Carpal Tunnel SyndromeNCT00981565
Mild Carpal Tunnel Syndrome
A study testing open carpal tunnel release and Night-cast in people with Carpal Tunnel Syndrome, run by North Karelia Central Hospital at 3 sites in Finland.
Trial summary
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- open carpal tunnel release and Night-cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesFinland
- Study dates
- Sep 2009to Jun 2012
- 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
- electrophysiologically proven minimal or mild CTS lasting more than six months will be included in this study
Who cannot join
- rheumatoid arthritis
- diabetes mellitus
- hypothyreosis
- pregnancy
- wrist trauma or previous surgery
- splinting or corticosteroid injection on the affected side
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
North-Carelia Central Hospital
Joensuu
Kuopio University Hospital
Kuopio
Central Hospital of Mikkeli
Mikkeli
About this study
Official title: Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described.
Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not been done and it is still unclear whether or not surgical treatment is better than conservative treatment.
The aim of this study is to research has surgery better outcome in mild CTS than conservative treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and indirect costs will be evaluated.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- open carpal tunnel release, Night-cast
- Keywords
- Carpal tunnel syndrome, CTS, medianus impingement
- 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.
open carpal tunnel releaseProcedure or surgery
surgery to release the carpal tunnel
Night-castOther
individual night time splinting
| Study group | Role | What they receive |
|---|---|---|
| Operative | Active comparator | Not described Receives: Procedure: open carpal tunnel release |
| Conservative | Active comparator | Not described Receives: Other: Night-cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Severity Score
Measured: 1 year
Pain Visual Analogue Scale (VAS)
Measured: 1 year
Secondary outcomes (1)
Change in electroneuromyography
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 posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionJun 2012
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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Kouhia, North Karelia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981565
- Sponsor's protocol ID
- NKCH-Surg-005
- Status last verified
- Oct 2012
- First submitted
- 11 Sep 2009
- Last updated
- 18 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT00981565
- Acronym / sponsor ID
- NKCH-Surg-005
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, CTS, medianus impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Sep 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.
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described.
Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not been done and it is still unclear whether or not surgical treatment is better than conservative treatment.
The aim of this study is to research has surgery better outcome in mild CTS than conservative treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and indirect costs will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative | Active comparator | Procedure: open carpal tunnel release |
| Conservative | Active comparator | Other: Night-cast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- electrophysiologically proven minimal or mild CTS lasting more than six months will be included in this study
Key exclusion criteria (6 listed)
- rheumatoid arthritis
- diabetes mellitus
- hypothyreosis
- pregnancy
- wrist trauma or previous 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 |
|---|---|---|
| open carpal tunnel releasesurgery to release the carpal tunnel | Procedure or surgery | Operative |
| Night-castindividual night time splinting | Other | Conservative |
Primary outcome
Change in Symptom Severity Score
Time frame: 1 year
Pain Visual Analogue Scale (VAS)
Time frame: 1 year
1 secondary outcome
Change in electroneuromyography
Time frame: 1 year
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 18 Oct 2012.
Related trials for Carpal Tunnel Syndrome
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Not yet recruitingObservational study
Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS)
Not yet recruiting
Effectiveness of Sensorimotor Proprioceptive Stimulation Combined With Conventional Physical Therapy on Symptoms, Sensory Function, Proprioception, and Hand Function in Patients With Mild-to-Moderate Carpal Tunnel Syndrome
Carpel Tunnel Syndrome
Recruiting
Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome
Carpal Tunnel Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open carpal tunnel release and Night-cast in people with Carpal Tunnel Syndrome, run by North Karelia Central Hospital at 3 sites in Finland.
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 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 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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?
Change in Symptom Severity Score (time frame: 1 year). 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 18 Oct 2012.