Carpal Tunnel SyndromeNCT01201109
Carpal Tunnel Release in Diabetic Patients
An observational study of Carpal Tunnel Syndrome and Diabetes, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Diabetes, Nerve Entrapment
- How many people
- 66 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Dec 2011
- 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: Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.
Who may be able to join
- diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.
Who cannot join
- previous carpal tunnel release in the hand under study
- clinical signs of nerve entrapment other than CTS
- cervical radiculopathy, inflammatory joint disease
- renal failure
- thyroid disorders
- previous wrist fracture on the affected side
- daily long-term exposure to vibrating tools
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients
The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.
Read the detailed description
The Follow-up investigation includes:
- Clinical examination of sensory and motor function
- Generic and disease specific self-administered questionnaires
- Nerve conduction study
- Vibration threshold testing
- Conditions
- Carpal Tunnel Syndrome, Diabetes, Nerve Entrapment
- Keywords
- Carpal tunnel syndrome, Entrapment neuropathies, Diabetes
- Medical subject headings
- Carpal Tunnel Syndrome, Diabetes Mellitus, Nerve Compression Syndromes
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 |
|---|---|---|
| Diabetics | Diabetic patients operated for carpal tunnel syndrome | |
| Non-diabetics | Non-diabetic patients operated for carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reported outcome questionnaire
Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score
Measured: 5 years after carpal tunnel release
Secondary outcomes (1)
Nerve conduction study and vibrotactile sense
Change in Median nerve function by measuring Distal motor latency and antidromic sensory conduction velocity over the carpal tunnel segment.
Evaluate development of peripheral neuropathy by measure of sural nerve sensory conduction velocity, sural nerve amplitude and peroneal nerve motor conduction velocity.
Vibrotactile sense of the hand measured at 7 difference frequences from 5 - 500 Hz.
Measured: 5 years after carpal tunnels release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars Dahlin, Md, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201109
- Sponsor's protocol ID
- 2010/354
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomsen NOB, Dahlin LB. Vibrotactile sense 5 years after carpal tunnel release in people with diabetes: A prospective study with matched controls. Diabet Med. 2021 Jul;38(7):e14453. doi: 10.1111/dme.14453. Epub 2020 Nov 26.
PubMed 33169372
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients
- ClinicalTrials.gov ID
- NCT01201109
- Acronym / sponsor ID
- 2010/354
- Conditions
- Carpal Tunnel Syndrome, Diabetes, Nerve Entrapment
- Keywords
- Carpal tunnel syndrome, Entrapment neuropathies, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Sep 2010 (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 to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.
Detailed description
The Follow-up investigation includes:
- Clinical examination of sensory and motor function
- Generic and disease specific self-administered questionnaires
- Nerve conduction study
- Vibration threshold testing
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics | – | –Diabetic patients operated for carpal tunnel syndrome |
| Non-diabetics | – | –Non-diabetic patients operated for carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.
Key inclusion criteria (1 listed)
- diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.
Key exclusion criteria (8 listed)
- previous carpal tunnel release in the hand under study
- clinical signs of nerve entrapment other than CTS
- 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
Patient self-reported outcome questionnaire
Time frame: 5 years after carpal tunnel release
Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score
1 secondary outcome
Nerve conduction study and vibrotactile sense
Time frame: 5 years after carpal tunnels release
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Derived from this study: PubMed 33169372Thomsen NOB, Dahlin LB. Vibrotactile sense 5 years after carpal tunnel release in people with diabetes: A prospective study with matched controls. Diabet Med. 2021 Jul;38(7):e14453. doi: 10.1111/dme.14453. Epub 2020 Nov 26.
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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, Md, PhD study chair
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 Diabetes, 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 1 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: status not confirmed, as of the sponsor's last update on 28 Sep 2010. 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?
Results are not available in the source record.
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?
Patient self-reported outcome questionnaire (time frame: 5 years after carpal tunnel release). 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 NCT01201109, which also lists 1 linked publication.
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 28 Sep 2010.