Carpal Tunnel Syndrome (CTS)NCT06912893
Clinical Efficiency Testing of Extracorporeal Radial and Focused Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome
A study testing radial shock wave therapy and focused shock wave therapy in people with Carpal Tunnel Syndrome (CTS), run by University Hospital St. Polten.
Trial summary
The aim of the project is to test the efficacy of extracorporeal shock wave therapy (radial + focused) on clinical outcomes in patients with carpal tunnel syndrome (CTS). Shock wave therapy has already been shown to be potentially effective in the literature. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- radial shock wave therapy and focused shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of all genders
- aged above 18 years
- suffering from mild to moderate carpal tunnel syndrome with typical symptoms like pain, paresthesia, or fine motoric disorders:
- very mild (grade 1): sensory nerve conduction velocity mildly reduced orslowercompared to the contralateral side.
- mild (grade 2): distal motor latency <4,5ms and sensory nerve conduction velocity < 40 m/s
- moderate (grade 3): distal motor latency between 4,5 and 6,5 ms and preserved sensory nerve amplitude.
- Patients with bilateral CTS also will be included, whereas the less symptomatic hand will be assessed as well, but receive no therapy.
Who cannot join
- Patients with severe CTS (distal motor latency above 6,5ms or absent sensory potentials);
- Prior therapy (even night splints) for CTS within the last six months
- The presence of common systemic diseases, that have known influence on the peripheral nerve system, like diabetes mellitus, polyneuropathy orabusive C2 consumption
- Postsurgical CTS
- Patients with serious injury of the wrist in medical history (e.g. radius fracture) or previous damage to median nerve and more proximal located compression syndrome of median nerve
- Patients with implanted electronic devices like defibrillators or pacemakers
- Pregnant women
- bifid median nerve;
About this study
Official title: Efficacy of Radial and Focused Extracorporeal Shockwave Therapy in Patients Wirh Carpal Tunnel Syndrom. a Multicentric, Randomised Observer-blinded Trial
The aim of the project is to test the efficacy of extracorporeal shock wave therapy (radial + focused) on clinical outcomes in patients with carpal tunnel syndrome (CTS). Shock wave therapy has already been shown to be potentially effective in the literature. However, no studies are known to date that test both shock wave types in one protocol, and the follow-up period in the previous studies was set at a maximum of 24 weeks.
Consequently, this study is planned as a multicenter, prospective, randomized, investigator-blinded study. 60 subjects will be assigned to the two shock wave types, and the follow-up period is scheduled for 32 weeks.
Read more
The study will be conducted at the Institute for Physical Medicine and Rehabilitation at the University Hospital Krems and St. Pölten. Recruitment will take place through the respective CTS outpatient clinics of the departments, as well as through private practice (orthopedists, general practitioners, neurologists, etc.). The inclusion and exclusion criteria are checked before the subject is included in the study, with nerve conduction velocity (NCV) being emphasized as a diagnostic method.
After the patient is included in the study or signs the consent form, the relevant demographic, medical, and personal data are collected (pseudonymized procedure). Study-related measurements are then performed (nerve sonography, Boston Carpal Tunnel Questionnaire, Visual Analog Scale). The baseline examinations and follow-up examinations are each performed by the same physician (blinded), while the subsequent shock wave therapy is performed by a second physician.
After the baseline examinations, the patient is randomly assigned to one of the two shock wave groups and receives five shock wave therapy sessions one week apart. The pulses and frequency of both treatments are identical (2000 and 5 Hz, respectively). The intensity is xx bar in the radial group and 0.05 mj/mm² in the focused group.
Detailed follow-up assessments, including all baseline measurements, will be conducted 16 and 32 weeks after the first shock wave therapy. At weeks 8 and 24, a questionnaire (Boston Carpal Tunnel Questionnaire; VAS) will also be sent to the patient.
Patients with bilateral clinical CTS will serve as the control group. In this case, the more symptomatic hand will be assigned to a shock wave treatment group, while the other hand will serve as a control. This means no treatment, but all measurements will be performed in the same way as in the study groups.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- radial shock wave therapy, focused shock wave therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial shock wave therapyDevice
treatment of the nervus medianus on the level of the carpal tunnel with radial shock wave therapy with 1500 impulses, 5 Hz and 1,5 bar
focused shock wave therapyDevice
treatment of the nervus medianus on the level of the carpal tunnel with focused shock wave therapy with 1500 impulses, 5 Hz and 0,05 mJ/mm²
| Study group | Role | What they receive |
|---|---|---|
| focused shockwave therapy | Active comparator | this arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with focused shockwave therapy Receives: Device: focused shock wave therapy |
| radial shockwave therapy | Active comparator | this arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with radial shockwave therapy Receives: Device: radial shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
The patient will be asked to categorize his pain and paresthesia on a numeric scale between 0 and 10.
Measured: from enrollment until 32 weeks after first shockwave session
Boston Carpal Tunnel Questionnaire
Questionnaire to evaluate symptoms and functional restriction in daily activities in patients with CTS
Measured: from enrollment until 32 weeks after first shockwave session
Secondary outcomes (3)
Nerve conduction study parameters
Distal motor latency (DML):The electrode for assessingt he motoric fibers of the median nerve will be applied on the muscle belly of the thenar muscles. The orthodromic motoric stimulation will be performed 6,5 centimeters proxima l to the recording site at the height of the wrist with a single electric impulse. The time between stimulation and the initialincrease of the respondingcompoundm usclea ction potential (CMAP)i s namedt he DML.
Measured: from enrollment until 32 weeks after first shockwave session
Neurosonography of median nerve
- Cross-sectional area (CSA): The cross-sectional area of the median nerve will be measured at a typical location at the height of the os pisiforme. The increase in CSA is a well-investigated finding in CTS patients with a cut-off value of about 10 mm2.
- CSA differences: At the proximal third of the pronatorquadratus muscle (>10 centimeteß proximal) a second CSA measurement of the median nerve will be carried out. The difference between the proximal and the dista l values is also a specific and sensitive diagnostic criterion for CTS
Measured: from enrollment until 32 weeks after first shockwave session
Nerve conduction study parameters
-Sensory nerve conduction velocity: A ring electrode (cathode) is placed on the index finger at the height of the proximal interphalangeal joint. The median nerve will be electrically stimulated antidromically at the same height on the wrist as in DML measurement (approximately 13-14 centimeters proximal to the recording site). For calculation of the nerve conduction velocity, the knowledge of the exact distance between the stimulation and the recording site of the nerve is necessary and therefore will be measure
Measured: from enrollment until 32 weeks after first shockwave session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital St. Polten
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Constantin Dolle, University Hospital St. Polten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912893
- Sponsor's protocol ID
- GS3-EK-1/222-2024
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radial and Focused Extracorporeal Shockwave Therapy in Patients Wirh Carpal Tunnel Syndrom. a Multicentric, Randomised Observer-blinded Trial
- ClinicalTrials.gov ID
- NCT06912893
- Acronym / sponsor ID
- GS3-EK-1/222-2024
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital St. PoltenUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 6 Apr 2025 (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.
The aim of the project is to test the efficacy of extracorporeal shock wave therapy (radial + focused) on clinical outcomes in patients with carpal tunnel syndrome (CTS). Shock wave therapy has already been shown to be potentially effective in the literature. However, no studies are known to date that test both shock wave types in one protocol, and the follow-up period in the previous studies was set at a maximum of 24 weeks.
Consequently, this study is planned as a multicenter, prospective, randomized, investigator-blinded study. 60 subjects will be assigned to the two shock wave types, and the follow-up period is scheduled for 32 weeks.
The study will be conducted at the Institute for Physical Medicine and Rehabilitation at the University Hospital Krems and St. Pölten. Recruitment will take place through the respective CTS outpatient clinics of the departments, as well as through private practice (orthopedists, general practitioners, neurologists, etc.). The inclusion and exclusion criteria are checked before the subject is included in the study, with nerve conduction velocity (NCV) being emphasized as a diagnostic method.
After the patient is included in the study or signs the consent form, the relevant demographic, medical, and personal data are collected (pseudonymized procedure). Study-related measurements are then performed (nerve sonography, Boston Carpal Tunnel Questionnaire, Visual Analog Scale). The baseline examinations and follow-up examinations are each performed by the same physician (blinded), while the subsequent shock wave therapy is performed by a second physician.
After the baseline examinations, the patient is randomly assigned to one of the two shock wave groups and receives five shock wave therapy sessions one week apart. The pulses and frequency of both treatments are identical (2000 and 5 Hz, respectively). The intensity is xx bar in the radial group and 0.05 mj/mm² in the focused group.
Detailed follow-up assessments, including all baseline measurements, will be conducted 16 and 32 weeks after the first shock wave therapy. At weeks 8 and 24, a questionnaire (Boston Carpal Tunnel Questionnaire; VAS) will also be sent to the patient.
Patients with bilateral clinical CTS will serve as the control group. In this case, the more symptomatic hand will be assigned to a shock wave treatment group, while the other hand will serve as a control. This means no treatment, but all measurements will be performed in the same way as in the study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| focused shockwave therapy | Active comparator | Device: focused shock wave therapythis arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with focused shockwave therapy |
| radial shockwave therapy | Active comparator | Device: radial shock wave therapythis arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with radial shockwave therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of all genders
- aged above 18 years
- suffering from mild to moderate carpal tunnel syndrome with typical symptoms like pain, paresthesia, or fine motoric disorders:
- Patients with bilateral CTS also will be included, whereas the less symptomatic hand will be assessed as well, but receive no therapy.
Key exclusion criteria (8 listed)
- Patients with severe CTS (distal motor latency above 6,5ms or absent sensory potentials);
- Prior therapy (even night splints) for CTS within the last six months
- The presence of common systemic diseases, that have known influence on the peripheral nerve system, like diabetes mellitus, polyneuropathy orabusive C2 consumption
- Postsurgical CTS
- Patients with serious injury of the wrist in medical history (e.g. radius fracture) or previous damage to median nerve and more proximal located compression syndrome of median nerve
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 |
|---|---|---|
| radial shock wave therapytreatment of the nervus medianus on the level of the carpal tunnel with radial shock wave therapy with 1500 impulses, 5 Hz and 1,5 bar | Device | radial shockwave therapy |
| focused shock wave therapytreatment of the nervus medianus on the level of the carpal tunnel with focused shock wave therapy with 1500 impulses, 5 Hz and 0,05 mJ/mm² | Device | focused shockwave therapy |
Primary outcome
Numeric Rating Scale
Time frame: from enrollment until 32 weeks after first shockwave session
The patient will be asked to categorize his pain and paresthesia on a numeric scale between 0 and 10.
Boston Carpal Tunnel Questionnaire
Time frame: from enrollment until 32 weeks after first shockwave session
Questionnaire to evaluate symptoms and functional restriction in daily activities in patients with CTS
3 secondary outcomes
Nerve conduction study parameters
Time frame: from enrollment until 32 weeks after first shockwave session
Neurosonography of median nerve
Time frame: from enrollment until 32 weeks after first shockwave session
Nerve conduction study parameters
Time frame: from enrollment until 32 weeks after first shockwave session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome (CTS)
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing radial shock wave therapy and focused shock wave therapy in people with Carpal Tunnel Syndrome (CTS), run by University Hospital St. Polten.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Numeric Rating Scale (time frame: from enrollment until 32 weeks after first shockwave session). 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 6 Apr 2025.