Segmental Muscle Vibration on Pain in Patients With Primary Cervical Dystonia

NCT06748846 | Active Not Recruiting

• 1 other identifier: VIBRA-DYSTONIA
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Cervical Dystonia; rehabilitation; Focal vibration

Outcome Measures

Primary Outcomes (2)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  Assesses clinical severity, disability, and pain.

  From enrollment to the end of treatment at 5 weeks

• McGill Pain Questionnaire

  Evaluates pain perception and subjective experience.

  From enrollment to the end of treatment at 5 weeks

Secondary Outcomes (1)

• Tsui Score Measures

  From enrollment to the end of treatment at 5 weeks

Study Arms (2)

Focal Muscle Vibration

EXPERIMENTAL

Patients receive 10 sessions of integrated rehabilitation, including 45 minutes of physiotherapy, 15 minutes of therapeutic Focal Muscle Vibration, and 30 minutes of occupational therapy

Device: Physiotherapy + Occupational therapy + Focal Muscle Vibration

Sham Focal Muscle Vibration

SHAM COMPARATOR

Patients receive an identical protocol, but the Focal Muscle Vibration is sham (the vibration device produces sound but no actual vibration).

Device: Physiotherapy + Occupational therapy + Sham Focal Muscle Vibration

Interventions

Physiotherapy + Occupational therapy + Focal Muscle Vibration DEVICE

\- 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.

Focal Muscle Vibration

Physiotherapy + Occupational therapy + Sham Focal Muscle Vibration DEVICE

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.

Sham Focal Muscle Vibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of primary cervical dystonia.
• Pain intensity \>3 on the Numerical Rating Scale (NRS).
• Recent botulinum toxin therapy (within 30 days).
• Age ≥18 years.
• MMSE \>24 (no significant cognitive impairment).

You may not qualify if:

• Non-ambulatory status.
• Generalized dystonia or non-cervical forms.
• Inflammatory, neurodegenerative, or rheumatological disorders.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Centro Fondazione Don Gnocchi "E. Spalenza"

Rovato, Brescia, 25038, Italy

Location

Related Publications (2)

• Tijssen MA, Marsden JF, Brown P. Frequency analysis of EMG activity in patients with idiopathic torticollis. Brain. 2000 Apr;123 ( Pt 4):677-86. doi: 10.1093/brain/123.4.677.

  PMID: 10733999 RESULT

• Buraschi R, Pedersini P, Redegalli G, Pullara R, Pollet J, Rossi M, Gobbo M, Gueli S, Falso M. Efficacy of Segmental Muscle Vibration on Pain Modulation in Patients with Primary Cervical Dystonia Treated with Botulinum Type-A Toxin: A Protocol for a Randomized Controlled Trial. NeuroSci. 2025 Apr 2;6(2):30. doi: 10.3390/neurosci6020030.

  PMID: 40265360 DERIVED

MeSH Terms

Conditions

Cervical Dystonia, Primary

Interventions

Physical Therapy Modalities; Occupational Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: July 18, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

IT (1)