Carpal Tunnel SyndromeCTSNCT00694265
Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment
An observational study of Carpal Tunnel Syndrome, run by University of Bern at 1 site in Switzerland.
Trial summary
In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Decompression and Conservative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2002to Dec 2003
- Phase
- Observational
- 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
Study population: Patients with suspected CTS
Who may be able to join
- wrists with established CTS
Who cannot join
- prior surgery for CTS
- traumatic lesions
- coexistent neurological disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Plastic and Hand Surgery, Bern University Hospital
Bern
About this study
Official title: Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment: Prospective Cohort Study.
In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS.
Read the detailed description
Objective:
In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS.
Methods:
Prospective cohort study in 55 consecutive patients with 78 wrists with established CTS, including 60 wrists with surgical decompression and 18 wrists with conservative treatment. A sonographic examination was scheduled before and at 4 months after initiation of treatment. Changes in CSA between wrists with surgical and wrists with conservative treatment were compared using linear regression models.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Decompression, Conservative treatment
- Keywords
- Carpal Tunnel Syndrome, Median Nerve, Ultrasonography, Prospective cohort study
- 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.
DecompressionProcedure or surgery
Surgical decompression of the median nerve
Conservative treatmentProcedure or surgery
Conservative treatment typically consisted of splinting and corticosteroid injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Surgical treatment Receives: Procedure: Decompression | |
| 2 | Conservative treatment Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the largest cross-sectional area (CSA) of the median nerve
Measured: Before and 4 months after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJan 2002
- Primary completionJun 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Peter Jüni, MD, Study director, Institute of Social and Preventive Medicine, University of Bern, SwitzerlandHans-Rudolf Ziswiler, MD, Principal investigator, Dep. of Rheumatology, Immunology and Allergology, Bern University Hospital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694265
- Sponsor's protocol ID
- CTU_CTS
- Other IDs
- UBern_CTS
- Acronym
- CTS
- Status last verified
- Aug 2008
- First submitted
- 6 Jun 2008
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ziswiler HR, Reichenbach S, Vogelin E, Bachmann LM, Villiger PM, Juni P. Diagnostic value of sonography in patients with suspected carpal tunnel syndrome: a prospective study. Arthritis Rheum. 2005 Jan;52(1):304-11. doi: 10.1002/art.20723.
PubMed 15641050Bachmann LM, Juni P, Reichenbach S, Ziswiler HR, Kessels AG, Vogelin E. Consequences of different diagnostic "gold standards" in test accuracy research: Carpal Tunnel Syndrome as an example. Int J Epidemiol. 2005 Aug;34(4):953-5. doi: 10.1093/ije/dyi105. Epub 2005 May 23.
PubMed 15911545
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment: Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT00694265
- Acronym / sponsor ID
- CTS / CTU_CTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Median Nerve, Ultrasonography, Prospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 10 Jun 2008 (estimated)
- 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.
In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS.
Detailed description
Objective:
In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS.
Methods:
Prospective cohort study in 55 consecutive patients with 78 wrists with established CTS, including 60 wrists with surgical decompression and 18 wrists with conservative treatment. A sonographic examination was scheduled before and at 4 months after initiation of treatment. Changes in CSA between wrists with surgical and wrists with conservative treatment were compared using linear regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: DecompressionSurgical treatment |
| 2 | – | Procedure: Conservative treatmentConservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected CTS
Key inclusion criteria (1 listed)
- wrists with established CTS
Key exclusion criteria (3 listed)
- prior surgery for CTS
- traumatic lesions
- coexistent neurological disease
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 |
|---|---|---|
| DecompressionSurgical decompression of the median nerve | Procedure or surgery | 1 |
| Conservative treatmentConservative treatment typically consisted of splinting and corticosteroid injections | Procedure or surgery | 2 |
Primary outcome
Measure of the largest cross-sectional area (CSA) of the median nerve
Time frame: Before and 4 months after initiation of 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 26 Aug 2008.
- Background: PubMed 15641050Ziswiler HR, Reichenbach S, Vogelin E, Bachmann LM, Villiger PM, Juni P. Diagnostic value of sonography in patients with suspected carpal tunnel syndrome: a prospective study. Arthritis Rheum. 2005 Jan;52(1):304-11. doi: 10.1002/art.20723.
- Background: PubMed 15911545Bachmann LM, Juni P, Reichenbach S, Ziswiler HR, Kessels AG, Vogelin E. Consequences of different diagnostic "gold standards" in test accuracy research: Carpal Tunnel Syndrome as an example. Int J Epidemiol. 2005 Aug;34(4):953-5. doi: 10.1093/ije/dyi105. Epub 2005 May 23.
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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.
Peter Jüni, MD study director
Institute of Social and Preventive Medicine, University of Bern, Switzerland
Hans-Rudolf Ziswiler, MD principal investigator
Dep. of Rheumatology, Immunology and Allergology, Bern University Hospital, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by University of Bern at 1 site in Switzerland.
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 3 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 26 Aug 2008. 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 Switzerland. 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?
Measure of the largest cross-sectional area (CSA) of the median nerve (time frame: Before and 4 months after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694265, which also lists 2 linked publications.
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 26 Aug 2008.