Multicenter Study of Thermal Radiofrequency Applied to the Musculocutaneous Nerve for the Treatment of Spasticity

NCT07712471 | Completed

• 1 other identifier: 2024/518
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter observational study evaluates the safety and effectiveness of ultrasound-guided thermal radiofrequency applied to the musculocutaneous nerve in adult patients with focal elbow flexor spasticity secondary to central nervous system injury. Hypothesis: Thermal radiofrequency treatment of the musculocutaneous nerve in patients with spasticity resulting from damage to the central nervous system is a safe and effective treatment for spasticity.

Conditions

Spasticity

Keywords

radiofrequency; Thermal Radiofrequency Neurolysis; muscle spasticity; Musculocutaneous nerve

Outcome Measures

Primary Outcomes (2)

• Goniometry

  Passive elbow range of motion assessed by goniometry. Maximum passive elbow extension is measured in degrees using a standard goniometer. Values range from -160°, indicating complete elbow flexion, to 0°, indicating complete elbow extension. Higher values (closer to 0°) indicate greater passive elbow extension and a better outcome, whereas more negative values indicate a worse outcome.

  Baseline, 2 months, and 6 months after treatment

• Modified Ashworth Scale

  Elbow flexor muscle tone is assessed using the Modified Ashworth Scale, a 6-category ordinal scale with scores of 0, 1, 1+, 2, 3, and 4. The minimum score is 0, indicating no increase in muscle tone, and the maximum score is 4, indicating that the affected limb is rigid in flexion or extension. Higher scores indicate greater muscle tone and a worse outcome.

  Baseline, 2 months, and 6 months after treatment

Secondary Outcomes (5)

• Goal Attaintment Scaling

  2 months, and 6 months after treatment.

• Visual Analog Scale

  Baseline, 2 months, and 6 months after treatment

• Spasticity-related Quality Of Life 6-Dimensions (SQoL-6D)

  Baseline, 2 months, and 6 months after treatment.

• Physician Global Assessment (PGA)

  Baseline, 2 months, and 6 months after treatment.

• Patient Global Impression of Change (PGI-C)

  Baseline, 2 months, and 6 months after treatment

Study Arms (1)

Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity

EXPERIMENTAL

Device: Radiofrequency

Interventions

Radiofrequency DEVICE

Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity

Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity

Eligibility Criteria

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

You may qualify if:

• Signed informed consent.
• Age 18 years or older.
• Diagnosis of spasticity secondary to central nervous system injury.
• Predominant elbow flexor spastic pattern dependent on the musculocutaneous nerve.
• Patients with severe spasticity refractory to conservative treatments who underwent thermal radiofrequency treatment of the musculocutaneous nerve during the study period.

You may not qualify if:

• No signed informed consent.
• Age under 18 years.
• Radiofrequency treatment applied to patients without central nervous system injury.
• Absence of follow-up after radiofrequency treatment, for any reason, for a minimum period of 2 months.

Sponsors & Collaborators

• Fundación Pública Galega de Investigación Biomédica INIBIC: lead

Study Sites (1)

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor in Physical and Rehabilitation Medicine

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: February 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)