Carpal Tunnel SyndromeNCT01887145
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
A study testing Endoscopic surgery and Open surgery in people with Carpal Tunnel Syndrome, run by Region Skane.
Trial summary
No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Endoscopic surgery and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jan 2015
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary idiopathic carpal tunnel syndrome
- age 25-60 years
- currently employed
- duration of symptoms of at least three months
- inadequate response to six weeks' treatment with wrist splint
- symptoms of classic or probable carpal tunnel syndrome according to the diagnostic criteria in the Katz hand diagram, and nerve conduction test showing median neuropathy at the wrist (distal motor latency ≥4.5 milliseconds, wrist-digit sensory latency ≥3.5 milliseconds, or sensory conduction velocity at the carpal tunnel segment <40 metres/second but no other abnormalities.
Who cannot join
- Inflammatory joint disease
- diabetes mellitus, thyroid disorder, pregnancy, trauma to the affected hand during the preceding year
- previous carpal tunnel release surgery in the affected hand
- carpal tunnel release surgery in the contralateral hand during the preceding year
- symptoms of carpal tunnel syndrome in the contralateral hand not adequately relieved by splint at the time of enrollment
- current sick leave because of disorders other than carpal tunnel syndrome
- inability to complete questionnaires because of language problem or cognitive disorder.
About this study
Official title: Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial
No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS. The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively. The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent. This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by mail to the patients. The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction. The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial. The completed questionnaires will be scanned into a database. The scores for the different scales will be calculated. Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Endoscopic surgery, Open surgery
- Keywords
- Carpal tunnel syndrome, Surgery, Outcomes
- 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.
Endoscopic surgeryProcedure or surgery
Also called Endoscopic carpal tunnel release surgery
Surgery dwas done under local anesthesia injected at the portal sites only. Tourniquet was used. Each of the two skin incisions in the endoscopic procedure was 1 cm long. With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge. Incisions were closed with non-absorbables sutures and a soft dressing was applied. Sutures were removed 10 days postoperatively.
Open surgeryProcedure or surgery
Also called Open carpal tunnel release surgery
Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet. The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease. The transverse carpal ligament was divided; no additional procedures were performed. a soft dressing was applied. Dressing and sutures were removed 10 days postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Open surgery | Active comparator | Open surgery is Open carpal tunnel release Receives: Procedure: Open surgery |
| Endoscopic surgery | Experimental | Endoscopic surgery is 2-portal endoscopic carpal tunnel release Receives: Procedure: Endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CTS symptom severity score
Measured: Baseline to 10-15 years postoperatively
Secondary outcomes (5)
Rate of repeat surgery
Measured: 10-15 years postoperatively
Change in CTS functional status score
Measured: from baseline and 1 year to 10-15 years postoperatively
Residual pain in the scar or proximal palm
Measured: 10-15 years postoperatively
Patient satisfaction with the results of surgery
Measured: 10-15 years postoperatively
Change in CTS symptom severity score
Measured: 1 year to 10-15 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionJan 2015
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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isam Atroshi, MD, PhD, Principal investigator, Clinical Sciences, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887145
- Sponsor's protocol ID
- HLM-CTSRCT-2
- Status last verified
- May 2015
- First submitted
- 24 Jun 2013
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.
PubMed 16777857Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available.
PubMed 26441187
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01887145
- Acronym / sponsor ID
- HLM-CTSRCT-2
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, Surgery, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Jun 2013 (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.
No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS. The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively. The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent. This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by mail to the patients. The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction. The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial. The completed questionnaires will be scanned into a database. The scores for the different scales will be calculated. Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgery | Active comparator | Procedure: Open surgeryOpen surgery is Open carpal tunnel release |
| Endoscopic surgery | Experimental | Procedure: Endoscopic surgeryEndoscopic surgery is 2-portal endoscopic carpal tunnel release |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primary idiopathic carpal tunnel syndrome
- age 25-60 years
- currently employed
- duration of symptoms of at least three months
- inadequate response to six weeks' treatment with wrist splint
Key exclusion criteria (7 listed)
- Inflammatory joint disease
- diabetes mellitus, thyroid disorder, pregnancy, trauma to the affected hand during the preceding year
- previous carpal tunnel release surgery in the affected hand
- carpal tunnel release surgery in the contralateral hand during the preceding year
- symptoms of carpal tunnel syndrome in the contralateral hand not adequately relieved by splint at the time of enrollment
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 |
|---|---|---|
| Endoscopic surgeryAlso: Endoscopic carpal tunnel release surgerySurgery dwas done under local anesthesia injected at the portal sites only. Tourniquet was used. Each of the two skin incisions in the endoscopic procedure was 1 cm long. With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge. Incisions were closed with non-absorbables sutures and a soft dressing was applied. Sutures were removed 10 days postoperatively. | Procedure or surgery | Endoscopic surgery |
| Open surgeryAlso: Open carpal tunnel release surgeryOpen carpal tunnel release using conventional open technique under local anesthesia and tourniquet. The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease. The transverse carpal ligament was divided; no additional procedures were performed. a soft dressing was applied. Dressing and sutures were removed 10 days postoperatively. | Procedure or surgery | Open surgery |
Primary outcome
Change in CTS symptom severity score
Time frame: Baseline to 10-15 years postoperatively
5 secondary outcomes
Rate of repeat surgery
Time frame: 10-15 years postoperatively
Change in CTS functional status score
Time frame: from baseline and 1 year to 10-15 years postoperatively
Residual pain in the scar or proximal palm
Time frame: 10-15 years postoperatively
Patient satisfaction with the results of surgery
Time frame: 10-15 years postoperatively
Change in CTS symptom severity score
Time frame: 1 year to 10-15 years postoperatively
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 6 May 2015.
- Background: PubMed 16777857Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.
- Derived from this study: PubMed 26441187Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available.
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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.
Isam Atroshi, MD, PhD principal investigator
Clinical Sciences, Lund University, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic surgery and Open surgery in people with Carpal Tunnel Syndrome, run by Region Skane.
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 6 inclusion and 7 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 6 May 2015. 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?
Change in CTS symptom severity score (time frame: Baseline to 10-15 years postoperatively). 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 NCT01887145, 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 6 May 2015.