Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01109901
First received: April 19, 2010
Last updated: April 22, 2010
Last verified: October 2008
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Purpose
The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Cubital Tunnel Syndrome |
Procedure: anterior subcutaneous transposition Procedure: Anterior submuscular transposition |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study of Surgical Methods for Cubital Tunnel Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
Further study details as provided by Isfahan University of Medical Sciences:
Primary Outcome Measures:
- Pain [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]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)
Secondary Outcome Measures:
- sensation [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]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.
- Muscle strength [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]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)
- Muscle atrophy [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
| Enrollment: | 48 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
anterior submuscular transposition
it is kind of surgical method
|
Procedure: Anterior submuscular transposition
transposition of ulnar nerve into muscular tissue
Other Name: ASMT
|
|
Anterior subcutaneous transposition
it is kind of surgical method
|
Procedure: anterior subcutaneous transposition
transposition of ulnar nerve into subcutaneous bed
Other Name: ASCT
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- patients with confirmed cubital tunnel syndrome
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109901
Locations
| Iran, Islamic Republic of | |
| Al-zahra university hospital | |
| Isfahan, Iran, Islamic Republic of, 70007 | |
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
| Study Chair: | hamidreza Shemshaki, MD | MD,research comittee |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01109901 History of Changes |
| Other Study ID Numbers: | ASD-1213 |
| Study First Received: | April 19, 2010 |
| Last Updated: | April 22, 2010 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Isfahan University of Medical Sciences:
|
Cubital tunnel,subcutaneous transposition,submuscular |
Additional relevant MeSH terms:
|
Cumulative Trauma Disorders Cubital Tunnel Syndrome Ulnar Neuropathies Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Ulnar Nerve Compression Syndromes Nerve Compression Syndromes Sprains and Strains Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013