Carpal Tunnel SyndromeNCT06114823
Comparing a Modified Mini-incision Approach Versus the Conventional Approach for Carpal Tunnel Release
A study testing carpal tunnel release mini-incision and carpal tunnel release conventional incision in people with Carpal Tunnel Syndrome and Incision, run by Mansoura University at 1 site in Egypt.
Trial summary
Carpal tunnel syndrome (CTS) is the commonest nerve compression syndrome in the upper limbs, and carpal tunnel decompression is one of the most prevalent upper limb surgical interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Incision
- What is being tested?
- carpal tunnel release mini-incision and carpal tunnel release conventional incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 30 Nov 2022
- 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 primary CTS attending Mansoura university hospitals with EMG-and NCS-proved median neuropathy at the wrist.
- Failed conservative treatment.
- Absence of any other hand pathology.
- Positive Tinel sign presented at the site of nerve entrapment (the carpal tunnel at the wrist for the median nerve).
- Signed informed consent.
Who cannot join
- Presence of proximal radiculopathy.
- Previous history of cervical spondylosis.
- Inflammatory joint disease and gout.
- Presence of combined nerve compression.
- Having a previous hand or upper extremity surgery.
- Patients with incomplete follow-up data were also excluded from this study.
- Psychiatric disease or any other condition that is at risk of being influenced by the study or that might have affected completion of the study.
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fuclty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 0020
About this study
Official title: Randomized Control Trial Comparing the Outcome of a Modified Mini-incision Approach Versus the Conventional Approach for Carpal Tunnel Release
Carpal tunnel syndrome (CTS) is the commonest nerve compression syndrome in the upper limbs, and carpal tunnel decompression is one of the most prevalent upper limb surgical interventions. Surgeries for CTS may be more effective compared to conservative measures in reducing symptoms and improving hand function, particularly in patients with severe CTS.
The etiology of CTS is multifactorial and includes occupational and personal factors. Physical workload factors play an important role in CTS but the role of some personal factors is less clear. Obesity is a well-documented risk factor for CTS. Hypothyroidism, diabetes mellitus, rheumatoid arthritis and osteoarthritis are possible risk factors for CTS. Finally, the role of smoking in CTS is uncertain.
Read more
Traditional approach makes use of a longitudinal skin incision from the palm toward the wrist and across the transverse carpal ligament. Though this approach offers excellent visualization, reliable release of the full retinaculum, and ability to identify anatomic variations, it is associated with some intractable complications, including wound pain, scar tenderness, flexor tendon entrapment and thenar as well as hypothenar (pillar) pain, which are difficult to recovery.
The attempt to perform CTR without extra complications leads to the development of different techniques and several mini-incision approaches.
These techniques help to reduce incisional discomfort after surgery, but it can lead to frequent incidence of blood vessel injury or incomplete release. The mini-incision approaches have the advantage of leaving a smaller scar, less scar pain, and lower grade of pillar pain. Though several methods have been proposed, there were still some disadvantages in them. Though CTR can be safely accomplished by them, incomplete release still occurred in several cases for some reasons.
After intensive research in the current literature, there is a paucity of studies evaluating the efficacy and safety of mini-incision approaches in achieving CTR in Egyptian patients. That is why we conducted the present study to present our experience with the modified mini-incision technique and compare its outcomes to the conventional open approach.
Read the detailed description
All selected cases with primary CTS will be submitted to:
- Preoperative evaluation:
A- Careful history taking: Brief history based on the characteristics of pain, sensory disturbances including numbness, tingling, and/or weakness involving the median nerve distribution. Patients were additionally inquired about their functional status, normal activities, ability to work, family history of diabetes and the use of medications.
B- The visual analogue scale (VAS) (0= no pain to 10= worst possible pain), will be used to assess the severity of diabetic neuropathic pain.
C- Neurosensory examination mainly included percussion over a distribution of the affected peripheral nerve (Tinel sign) and two-point discrimination (2-PD) using the Disk-Criminator.
D- Nerve conduction velocity (NCV).
II) Surgical Technique:
All patients are positioned on the operating table in supine position and anesthetized with local anaesthesia.
- For the conventional approach: a palmar longitudinal incision began at the axis of the ring finger, passed between the thenar and hypothenar eminences, and continued proximally to the proximal flexor crease of the wrist. After exposing the underlying transverse carpal ligament, its ulnar side was cut longitudinally. The median nerve was identified and protected, and then the wound was closed in routine manner.
- For the new mini-incision approach: a special metal guide with a groove at the center is used. The incision is started above the proximal flexor crease of the wrist and is advanced proximally for 1.5-2.0 cm. After opening the superficial fascia, blunt dissection with a mosquito clamp is performed till the median nerve appears and the guide is inserted into the carpal tunnel, then a scissor is inserted along the groove in the guide and the transverse carpal ligament is cut proximally and distally.
III) Postoperative follow up:
The follow-up was conducted mainly on an outpatient basis comparing the postoperative outcome in both groups as regard improvement of symptoms, postoperative complications, scar effect and recurrence of symptoms. Patients will be followed up at 2 weeks, 1 month, 3 months, and 6 months post decompression.
- Conditions
- Carpal Tunnel Syndrome, Incision
- Being tested
- carpal tunnel release mini-incision, carpal tunnel release conventional incision
- Medical subject headings
- Carpal Tunnel Syndrome, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carpal tunnel release mini-incisionProcedure or surgery
Patients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction
carpal tunnel release conventional incisionProcedure or surgery
Patients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease.
| Study group | Role | What they receive |
|---|---|---|
| mini incision group | Active comparator | Patients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction. Receives: Procedure: carpal tunnel release mini-incision; Procedure: carpal tunnel release conventional incision |
| conventional group | Active comparator | Patients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease. Receives: Procedure: carpal tunnel release mini-incision; Procedure: carpal tunnel release conventional incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in carpal tunnel syndrome associated pain
According to visual analogue scale for pain which consists of 10 items , 0 for no pain and 10 for the maximum pain.
Measured: 6 months postoperative
Secondary outcomes (4)
pillar pain
According to visual analogue scale for pain which consists of 10 items , 0 for no pain or good outcome and 10 for the maximum pain or bad outcome.
Measured: 1,3&6 months postoperative
recurrence of neuropathic symptoms
According to visual analogue scale for pain which consists of 10 items , 0 for no pain or good outcome and 10 for the maximum pain or bad outcome.
Measured: it will be evaluated till 6 months postoperative
operative time
From skin incision which is the start of the surgery ,till the end of the procedure
Measured: from start till the end of the operation
scar effect
this item will measure the patients satisfaction for the skin scar as a cosmetic outcome, using the SCAR-Q scale which has 3 independently functioning scales that measure scar appearance, scar symptoms and its psychosocial impact.
Measured: from surgery till 3,6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2021
- Primary completion31 Aug 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mostafa, Mansoura University
- Investigators
- mohamed mahmoud, MD, Principal investigator, Mansoura faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114823
- Sponsor's protocol ID
- 2345
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing the Outcome of a Modified Mini-incision Approach Versus the Conventional Approach for Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT06114823
- Acronym / sponsor ID
- 2345
- Conditions
- Carpal Tunnel Syndrome, Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Nov 2023 (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.
Carpal tunnel syndrome (CTS) is the commonest nerve compression syndrome in the upper limbs, and carpal tunnel decompression is one of the most prevalent upper limb surgical interventions. Surgeries for CTS may be more effective compared to conservative measures in reducing symptoms and improving hand function, particularly in patients with severe CTS.
The etiology of CTS is multifactorial and includes occupational and personal factors. Physical workload factors play an important role in CTS but the role of some personal factors is less clear. Obesity is a well-documented risk factor for CTS. Hypothyroidism, diabetes mellitus, rheumatoid arthritis and osteoarthritis are possible risk factors for CTS. Finally, the role of smoking in CTS is uncertain.
Traditional approach makes use of a longitudinal skin incision from the palm toward the wrist and across the transverse carpal ligament. Though this approach offers excellent visualization, reliable release of the full retinaculum, and ability to identify anatomic variations, it is associated with some intractable complications, including wound pain, scar tenderness, flexor tendon entrapment and thenar as well as hypothenar (pillar) pain, which are difficult to recovery.
The attempt to perform CTR without extra complications leads to the development of different techniques and several mini-incision approaches.
These techniques help to reduce incisional discomfort after surgery, but it can lead to frequent incidence of blood vessel injury or incomplete release. The mini-incision approaches have the advantage of leaving a smaller scar, less scar pain, and lower grade of pillar pain. Though several methods have been proposed, there were still some disadvantages in them. Though CTR can be safely accomplished by them, incomplete release still occurred in several cases for some reasons.
After intensive research in the current literature, there is a paucity of studies evaluating the efficacy and safety of mini-incision approaches in achieving CTR in Egyptian patients. That is why we conducted the present study to present our experience with the modified mini-incision technique and compare its outcomes to the conventional open approach.
Detailed description
All selected cases with primary CTS will be submitted to:
- Preoperative evaluation:
A- Careful history taking: Brief history based on the characteristics of pain, sensory disturbances including numbness, tingling, and/or weakness involving the median nerve distribution. Patients were additionally inquired about their functional status, normal activities, ability to work, family history of diabetes and the use of medications.
B- The visual analogue scale (VAS) (0= no pain to 10= worst possible pain), will be used to assess the severity of diabetic neuropathic pain.
C- Neurosensory examination mainly included percussion over a distribution of the affected peripheral nerve (Tinel sign) and two-point discrimination (2-PD) using the Disk-Criminator.
D- Nerve conduction velocity (NCV).
II) Surgical Technique:
All patients are positioned on the operating table in supine position and anesthetized with local anaesthesia.
- For the conventional approach: a palmar longitudinal incision began at the axis of the ring finger, passed between the thenar and hypothenar eminences, and continued proximally to the proximal flexor crease of the wrist. After exposing the underlying transverse carpal ligament, its ulnar side was cut longitudinally. The median nerve was identified and protected, and then the wound was closed in routine manner.
- For the new mini-incision approach: a special metal guide with a groove at the center is used. The incision is started above the proximal flexor crease of the wrist and is advanced proximally for 1.5-2.0 cm. After opening the superficial fascia, blunt dissection with a mosquito clamp is performed till the median nerve appears and the guide is inserted into the carpal tunnel, then a scissor is inserted along the groove in the guide and the transverse carpal ligament is cut proximally and distally.
III) Postoperative follow up:
The follow-up was conducted mainly on an outpatient basis comparing the postoperative outcome in both groups as regard improvement of symptoms, postoperative complications, scar effect and recurrence of symptoms. Patients will be followed up at 2 weeks, 1 month, 3 months, and 6 months post decompression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mini incision group | Active comparator | Procedure: carpal tunnel release mini-incision, Procedure: carpal tunnel release conventional incisionPatients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction. |
| conventional group | Active comparator | Procedure: carpal tunnel release mini-incision, Procedure: carpal tunnel release conventional incisionPatients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with primary CTS attending Mansoura university hospitals with EMG-and NCS-proved median neuropathy at the wrist.
- Failed conservative treatment.
- Absence of any other hand pathology.
- Positive Tinel sign presented at the site of nerve entrapment (the carpal tunnel at the wrist for the median nerve).
- Signed informed consent.
Key exclusion criteria (8 listed)
- Presence of proximal radiculopathy.
- Previous history of cervical spondylosis.
- Inflammatory joint disease and gout.
- Presence of combined nerve compression.
- Having a previous hand or upper extremity 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 |
|---|---|---|
| carpal tunnel release mini-incisionPatients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction | Procedure or surgery | conventional group, mini incision group |
| carpal tunnel release conventional incisionPatients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease. | Procedure or surgery | conventional group, mini incision group |
Primary outcome
improvement in carpal tunnel syndrome associated pain
Time frame: 6 months postoperative
According to visual analogue scale for pain which consists of 10 items , 0 for no pain and 10 for the maximum pain.
4 secondary outcomes
pillar pain
Time frame: 1,3&6 months postoperative
recurrence of neuropathic symptoms
Time frame: it will be evaluated till 6 months postoperative
operative time
Time frame: from start till the end of the operation
scar effect
Time frame: from surgery till 3,6 months postoperative
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 2 Nov 2023.
- 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.
mohamed mahmoud, MD principal investigator
Mansoura faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carpal tunnel release mini-incision and carpal tunnel release conventional incision in people with Carpal Tunnel Syndrome and Incision, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 8 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 2 Nov 2023. 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 Egypt. 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?
improvement in carpal tunnel syndrome associated pain (time frame: 6 months postoperative). 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 2 Nov 2023.