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

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.

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.

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.

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.

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.

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.

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.