Clinical Research Directory
Browse clinical research sites, groups, and studies.
Segmental Muscle Vibration on Pain in Patients With Primary Cervical Dystonia
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Summary
This pilot study aims to evaluate the effectiveness of Vibration Muscle Stimulation (VMS) in reducing pain and improving quality of life in patients with primary cervical dystonia (CD), a focal dystonia characterized by involuntary and often painful muscle contractions in the neck. The study will involve patients who have been treated with botulinum toxin and are candidates for an integrated rehabilitation program, which includes physiotherapy and occupational therapy. Participants will be randomized into two groups: an experimental group receiving therapeutic VMS (80 Hz frequency, 0.5 mm vibration amplitude) and a control group receiving sham VMS. Both groups will undergo a 10-session rehabilitation program combining 45 minutes of physiotherapy and 15 minutes of VMS (or sham), followed by 30 minutes of occupational therapy. The primary outcome measure will be pain and disability as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and the McGill Pain Questionnaire. Secondary outcomes will include improvements in quality of life and clinical severity of dystonia. The results are expected to provide insights into the potential role of VMS in enhancing rehabilitation outcomes for patients with cervical dystonia.
Official title: Efficacy of Segmental Muscle Vibration on Pain Modulation in Patients With Primary Cervical Dystonia: a Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2022-07-18
Completion Date
2027-07-01
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
Physiotherapy + Occupational therapy + Focal Muscle Vibration
\- Physiotherapy (60 minutes): Includes active strengthening of antagonist muscles, mobilization, stretching of cervical-thoracic kinetic chains, proprioceptive control, postural exercises, and body schema modulation. -Occupational Therapy (30 minutes): Focuses on improving proprioceptive, praxis, and spatial control of movements. -SMV (15 minutes): Administered during the last part of each physiotherapy session. Experimental Group: SMV is applied to the trapezius (middle/descending fibers) and quadratus lumborum bilaterally at 80 Hz with an amplitude of 0.5 mm.
Physiotherapy + Occupational therapy + Sham Focal Muscle Vibration
Physiotherapy (60 minutes): Includes active strengthening of antagonist muscles, mobilization, stretching of cervical-thoracic kinetic chains, proprioceptive control, postural exercises, and body schema modulation. Occupational Therapy (30 minutes): Focuses on improving proprioceptive, praxis, and spatial control of movements. SMV (15 minutes): Administered during the last part of each physiotherapy session. Control Group: Sham SMV using disconnected terminals produces sound but no vibration, ensuring blinding.
Locations (1)
Centro Fondazione Don Gnocchi "E. Spalenza"
Rovato, Brescia, Italy