Cubital Tunnel SyndromeNCT01893164
Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome
A study testing simple decompression, anterior subcutaneous transposition and anterior intramuscular transposition in people with Cubital Tunnel Syndrome, run by Jilin University at 1 site in China.
Trial summary
The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- simple decompression, anterior subcutaneous transposition and anterior intramuscular transposition
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Oct 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with confirmed cubital tunnel syndrome
- moderate and severe 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
- mild cubital tunnel syndrome.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hand Surgery Department of China-Japan Union Hospital
Changchun, Jilin, 130000
Rui Li, chief doctor, 13304321102, 447567095@qq.com
About this study
Official title: Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome ：A Randomized Double-blind Control Trial
The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.
Read the detailed description
The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- simple decompression, anterior subcutaneous transposition, anterior intramuscular transposition
- Keywords
- cubital tunnel syndrome, simple decompression, anterior subcutaneous transposition of ulnar nerve, anterior intramuscular transposition of ulnar nerve, severity scale
- 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.
simple decompressionProcedure or surgery
Also called SDP
decompression of the ulnar nerve
anterior subcutaneous transpositionProcedure or surgery
Also called ASCT
transposition of the ulnar nerve into subcutaneous bed
anterior intramuscular transpositionProcedure or surgery
Also called AIMT
transposition of the ulnar nerve into muscular tissue
| Study group | Role | What they receive |
|---|---|---|
| moderate cubital tunnel syndrome | Experimental | Sensory,Intermittent paresthesias; vibratory perception normal or decreasedMotor,Measurable weakness in pinch or grip strengthTests,Elbow flexion test or Tinel's sign is positive; finger crossing may be abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve. Receives: Procedure: simple decompression; Procedure: anterior subcutaneous transposition; Procedure: anterior intramuscular transposition |
| severe cubital tunnel syndrome | Experimental | Sensory,Persistent paresthesias; vibratory perception decreased; abnormal two-point discrimination(static >6 mm, moving >4 mm)Motor,Measurable weakness in pinch and grip plus muscle atrophyTests,Positive elbow flexion test or positive Tinel's sign may be present; finger crossing usually abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve. Receives: Procedure: simple decompression; Procedure: anterior subcutaneous transposition; Procedure: anterior intramuscular transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (3)
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
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
electromyography
Compare the result at 6 months post-operatively with the result before operation.To see if there is an improvement in the function of the ulnar nerve.0,no improvement;1,improvement.
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 posted8 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionOct 2014 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Li, Jilin University
- Investigators
- Rui Li, chief doctor, Study chair, Hand Sugery Department of the China-Japan Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893164
- Sponsor's protocol ID
- JilinU-218-RLi
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome ：A Randomized Double-blind Control Trial
- ClinicalTrials.gov ID
- NCT01893164
- Acronym / sponsor ID
- JilinU-218-RLi
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- cubital tunnel syndrome, simple decompression, anterior subcutaneous transposition of ulnar nerve, anterior intramuscular transposition of ulnar nerve, severity scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 8 Jul 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.
The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.
Detailed description
The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate cubital tunnel syndrome | Experimental | Procedure: simple decompression, Procedure: anterior subcutaneous transposition, Procedure: anterior intramuscular transpositionSensory,Intermittent paresthesias; vibratory perception normal or decreasedMotor,Measurable weakness in pinch or grip strengthTests,Elbow flexion test or Tinel's sign is positive; finger crossing may be abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve. |
| severe cubital tunnel syndrome | Experimental | Procedure: simple decompression, Procedure: anterior subcutaneous transposition, Procedure: anterior intramuscular transpositionSensory,Persistent paresthesias; vibratory perception decreased; abnormal two-point discrimination(static >6 mm, moving >4 mm)Motor,Measurable weakness in pinch and grip plus muscle atrophyTests,Positive elbow flexion test or positive Tinel's sign may be present; finger crossing usually abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with confirmed cubital tunnel syndrome
- moderate and severe cubital tunnel syndrome.
Key exclusion criteria (4 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
- mild cubital tunnel syndrome.
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 |
|---|---|---|
| simple decompressionAlso: SDPdecompression of the ulnar nerve | Procedure or surgery | moderate cubital tunnel syndrome, severe cubital tunnel syndrome |
| anterior subcutaneous transpositionAlso: ASCTtransposition of the ulnar nerve into subcutaneous bed | Procedure or surgery | moderate cubital tunnel syndrome, severe cubital tunnel syndrome |
| anterior intramuscular transpositionAlso: AIMTtransposition of the ulnar nerve into muscular tissue | Procedure or surgery | moderate cubital tunnel syndrome, severe cubital tunnel syndrome |
Primary outcome
sensation
Time frame: at 6 months post-operatively
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.
3 secondary outcomes
Muscle strength
Time frame: at 6 months post-operatively
pain
Time frame: at 6 months post-operatively
electromyography
Time frame: at 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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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.
Rui Li, chief doctor study chair
Hand Sugery Department of the China-Japan Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simple decompression, anterior subcutaneous transposition and anterior intramuscular transposition in people with Cubital Tunnel Syndrome, run by Jilin University 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 2 inclusion and 4 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 8 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensation (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 8 Jul 2013.