Peripheral NeuropathyNCT00856011
Nerve Morphology in Diabetic Patients
An observational study of Peripheral Neuropathy and Carpal Tunnel Syndrome, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Neuropathy, Carpal Tunnel Syndrome, Entrapment Neuropathies
- How many people
- 46 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 of carpal tunnel syndrome based in clinical history and symptoms
- 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
- Age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posterior Interosseous Nerve Pathology May Provide Novel Insights Into Both Predisposition and Potential Vascular Basis for the Development of Carpal Tunnel Syndrome in Diabetic Patients.
The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS.
- Conditions
- Peripheral Neuropathy, Carpal Tunnel Syndrome, Entrapment Neuropathies, Diabetes Complications
- Medical subject headings
- Peripheral Nervous System Diseases, Carpal Tunnel Syndrome, Nerve Compression Syndromes, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Diabetic patients with carpal tunnel syndrome | |
| 2 | Non-diabetic patients with carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (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 Peripheral NeuropathyStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856011
- Sponsor's protocol ID
- LU 508-03 (2003)
- Status last verified
- Mar 2009
- First submitted
- 4 Mar 2009
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Interosseous Nerve Pathology May Provide Novel Insights Into Both Predisposition and Potential Vascular Basis for the Development of Carpal Tunnel Syndrome in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT00856011
- Acronym / sponsor ID
- LU 508-03 (2003)
- Conditions
- Peripheral Neuropathy, Carpal Tunnel Syndrome, Entrapment Neuropathies, Diabetes Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Mar 2009 (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 underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diabetic patients with carpal tunnel syndrome |
| 2 | – | –Non-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 of carpal tunnel syndrome based in clinical history and symptoms
- Confirmed by nerve conduction studies
Key exclusion criteria (8 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.
Primary outcome
Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space
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 5 Mar 2009.
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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?
An observational study of Peripheral Neuropathy and Carpal Tunnel Syndrome, 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 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: finished, as of the sponsor's last update on 5 Mar 2009. 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?
Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space. 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 5 Mar 2009.