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Segmental Muscle Vibration on Pain in Patients With Primary Cervical Dystonia

NCT06748846 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Primary Cervical Dystonia

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748846 on ClinicalTrials.gov