Cubital Tunnel SyndromeNCT00184158
Treatment for Cubital Tunnel Syndrome
A study testing decompression in people with Cubital Tunnel Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments. The study is performed at 5 different hospitals in Norway. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- decompression
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Jan 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with cubital tunnel syndrome
Who cannot join
- Rheumatoid arthritis (RA)
- Osteoarthrosis
- Varus or valgus deformities at elbow
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives
The researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments.
The study is performed at 5 different hospitals in Norway.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- decompression
- Keywords
- Cubital tunnel, treatment, nerve compression
- Medical subject headings
- Cubital Tunnel Syndrome, Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decompressionProcedure or surgery
Conservative, simple decompression and nerve transfer
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Secondary outcomes (4)
electroneurography (ENG
electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
paresthesia
weakness
patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vilhjalmur Finsen, Prof, Study director, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184158
- Sponsor's protocol ID
- 056-02
- Status last verified
- Aug 2017
- First submitted
- 12 Sep 2005
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives
- ClinicalTrials.gov ID
- NCT00184158
- Acronym / sponsor ID
- 056-02
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- Cubital tunnel, treatment, nerve compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Sep 2005 (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 researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments.
The study is performed at 5 different hospitals in Norway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cubital tunnel syndrome
Key exclusion criteria (3 listed)
- Rheumatoid arthritis (RA)
- Osteoarthrosis
- Varus or valgus deformities at elbow
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 |
|---|---|---|
| decompressionConservative, simple decompression and nerve transfer | Procedure or surgery | – |
Primary outcome
pain
4 secondary outcomes
electroneurography (ENG
paresthesia
weakness
patient satisfaction
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 22 Aug 2017.
Related trials for Cubital Tunnel Syndrome
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome
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Recruiting
Comparison of Kinesio Taping Techniques in Ulnar Nerve Entrapment
Ulnar Nerve Entrapment, Cubital Tunnel Syndrome
Not yet recruitingObservational study
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
Recruiting
Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
Cubital Tunnel Syndrome, Electrical Stimulation
Recruiting
Investigation of the Effectiveness of Kinesiological Taping in Cubital Tunnel Syndrome
Cubital Tunnel Syndrome, Kinesio Taping
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.
Vilhjalmur Finsen, Prof study director
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decompression in people with Cubital Tunnel Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
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 22 Aug 2017. 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 Norway. 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?
pain. 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 22 Aug 2017.