Carpal Tunnel SyndromeNCT07018011
Comparison of Conventional Versus Transverse Mini-Incision Technique for Carpal Tunnel Release
A study testing Conventional open CTR and Transverse mini-incision technique in people with Carpal Tunnel Syndrome, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
This study aimed at to fill the gaps by comparing the surgical outcomes of the conventional versus transverse mini-incision technique for carpal tunnel syndrome in terms of pain and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Conventional open CTR and Transverse mini-incision technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 31 Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any genders
- Aged between 18 and 70 years
- Presenting with symptoms of carpal tunnel syndrome for at least 3 months duration, and having a VAS score > 4.
Who cannot join
- Patients with wrists with thenar atrophy
- Those who had previous CTR surgery
- Local injection for CTS
- Pregnant females
- Patients suffering from inflammatory arthropathy
- Polyneuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Conventional Versus Transverse Mini-Incision Technique for Carpal Tunnel Release: A Randomized Controlled Trial
This study aimed at to fill the gaps by comparing the surgical outcomes of the conventional versus transverse mini-incision technique for carpal tunnel syndrome in terms of pain and functional outcomes.
Read the detailed description
The study findings would be helpful in determining the superiority of one surgical technique over the other for carpal tunnel release so that a quicker return to normal activities and work for those patients could be achieved, causing less pain and scarring. Due to frequent healthcare visits, quality of life can also be improved along with a decrease in morbidity.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Conventional open CTR, Transverse mini-incision technique
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional open CTRProcedure or surgery
Conventional open CTR involved making a longitudinal incision in the wrist, typically along the median palmar crease, to access and release the transverse carpal ligament.
Transverse mini-incision techniqueProcedure or surgery
Mini-incision CTR involved a smaller incision than traditional CTR procedures, aiming to minimize scarring and improve recovery time.
| Study group | Role | What they receive |
|---|---|---|
| Conventional open CTR | Experimental | Conventional open CTR involved making a longitudinal incision in the wrist, typically along the median palmar crease, to access and release the transverse carpal ligament. Receives: Procedure: Conventional open CTR |
| Transverse mini-incision technique | Experimental | Mini-incision CTR involved a smaller incision than traditional CTR procedures, aiming to minimize scarring and improve recovery time. Receives: Procedure: Transverse mini-incision technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
A score percentage of 0-40 on the visual analog scale was graded as good, 50-60 as fair, and 70-100 as poor
Measured: 9 months
Functional outcome
On functional severity scale, a score percentage of 20-45% was graded as good, 46-60% was graded as fair, and 61-100% was graded as poor.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Apr 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kashif Raza, FCPS, Principal investigator, Sahiwal Teaching Hospital, SahiwalMuhammad Rashid, FCPS, Study director, Sahiwal Teaching Hospital, Sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018011
- Sponsor's protocol ID
- DRKASHIFSAHIWAL
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Versus Transverse Mini-Incision Technique for Carpal Tunnel Release: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07018011
- Acronym / sponsor ID
- DRKASHIFSAHIWAL
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Jun 2025 (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.
This study aimed at to fill the gaps by comparing the surgical outcomes of the conventional versus transverse mini-incision technique for carpal tunnel syndrome in terms of pain and functional outcomes.
Detailed description
The study findings would be helpful in determining the superiority of one surgical technique over the other for carpal tunnel release so that a quicker return to normal activities and work for those patients could be achieved, causing less pain and scarring. Due to frequent healthcare visits, quality of life can also be improved along with a decrease in morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional open CTR | Experimental | Procedure: Conventional open CTRConventional open CTR involved making a longitudinal incision in the wrist, typically along the median palmar crease, to access and release the transverse carpal ligament. |
| Transverse mini-incision technique | Experimental | Procedure: Transverse mini-incision techniqueMini-incision CTR involved a smaller incision than traditional CTR procedures, aiming to minimize scarring and improve recovery time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any genders
- Aged between 18 and 70 years
- Presenting with symptoms of carpal tunnel syndrome for at least 3 months duration, and having a VAS score > 4.
Key exclusion criteria (6 listed)
- Patients with wrists with thenar atrophy
- Those who had previous CTR surgery
- Local injection for CTS
- Pregnant females
- Patients suffering from inflammatory arthropathy
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 |
|---|---|---|
| Conventional open CTRConventional open CTR involved making a longitudinal incision in the wrist, typically along the median palmar crease, to access and release the transverse carpal ligament. | Procedure or surgery | Conventional open CTR |
| Transverse mini-incision techniqueMini-incision CTR involved a smaller incision than traditional CTR procedures, aiming to minimize scarring and improve recovery time. | Procedure or surgery | Transverse mini-incision technique |
Primary outcome
Pain severity
Time frame: 9 months
A score percentage of 0-40 on the visual analog scale was graded as good, 50-60 as fair, and 70-100 as poor
Functional outcome
Time frame: 9 months
On functional severity scale, a score percentage of 20-45% was graded as good, 46-60% was graded as fair, and 61-100% was graded as poor.
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 12 Jun 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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.
Kashif Raza, FCPS principal investigator
Sahiwal Teaching Hospital, Sahiwal
Muhammad Rashid, FCPS study director
Sahiwal Teaching Hospital, Sahiwal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional open CTR and Transverse mini-incision technique in people with Carpal Tunnel Syndrome, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 3 inclusion and 6 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 12 Jun 2025. 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 Pakistan. 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?
Pain severity (time frame: 9 months). The study lists 2 primary outcomes in all. 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 12 Jun 2025.