SpasticityNCT07712471
Multicenter Study of Thermal Radiofrequency Applied to the Musculocutaneous Nerve for the Treatment of Spasticity
A study testing Radiofrequency in people with Spasticity, run by Fundación Pública Galega de Investigación Biomédica INIBIC at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006
About this study
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
- Being tested
- Radiofrequency
- Keywords
- radiofrequency, Thermal Radiofrequency Neurolysis, muscle spasticity, Musculocutaneous nerve
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity
| Study group | Role | What they receive |
|---|---|---|
| Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity | Experimental | Not described Receives: Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 months, and 6 months after treatment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 months, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Feb 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Galega de Investigación Biomédica INIBIC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Otero Villaverde, Fundación Pública Galega de Investigación Biomédica INIBIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712471
- Sponsor's protocol ID
- 2024/518
- Status last verified
- May 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Thermal Radiofrequency Applied to the Musculocutaneous Nerve for the Treatment of Spasticity
- ClinicalTrials.gov ID
- NCT07712471
- Acronym / sponsor ID
- 2024/518
- Conditions
- Spasticity
- Keywords
- radiofrequency, Thermal Radiofrequency Neurolysis, muscle spasticity, Musculocutaneous nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fundación Pública Galega de Investigación Biomédica INIBICUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity | Experimental | Device: Radiofrequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyThermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity | Device | Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity |
Primary outcome
Goniometry
Time frame: 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
Time frame: 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.
5 secondary outcomes
Goal Attaintment Scaling
Time frame: 2 months, and 6 months after treatment.
Visual Analog Scale
Time frame: Baseline, 2 months, and 6 months after treatment
Spasticity-related Quality Of Life 6-Dimensions (SQoL-6D)
Time frame: Baseline, 2 months, and 6 months after treatment.
Physician Global Assessment (PGA)
Time frame: Baseline, 2 months, and 6 months after treatment.
Patient Global Impression of Change (PGI-C)
Time frame: Baseline, 2 months, and 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Spasticity, run by Fundación Pública Galega de Investigación Biomédica INIBIC at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometry (time frame: Baseline, 2 months, and 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.