Carpal Tunnel SyndromeNCT04302909
Effectiveness of fESWT in the Treatment of CTS
A study testing focused extracorporeal shock wave therapy and night splint in people with Carpal Tunnel Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- focused extracorporeal shock wave therapy and night splint
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 24 Apr 2019to Jun 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate CTS verified by nerve conduction velocity
Who cannot join
- metabolic diseases
- blood clotting problems
- systemic diseases
- polyneuropathy
- chemotherapy during the study
- corticosteroid therapy
Show all 14Show fewer
- use of anticoagulation
- history of trauma/surgery or nerve lesion of the teated extremity
- CTS surgery on the affected hand
- ICD/ pacemaker implantation
- other therapy for the affected hand during the study
- acute inflammation or infections
- severe mental illnesses/psychiatric diseases
- severe neurological diseases
Trial locations and contacts
1 site in 1 country.
Christina Gesslbauer contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
Vienna
Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA, richard.crevenna@meduniwien.ac.at
About this study
Official title: The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study
The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.
Read the detailed description
The aim of this study is to determine the effectiveness of fESWT in patients with carpal tunnel syndrome compared to participants receiving only night splint. Therefore 40 patients with mild to moderate CTS (verified by nerve conduction velocity) will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Evaluation will be performed at baseline (VAS, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (VAS, hand grip, questionnaires), 12 and 24 weeks (VAS, hand grip, electrodiagnostic parameters, questionnaires) after treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- focused extracorporeal shock wave therapy, sham focused extracorporeal shock wave therapy, night splint
- Keywords
- focused extracorporeal 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.
focused extracorporeal shock wave therapyOther
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
sham focused extracorporeal shock wave therapyOther
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
night splintOther
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | fESWT Receives: Other: focused extracorporeal shock wave therapy; Other: night splint |
| Sham Comparator | Sham comparator | Sham fESWT Receives: Other: sham focused extracorporeal shock wave therapy; Other: night splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.
Measured: baseline, 3th,12th and 24th weeks after treatment
Secondary outcomes (5)
hand grip strength
hand grip strength:
Measured: baseline, 3th,12th and 24th weeks after treatment
distal motor latency of the median nerve
electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve.
Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment.
Measured: baseline,12th and 24th weeks after treatment
sensory conduction velocity of the median nerve
electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve.
Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment.
Measured: baseline, 12th and 24th weeks after treatment
SF-36
36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment.
Measured: baseline, 3th,12th and 24th weeks after treatment
Boston Scale
Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment.
Measured: baseline, 3th,12th and 24th weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start24 Apr 2019
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Crevenna, Medical University of Vienna
- Investigators
- Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA, Principal investigator, Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302909
- Sponsor's protocol ID
- 1080/2019
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT04302909
- Acronym / sponsor ID
- 1080/2019
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- focused extracorporeal shock wave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Mar 2020 (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 carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.
Detailed description
The aim of this study is to determine the effectiveness of fESWT in patients with carpal tunnel syndrome compared to participants receiving only night splint. Therefore 40 patients with mild to moderate CTS (verified by nerve conduction velocity) will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Evaluation will be performed at baseline (VAS, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (VAS, hand grip, questionnaires), 12 and 24 weeks (VAS, hand grip, electrodiagnostic parameters, questionnaires) after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: focused extracorporeal shock wave therapy, Other: night splintfESWT |
| Sham Comparator | Sham comparator | Other: sham focused extracorporeal shock wave therapy, Other: night splintSham fESWT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild to moderate CTS verified by nerve conduction velocity
Key exclusion criteria (14 listed)
- metabolic diseases
- blood clotting problems
- systemic diseases
- polyneuropathy
- chemotherapy during the study
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 |
|---|---|---|
| focused extracorporeal shock wave therapy40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints. | Other | Active Comparator |
| sham focused extracorporeal shock wave therapy40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints. | Other | Sham Comparator |
| night splint40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints. | Other | Active Comparator, Sham Comparator |
Primary outcome
VAS
Time frame: baseline, 3th,12th and 24th weeks after treatment
Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.
5 secondary outcomes
hand grip strength
Time frame: baseline, 3th,12th and 24th weeks after treatment
distal motor latency of the median nerve
Time frame: baseline,12th and 24th weeks after treatment
sensory conduction velocity of the median nerve
Time frame: baseline, 12th and 24th weeks after treatment
SF-36
Time frame: baseline, 3th,12th and 24th weeks after treatment
Boston Scale
Time frame: baseline, 3th,12th and 24th weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Christina Gesslbauer contact
Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA principal investigator
Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused extracorporeal shock wave therapy and night splint in people with Carpal Tunnel Syndrome, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Gesslbauer, Dr. (0043 40040043330, christina.gesslbauer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: baseline, 3th,12th and 24th weeks after treatment). 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 10 Mar 2020.