Guyon's CanalNCT01994434
Ulnar Nerve Deep Branch Compression by a Ganglion
A study testing Decompression of the ulnar nerve in people with Guyon's Canal and Nerve Compression, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Guyon's Canal, Nerve Compression
- What is being tested?
- Decompression of the ulnar nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Mar 2000to Nov 2012
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ulnar nerve deep branch compression by a ganglion -
Who cannot join
- Ulnar nerve deep branch compression caused by other reasons
- -
Trial locations and contacts
1 site in 1 country.
About this study
Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. According modified Bishop's scoring system, the investigators would evaluate postoperative results of this uncommon nerve lesion.
Read the detailed description
Pre- and post-operative physical examination include assessment of tenderness and strength (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are measured using the E-LINK system. According Bishop's scoring system, the investigators redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.
- Conditions
- Guyon's Canal, Nerve Compression
- Being tested
- Decompression of the ulnar nerve
- Keywords
- Deep branch of the ulnar nerve, Distal ulnar nerve compression
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression of the ulnar nerveProcedure or surgery
Surgical decompression of the Guyon's canal and ganglion excision
| Study group | Role | What they receive |
|---|---|---|
| Decompression of the ulnar nerve | Other | Surgical decompression of the Guyon's canal and ganglion excision Receives: Procedure: Decompression of the ulnar nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Grip strength is measured using the E-LINK system.
Measured: 18-24 months
Tip pinch strength
Tip pinch strength between the thumb and index finger is measured using the E-LINK system.
Measured: 18-24 months
Secondary outcomes (1)
Modified Bishop's scoring system
According Bishop's scoring system, we redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2000
- Primary completionOct 2011
- Study completionNov 2012
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 Guyon's CanalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994434
- Sponsor's protocol ID
- TSWang9804
- Other IDs
- HEBEI-J0821
- Status last verified
- Aug 2012
- First submitted
- 13 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Almeida V, de Carvalho M. Lesion of the deep palmar branch of the ulnar nerve: causes and clinical outcome. Neurophysiol Clin. 2010 Jun;40(3):159-64. doi: 10.1016/j.neucli.2010.01.005. Epub 2010 Feb 17.
PubMed 20513615
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulnar Nerve Deep Branch Compression by a Ganglion
- ClinicalTrials.gov ID
- NCT01994434
- Acronym / sponsor ID
- TSWang9804
- Conditions
- Guyon's Canal, Nerve Compression
- Keywords
- Deep branch of the ulnar nerve, Distal ulnar nerve compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Mar 2000
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Nov 2013 (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.
Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. According modified Bishop's scoring system, the investigators would evaluate postoperative results of this uncommon nerve lesion.
Detailed description
Pre- and post-operative physical examination include assessment of tenderness and strength (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are measured using the E-LINK system. According Bishop's scoring system, the investigators redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decompression of the ulnar nerve | Other | Procedure: Decompression of the ulnar nerveSurgical decompression of the Guyon's canal and ganglion excision |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ulnar nerve deep branch compression by a ganglion -
Key exclusion criteria (2 listed)
- Ulnar nerve deep branch compression caused by other reasons
- -
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 |
|---|---|---|
| Decompression of the ulnar nerveSurgical decompression of the Guyon's canal and ganglion excision | Procedure or surgery | Decompression of the ulnar nerve |
Primary outcome
Grip strength
Time frame: 18-24 months
Grip strength is measured using the E-LINK system.
Tip pinch strength
Time frame: 18-24 months
Tip pinch strength between the thumb and index finger is measured using the E-LINK system.
1 secondary outcome
Modified Bishop's scoring system
Time frame: 18-24 months
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 25 Nov 2013.
- Results publication: PubMed 20513615Almeida V, de Carvalho M. Lesion of the deep palmar branch of the ulnar nerve: causes and clinical outcome. Neurophysiol Clin. 2010 Jun;40(3):159-64. doi: 10.1016/j.neucli.2010.01.005. Epub 2010 Feb 17.
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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?
A study testing Decompression of the ulnar nerve in people with Guyon's Canal and Nerve Compression, run by The Second Hospital of Tangshan at 1 site in China.
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 2 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 25 Nov 2013. 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 China. 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?
Grip strength (time frame: 18-24 months). The study lists 2 primary outcomes in all. 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 NCT01994434, 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 25 Nov 2013.