Cubital Tunnel SyndromePhase 2NCT01109901
Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome
A Phase 2 study testing anterior subcutaneous transposition and Anterior submuscular transposition in people with Cubital Tunnel Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- anterior subcutaneous transposition and Anterior submuscular transposition
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Oct 2008to Mar 2009
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with confirmed cubital tunnel syndrome
Who cannot join
- Significant cervical spine and shoulder disease
- deformity or distortion of the cubital tunnel due to previous trauma to elbow
- recurrent cubital tunnel syndrome after previous surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Surgical Methods for Cubital Tunnel Syndrome
The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.
Read the detailed description
Compression of the ulnar nerve at the cubital tunnel is the most common cause of numbness on the ulnar side of the hand. We aimed to compare patient outcomes included pain, sensation, muscle strength and muscle atrophy in two methods of surgery contain Anterior Sub Cutaneous Transposition (ASCT) and Anterior Sub Muscular Transposition (ASMT) of the ulnar nerve in Cubital tunnel syndrome.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- anterior subcutaneous transposition, Anterior submuscular transposition
- Keywords
- Cubital tunnel,subcutaneous transposition,submuscular
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior subcutaneous transpositionProcedure or surgery
Also called ASCT
transposition of ulnar nerve into subcutaneous bed
Anterior submuscular transpositionProcedure or surgery
Also called ASMT
transposition of ulnar nerve into muscular tissue
| Study group | Role | What they receive |
|---|---|---|
| anterior submuscular transposition | Other | it is kind of surgical method Receives: Procedure: Anterior submuscular transposition |
| Anterior subcutaneous transposition | Other | it is kind of surgical method Receives: Procedure: anterior subcutaneous transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analogue Scale (VAS) with scores of zero to ten (0 for no pain and 10 intolerable pain) then scored as follows: 0, Sever (8-10); 1, Slight (4-7); 2, none (0-3)
Measured: at 6 months post-operatively
Secondary outcomes (3)
sensation
Sensory disturbance were tested with Semmes-Weinstein filaments and sensory deficits were categorized according to the Yale sensory scale. According to standard scoring system that designed, the severity of sensation and function of the ulnar nerve was scored as follows: 0, Abscent sensation; 1, Decrease or abnormal sensation; 2, Intact sensation.
Measured: at 6 months post-operatively
Muscle strength
Muscle strength was evaluated with the grading system from the Medical Research Council which is based upon a scale of zero to five: 0, No muscle contraction; 1,Flicker or trace of muscle contraction; 2,Limb or joint movement possible only with gravity eliminated; 3,Limb or joint movement against gravity only; 4,Power decreased but limb or joint movement possible against resistance; 5,Normal power against resistance. Then results were scored as follows: 0,Poor (0-1); 1,Moderate (2-3); 2,Good (4-5)
Measured: at 6 months post-operatively
Muscle atrophy
Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
Measured: at 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamidreza Shemshaki, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109901
- Sponsor's protocol ID
- ASD-1213
- Status last verified
- Oct 2008
- First submitted
- 19 Apr 2010
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Surgical Methods for Cubital Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT01109901
- Acronym / sponsor ID
- ASD-1213
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- Cubital tunnel,subcutaneous transposition,submuscular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Apr 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 purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.
Detailed description
Compression of the ulnar nerve at the cubital tunnel is the most common cause of numbness on the ulnar side of the hand. We aimed to compare patient outcomes included pain, sensation, muscle strength and muscle atrophy in two methods of surgery contain Anterior Sub Cutaneous Transposition (ASCT) and Anterior Sub Muscular Transposition (ASMT) of the ulnar nerve in Cubital tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior submuscular transposition | Other | Procedure: Anterior submuscular transpositionit is kind of surgical method |
| Anterior subcutaneous transposition | Other | Procedure: anterior subcutaneous transpositionit is kind of surgical method |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with confirmed cubital tunnel syndrome
Key exclusion criteria (3 listed)
- Significant cervical spine and shoulder disease
- deformity or distortion of the cubital tunnel due to previous trauma to elbow
- recurrent cubital tunnel syndrome after previous surgery.
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 |
|---|---|---|
| anterior subcutaneous transpositionAlso: ASCTtransposition of ulnar nerve into subcutaneous bed | Procedure or surgery | Anterior subcutaneous transposition |
| Anterior submuscular transpositionAlso: ASMTtransposition of ulnar nerve into muscular tissue | Procedure or surgery | anterior submuscular transposition |
Primary outcome
Pain
Time frame: at 6 months post-operatively
Visual Analogue Scale (VAS) with scores of zero to ten (0 for no pain and 10 intolerable pain) then scored as follows: 0, Sever (8-10); 1, Slight (4-7); 2, none (0-3)
3 secondary outcomes
sensation
Time frame: at 6 months post-operatively
Muscle strength
Time frame: at 6 months post-operatively
Muscle atrophy
Time frame: at 6 months post-operatively
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 23 Apr 2010.
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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.
hamidreza Shemshaki, MD study chair
MD,research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anterior subcutaneous transposition and Anterior submuscular transposition in people with Cubital Tunnel Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 23 Apr 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: at 6 months post-operatively). 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 23 Apr 2010.