Carpal Tunnel SyndromeCTRNCT02500355
Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope
A study testing Carpal Tunnel Release via limited approaches, Carpal Tunnel Release via standard approach and Endoscopic Carpal Tunnel Release in people with Carpal Tunnel Syndrome, run by The Second Hospital of Qinhuangdao at 1 site in China.
Trial summary
Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under Endoscope. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Carpal Tunnel Release via limited approaches, Carpal Tunnel Release via standard approach and Endoscopic Carpal Tunnel Release
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Feb 2013
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CTR was established based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand (2003)
- Patients with moderate, severe, and very severe symptom.
Who cannot join
- Mild symptom.
- Finding had a ganglion based on preoperative ultrasound.
- Associated with infection, gout, or diabetes.
- Patients who discontinued intervention and lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carpal Tunnel Release With Partial Excision of the Flexor Retinaculum Through Two Small Incisions
Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under Endoscope.
Read the detailed description
Carpal tunnel syndrome (CTS) affects over 60 million people worldwide. If a regimen of conservative management has failed, surgical release of the median nerve is warranted. Numerous approaches for carpal tunnel release have been described that range from an open technique to a limited incision to endoscopic release. In addition, partial excision of the flexor retinaculum is advocated by some surgeons because of obtaining better outcomes. However, the procedure is difficult to be accomplished through small incisions owing to poor visualization. Currently, balance of incision, visualization, and partial excision of the flexor retinaculum is still controversial.
The objective of this report is to introduce carpal tunnel release with partial excision of the flexor retinaculum through two small incisions. The procedures were performed under lighted head magnifier. This is the first report on the use of our technique. For comparison, the investigators also included two other groups of standard open carpal tunnel release with partial excision of the flexor retinaculum and endoscopic carpal tunnel release without excision of the flexor retinaculum.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal Tunnel Release via limited approaches, Carpal Tunnel Release via standard approach, Endoscopic Carpal Tunnel Release, endoscope or an arthroscopic device
- 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.
Carpal Tunnel Release via limited approachesProcedure or surgery
Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.
Carpal Tunnel Release via standard approachProcedure or surgery
Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.
Endoscopic Carpal Tunnel ReleaseProcedure or surgery
Carpal tunnel release under endoscope.
endoscope or an arthroscopic deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Carpal Tunnel Release via limited approaches with 2 years follow-up. Receives: Procedure: Carpal Tunnel Release via limited approaches |
| Group B | Active comparator | Carpal Tunnel Release via standard approach with 2 years follow-up. Receives: Procedure: Carpal Tunnel Release via standard approach |
| Group C | Placebo comparator | Endoscopic Carpal Tunnel Release with 2 years follow-up. Receives: Procedure: Endoscopic Carpal Tunnel Release; Device: endoscope or an arthroscopic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of symptoms and functional status on Boston Questionnaire
Measured: 2 years
Secondary outcomes (1)
Grip strength
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Zhang, MD, Study chair, The Second Hospital of Qinhunangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500355
- Sponsor's protocol ID
- qhd20150712
- Acronym
- CTR
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Notarnicola A, Maccagnano G, Tafuri S, Fiore A, Pesce V, Moretti B. Comparison of shock wave therapy and nutraceutical composed of Echinacea angustifolia, alpha lipoic acid, conjugated linoleic acid and quercetin (perinerv) in patients with carpal tunnel syndrome. Int J Immunopathol Pharmacol. 2015 Jun;28(2):256-62. doi: 10.1177/0394632015584501. Epub 2015 May 7.
PubMed 25953494Aksekili MA, Bicici V, Isik C, Aksekili H, Ugurlu M, Dogan M. Comparison of early postoperative period electrophysiological and clinical findings following carpal tunnel syndrome: is EMG necessary? Int J Clin Exp Med. 2015 Apr 15;8(4):6267-71. eCollection 2015.
PubMed 26131237
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Release With Partial Excision of the Flexor Retinaculum Through Two Small Incisions
- ClinicalTrials.gov ID
- NCT02500355
- Acronym / sponsor ID
- CTR / qhd20150712
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jul 2015 (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.
Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under Endoscope.
Detailed description
Carpal tunnel syndrome (CTS) affects over 60 million people worldwide. If a regimen of conservative management has failed, surgical release of the median nerve is warranted. Numerous approaches for carpal tunnel release have been described that range from an open technique to a limited incision to endoscopic release. In addition, partial excision of the flexor retinaculum is advocated by some surgeons because of obtaining better outcomes. However, the procedure is difficult to be accomplished through small incisions owing to poor visualization. Currently, balance of incision, visualization, and partial excision of the flexor retinaculum is still controversial.
The objective of this report is to introduce carpal tunnel release with partial excision of the flexor retinaculum through two small incisions. The procedures were performed under lighted head magnifier. This is the first report on the use of our technique. For comparison, the investigators also included two other groups of standard open carpal tunnel release with partial excision of the flexor retinaculum and endoscopic carpal tunnel release without excision of the flexor retinaculum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Carpal Tunnel Release via limited approachesCarpal Tunnel Release via limited approaches with 2 years follow-up. |
| Group B | Active comparator | Procedure: Carpal Tunnel Release via standard approachCarpal Tunnel Release via standard approach with 2 years follow-up. |
| Group C | Placebo comparator | Procedure: Endoscopic Carpal Tunnel Release, Device: endoscope or an arthroscopic deviceEndoscopic Carpal Tunnel Release with 2 years follow-up. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of CTR was established based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand (2003)
- Patients with moderate, severe, and very severe symptom.
Key exclusion criteria (4 listed)
- Mild symptom.
- Finding had a ganglion based on preoperative ultrasound.
- Associated with infection, gout, or diabetes.
- Patients who discontinued intervention and lost to follow-up.
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 via limited approachesCarpal tunnel release with partial excision of the flexor retinaculum via two small incisions. | Procedure or surgery | Group A |
| Carpal Tunnel Release via standard approachCarpal tunnel release with partial excision of the flexor retinaculum via the standard incision. | Procedure or surgery | Group B |
| Endoscopic Carpal Tunnel ReleaseCarpal tunnel release under endoscope. | Procedure or surgery | Group C |
| endoscope or an arthroscopic device | Device | Group C |
Primary outcome
Severity of symptoms and functional status on Boston Questionnaire
Time frame: 2 years
1 secondary outcome
Grip strength
Time frame: 2 years
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 16 Jul 2015.
- Background: PubMed 25953494Notarnicola A, Maccagnano G, Tafuri S, Fiore A, Pesce V, Moretti B. Comparison of shock wave therapy and nutraceutical composed of Echinacea angustifolia, alpha lipoic acid, conjugated linoleic acid and quercetin (perinerv) in patients with carpal tunnel syndrome. Int J Immunopathol Pharmacol. 2015 Jun;28(2):256-62. doi: 10.1177/0394632015584501. Epub 2015 May 7.
- Results publication: PubMed 26131237Aksekili MA, Bicici V, Isik C, Aksekili H, Ugurlu M, Dogan M. Comparison of early postoperative period electrophysiological and clinical findings following carpal tunnel syndrome: is EMG necessary? Int J Clin Exp Med. 2015 Apr 15;8(4):6267-71. eCollection 2015.
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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.
Xu Zhang, MD study chair
The Second Hospital of Qinhunangdao
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 via limited approaches, Carpal Tunnel Release via standard approach and Endoscopic Carpal Tunnel Release in people with Carpal Tunnel Syndrome, run by The Second Hospital of Qinhuangdao at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 16 Jul 2015. 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 China. 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. Some participants in this study may receive a placebo. 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?
Severity of symptoms and functional status on Boston Questionnaire (time frame: 2 years). 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 NCT02500355, which also lists 2 linked publications.
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 16 Jul 2015.