An interventional study of Radiofrequency in Spasticity, sponsored by Fundación Pública Galega de Investigación Biomédica INIBIC. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Fundación Pública Galega de Investigación Biomédica INIBIC · Not applicable, Interventional, and Treatment
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 64 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Fundación Pública Galega de Investigación Biomédica INIBIC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: Radiofrequency
Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity
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.
Time frame: 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.
Time frame: Baseline, 2 months, and 6 months after treatment
Goal Attaintment Scaling
Achievement of individually predefined treatment goals is assessed using Goal Attainment Scaling, a 5-point ordinal scale ranging from -2 to +2: -2 indicates a much worse outcome than expected, -1 a somewhat worse outcome than expected, 0 the expected outcome, +1 a somewhat better outcome than expected, and +2 a much better outcome than expected. Higher scores indicate greater goal attainment and a better outcome.
Time frame: 2 months, and 6 months after treatment.
Visual Analog Scale
Pain intensity is assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity and a worse outcome.
Time frame: Baseline, 2 months, and 6 months after treatment
Spasticity-related Quality Of Life 6-Dimensions (SQoL-6D)
Each of the six dimensions of the Spasticity-Related Quality of Life 6-Dimensions instrument (SQoL-6D) is assessed individually over the previous 7 days using a 5-point ordinal scale ranging from 0 to 4. Higher scores indicate greater impairment and a worse outcome.
Time frame: Baseline, 2 months, and 6 months after treatment.
Physician Global Assessment (PGA)
Overall response to treatment is assessed by the physician using a 9-point ordinal scale ranging from -4 to +4: -4 indicates markedly worse, -3 much worse, -2 worse, -1 slightly worse, 0 no change, +1 slightly improved, +2 improved, +3 much improved, and +4 markedly improved. Higher scores indicate greater improvement and a better outcome.
Time frame: Baseline, 2 months, and 6 months after treatment.
Patient Global Impression of Change (PGI-C)
The patient's overall perception of change following treatment is assessed using the Patient Global Impression of Change (PGI-C), a 7-point ordinal scale ranging from -3 to +3: -3 indicates very much worse, -2 much worse, -1 minimally worse, 0 no change, +1 minimally improved, +2 much improved, and +3 very much improved. Higher scores indicate greater improvement and a better outcome.
Time frame: Baseline, 2 months, and 6 months after treatment
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality considerations.
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Fundación Pública Galega de Investigación Biomédica INIBIC