weeks, with a diary. |
Comparador simuladoTendon 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. | Exercices Standardized exercise protocol, performed daily for 3 weeks, with a diary. 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- 18 years old and over
- Good general health
- Adhesive capsulitis (experimental group) or
- No shoulder pain (placebo group)
- 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.
Université du Québec à ChicoutimiContato central do estudo
Contato: Émilie Bouchard, M.Sc. PhD candidate, 581-882-0300, [email protected]
Contato: Louis-David Beaulieu, PhD, 418 545-5011, [email protected]
1 Locais do estudo em 1 países
Quebec
Lab BioNR - UQAC, Saguenay, Quebec, G7H 2B1, Canada
Émilie Bouchard, M.Sc. PhD candidate, Contato, 581-882-0300, [email protected]
Em recrutamento