Carpal Tunnel SyndromeNCT03062722
Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
A study testing keyhole approach in people with Carpal Tunnel Syndrome and Entrapment Neuropathy, run by Ivan Segura Duran.
Trial summary
Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Entrapment Neuropathy
- What is being tested?
- keyhole approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jul 2016
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.
Who cannot join
- Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.
About this study
Official title: Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory
Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.
Read the detailed description
Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.
- Conditions
- Carpal Tunnel Syndrome, Entrapment Neuropathy
- Being tested
- keyhole approach
- Keywords
- microsurgical treatment, pain, dexterity, Phalen sign, functional status
- Medical subject headings
- Carpal Tunnel Syndrome, Charcot-Marie-Tooth Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keyhole approachProcedure or surgery
The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.
| Study group | Role | What they receive |
|---|---|---|
| keyhole approach | Experimental | open minimally invasive approach Receives: Procedure: keyhole approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levine Severity Scale
pain grades with 5 grades of intensity
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jan 2015
- Primary completion1 Dec 2015
- Study completion1 Jul 2016
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 Carpal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivan Segura Duran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivan Segura Duran, University of Guadalajara
- Investigators
- Rodrigo Ramos Zuñiga, M.D. PhD, Principal investigator, Universidad se Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062722
- Sponsor's protocol ID
- CI.063-2014
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos-Zuniga R, Garcia-Mercado CJ, Segura-Duran I, Zepeda-Gutierrez LA. Efficacy of Keyhole Approach to Carpal Tunnel Syndrome under Ambulatory Strategy. Neurol Res Int. 2017;2017:3549291. doi: 10.1155/2017/3549291. Epub 2017 Apr 6.
PubMed 28484650
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory
- ClinicalTrials.gov ID
- NCT03062722
- Acronym / sponsor ID
- CI.063-2014
- Conditions
- Carpal Tunnel Syndrome, Entrapment Neuropathy
- Keywords
- microsurgical treatment, pain, dexterity, Phalen sign, functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ivan Segura DuranUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.
Detailed description
Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| keyhole approach | Experimental | Procedure: keyhole approachopen minimally invasive approach |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.
Key exclusion criteria (1 listed)
- Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.
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 |
|---|---|---|
| keyhole approachThe surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch. | Procedure or surgery | keyhole approach |
Primary outcome
Levine Severity Scale
Time frame: 2 years follow up
pain grades with 5 grades of intensity
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 Feb 2017.
- Derived from this study: PubMed 28484650Ramos-Zuniga R, Garcia-Mercado CJ, Segura-Duran I, Zepeda-Gutierrez LA. Efficacy of Keyhole Approach to Carpal Tunnel Syndrome under Ambulatory Strategy. Neurol Res Int. 2017;2017:3549291. doi: 10.1155/2017/3549291. Epub 2017 Apr 6.
- Individual participant dataSharing planned: No
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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.
Rodrigo Ramos Zuñiga, M.D. PhD principal investigator
Universidad se Guadalajara
Questions about this trial
What is this clinical trial studying?
A study testing keyhole approach in people with Carpal Tunnel Syndrome and Entrapment Neuropathy, run by Ivan Segura Duran.
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 1 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Levine Severity Scale (time frame: 2 years follow up). 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 NCT03062722, 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 23 Feb 2017.