Carpal Tunnel SyndromeNCT00775333
Nerve Entrapment in Diabetic Patients
An observational study of Carpal Tunnel Syndrome and Entrapment Neuropathies, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Entrapment Neuropathies, Nerve Compression Syndromes
- What is being tested?
- Outcome after carpal tunnel release
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2003to Apr 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to a specialized hand clinic
Who may be able to join
- Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome
- Confirmed by nerve conduction studies.
Who cannot join
- Other focal nerve entrapments
- Cervical radiculopathy
- Inflammatory joint disease
- Renal failure
- Thyroid disorders
- Previous wrist fracture
- Long-term exposure to vibrating tools.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls
The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.
- Conditions
- Carpal Tunnel Syndrome, Entrapment Neuropathies, Nerve Compression Syndromes, Diabetes Complications
- Being tested
- Outcome after carpal tunnel release
- Keywords
- Carpal Tunnel Syndrome, Diabetes, APB strength, Sensory Function, Pillar Pain, Cold Intolerance, Patient Satisfaction
- Medical subject headings
- Carpal Tunnel Syndrome, Nerve Compression Syndromes, Diabetes Complications, Diabetes Mellitus, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome after carpal tunnel releaseProcedure or surgery
Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with diabetes and carpal tunnel syndrome | |
| 2 | Non-diabetic patients with carpal tunnel syndrome Receives: Procedure: Outcome after carpal tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength)
Measured: Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcomes (1)
Pillar pain, cold intolerance, and patient satisfaction.
Measured: Baseline, 6 weeks, 12 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startDec 2003
- Study completionApr 2008
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars Dahlin, PHD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775333
- Sponsor's protocol ID
- LU 508-03
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls
- ClinicalTrials.gov ID
- NCT00775333
- Acronym / sponsor ID
- LU 508-03
- Conditions
- Carpal Tunnel Syndrome, Entrapment Neuropathies, Nerve Compression Syndromes, Diabetes Complications
- Keywords
- Carpal Tunnel Syndrome, Diabetes, APB strength, Sensory Function, Pillar Pain, Cold Intolerance, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Oct 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.
The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with diabetes and carpal tunnel syndrome |
| 2 | – | Procedure: Outcome after carpal tunnel releaseNon-diabetic patients with carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to a specialized hand clinic
Key inclusion criteria (2 listed)
- Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome
- Confirmed by nerve conduction studies.
Key exclusion criteria (7 listed)
- Other focal nerve entrapments
- Cervical radiculopathy
- Inflammatory joint disease
- Renal failure
- Thyroid disorders
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 |
|---|---|---|
| Outcome after carpal tunnel releaseFollow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients | Procedure or surgery | 2 |
Primary outcome
Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength)
Time frame: Baseline, 6 weeks, 12 weeks, 52 weeks
1 secondary outcome
Pillar pain, cold intolerance, and patient satisfaction.
Time frame: Baseline, 6 weeks, 12 weeks, 52 weeks
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 Oct 2008.
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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.
Lars Dahlin, PHD principal investigator
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 and Entrapment Neuropathies, run by Skane University Hospital at 1 site in Sweden.
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 2 inclusion and 7 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 Oct 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 Sweden. 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?
Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength) (time frame: Baseline, 6 weeks, 12 weeks, 52 weeks). 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 Oct 2008; AzTrials last refreshed its copy on 26 Oct 2026.