Spasticity
Conditions
Keywords
radiofrequency, Thermal Radiofrequency Neurolysis, muscle spasticity, Musculocutaneous nerve
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.
Interventions
DEVICERadiofrequency
Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity
Sponsors
Fundación Pública Galega de Investigación Biomédica INIBIC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goniometry | Baseline, 2 months, and 6 months after treatment | 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. |
| Modified Ashworth Scale | Baseline, 2 months, and 6 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attaintment Scaling | 2 months, and 6 months after treatment. | 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. |
| Visual Analog Scale | Baseline, 2 months, and 6 months after treatment | 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. |
| Spasticity-related Quality Of Life 6-Dimensions (SQoL-6D) | Baseline, 2 months, and 6 months after treatment. | 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. |
| Physician Global Assessment (PGA) | Baseline, 2 months, and 6 months after treatment. | 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. |
| Patient Global Impression of Change (PGI-C) | Baseline, 2 months, and 6 months after treatment | 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. |
Countries
Spain
Outcome results
None listed