Carpal Tunnel SyndromePhase 3NCT01017471
Carpal Tunnel Syndrome Release Using PSU Retractor
A Phase 3 study testing Limited incision using PSU retractor in people with Carpal Tunnel Syndrome, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision. The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Limited incision using PSU retractor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 3
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months
Who cannot join
- Underlying disease such as : DM, neuropathy
- Previous wrist or hand surgery in the same side
- Previous wrist and hand trauma
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision.
The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Limited incision using PSU retractor
- Keywords
- carpal tunnel syndrome, surgery, PSU retractor, carpal tunnel syndrome who failed to conservative treatment
- 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.
Limited incision using PSU retractorProcedure or surgery
carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | carpal tunnel release using standard incision Receives: Procedure: Limited incision using PSU retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTS score
Measured: 1 year
Secondary outcomes (4)
VAS score
Measured: 1 year
return to work time
Measured: 1 year
satisfaction score
Measured: 1 year
complication rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonsin Tangtrakulwanich, Prince of Songkla University
- Investigators
- Sunthorn Wongsiri, MD, Principal investigator, Prince of Songkla University, Hatyai, Songkhla, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017471
- Sponsor's protocol ID
- 52-169-11-4-2
- Status last verified
- May 2012
- First submitted
- 17 Nov 2009
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01017471
- Acronym / sponsor ID
- 52-169-11-4-2
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, surgery, PSU retractor, carpal tunnel syndrome who failed to conservative treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Nov 2009 (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 investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision.
The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Procedure: Limited incision using PSU retractorcarpal tunnel release using standard incision |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months
Key exclusion criteria (4 listed)
- Underlying disease such as : DM, neuropathy
- Previous wrist or hand surgery in the same side
- Previous wrist and hand trauma
- Pregnancy
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 |
|---|---|---|
| Limited incision using PSU retractorcarpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons | Procedure or surgery | control |
Primary outcome
CTS score
Time frame: 1 year
4 secondary outcomes
VAS score
Time frame: 1 year
return to work time
Time frame: 1 year
satisfaction score
Time frame: 1 year
complication rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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.
Sunthorn Wongsiri, MD principal investigator
Prince of Songkla University, Hatyai, Songkhla, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Limited incision using PSU retractor in people with Carpal Tunnel Syndrome, run by Prince of Songkla University at 1 site in Thailand.
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 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 15 May 2012. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
CTS score (time frame: 1 year). 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 15 May 2012.