Carpal Tunnel Syndrome (CTS)FOCUSNCT06934187
Carpal Tunnel Release Efficacy Trial
A study testing Carpal tunnel release in people with Carpal Tunnel Syndrome (CTS) and Carpal Tunnel Surgery, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Background Carpal tunnel syndrome (CTS) is a prevalent condition that affects 2.7% of the population, especially women. It arises due to compression of the median nerve in the wrist and is linked to factors like diabetes, obesity, and physical workload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Carpal Tunnel Surgery
- What is being tested?
- Carpal tunnel release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2026to Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CTS diagnosed with ENMG, Symptoms typical for CTS, Ability to understand and answer the questionnaires, ≥ 18 years old.
Who cannot join
- Recurrent CTS; Ongoing systematic steroid treatment, chemotherapy, or immunomodulatory treatment; Pregnancy or breast feeding; Intrinsic muscle atrophy; Peripheral neuropathies; and Profound cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Kuopio University Hospital
Kuopio, Northern Savonia, 70200
Mikko P Räisänen, MD, +358503763994, mikko.raisanen@pshyvinvointialue.fi
About this study
Official title: eFficacy Of Carpal tUnnel releaSe (FOCUS) - Protocol for Randomised Controlled Multicentre Triple-Blinded Placebo Surgery Carpal Tunnel Release Trial With Observational Group
Background Carpal tunnel syndrome (CTS) is a prevalent condition that affects 2.7% of the population, especially women. It arises due to compression of the median nerve in the wrist and is linked to factors like diabetes, obesity, and physical workload. Non-surgical treatments such as splinting and corticosteroid injections are often the first approach for mild to moderate CTS but show mixed long-term results. Surgical intervention, carpal tunnel release (CTR), is frequently necessary and has a success rate of 75-88%. CTR is a safe procedure, but like any surgery, it carries risks, including scarring and nerve injury.
Rationale Despite its widespread use, the effectiveness of CTR surgery has not been rigorously tested through randomised controlled trials (RCT) against placebo. This leaves a critical gap in understanding whether observed improvements result from surgery or the natural course of CTS, which can sometimes resolve on its own. Previous RCT in hand surgery have faced methodological issues, emphasising the need for high-quality research to validate the benefits of CTR surgery.
Read more
Objectives
FOCUS (eFficacy Of Carpal tUnnel release) trial, aims to provide robust evidence of CTR's effectiveness compared to placebo. The null and alternative hypotheses of the trial are as follows:
- Null Hypothesis: The treatment effect of CTR is not superior to placebo surgery.
- Alternative Hypothesis: The treatment effect of CTR is superior to placebo surgery
Trial Design This multinational, triple-blinded RCT includes two groups: one receiving CTR and the other undergoing placebo surgery. An additional observational cohort will enhance the trial's generalisability. Recruitment begins in Finland, with plans to expand to Denmark, China and Australia. Experienced hand surgeons will perform all procedures, and the study adheres to rigorous international guidelines (SPIRIT).
Methods Eligible participants are screened and randomised 1:1 to receive either CTR or placebo surgery. In CTR, surgeons relieve pressure on the median nerve through a small incision. Placebo surgery involves a similar incision without addressing the nerve compression. Both procedures use the same pre- and post-operative care protocols to maintain participant blinding.
Data collection involves comprehensive patient assessments at six months, one, two, and five years. A validated tool, the 6-CTS scale, is the primary outcome measure, while secondary measures include nerve conduction tests, hand strength, and patient-reported satisfaction.
The study includes 96 participants, allowing for statistical analysis with 80% power to detect meaningful differences in outcomes.Trial is triple-blinded ensuring that participants, outcome assessors, and investigators remain unaware of treatment assignments, minimising bias. Patients will be randomly assigned to 1:1 parallel groups using an internet-based randomisation program.
Ethical considerations The trial complies with the Declaration of Helsinki and national regulations. Participants provide informed consent and can withdraw at any time.
Data Management and Safety Data is securely stored in compliance with GDPR, and interim analyses are conducted to monitor safety. An independent Data Safety and Monitoring Committee (DSMC) oversees the trial, reviewing any serious adverse events.
Expected Outcomes and Significance
Discussion The trial seeks to determine whether CTR surgery provides superior outcomes compared to placebo, addressing a critical gap in evidence for this common procedure. By including patient-reported outcomes and rigorous blinding, the study emphasises improvements that matter most to individuals with CTS.
This research has far-reaching implications for patients, surgeons, and policymakers, offering insights into the value of CTR surgery. The results could refine treatment guidelines, ensuring that surgical interventions are evidence-based and benefit those most in need.
Conclusion The FOCUS-trial represents a significant step forward in validating the effectiveness of CTR surgery. By setting a high standard for surgical research, it aims to provide clarity on a widely performed procedure, contributing to improved care and outcomes for individuals with CTS worldwide.
- Being tested
- Carpal tunnel release, Placebo surgery
- Keywords
- Carpal tunnel syndrome, Carpal tunnel release, Placebo surgery, Sham surgery, Randomized controlled trial
- 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 releaseProcedure or surgery
The operating surgeons will make a skin incision distally from the distal wrist crease and ulnar to the thenar crease. The appropriate tissues, including the subcutaneous tissue, palmar fascia, flexor retinaculum, and antebrachial fascia, will then be divided in CTR group. Haemostasis will be achieved using bipolar coagulation. The skin will be closed, and an appropriate dressing will be applied.
Placebo surgeryProcedure or surgery
Only an skin incision will be made and the same time as CTR operation takes will be waited until skin closure. An appropriate dressing will be applied.
| Study group | Role | What they receive |
|---|---|---|
| CTR surgery | Active comparator | Carpal tunnel release will be performed. Receives: Procedure: Carpal tunnel release |
| Placebo surgery | Placebo comparator | Only skin incision will be performed. Receives: Procedure: Placebo surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTS-6
The 6-item Carpal Tunnel Syndrome Symptoms Scale questionnaire (6-CTS) is a CTS-specific instrument addressing pain and numbness in daily living. 6-CTS gives a value between 1 (best) and 5 (worst).
Measured: Preoperative vs 1 year. Secondary time points 6 months, 2 years and 5 years
Secondary outcomes (9)
ENMG
Electroneuromyography (ENMG) has been adopted as a standard procedure when diagnosing CTS, and it can help to track improvements in nerve conduction postoperatively.
Measured: Preoperatively and 1 year
EQ-5D-3L
EuroQoL 5-Dimension 3-Level (EQ-5D-3L) is a Quality-of-Life assessment tool, validated in multiple languages. Scores value usually between 1.00 (perfect health) and 0 (death), but a minimum value obtainable is -0.594 (health condition worse than death). Higher score is better.
Measured: Preoperatively, 6 months, 1 year, 2 years, 5 years
VAS for pain
Visual analogue scale (VAS) has been validated for pain evaluation. Values range from 0 to 100mm, higher is worse.
Measured: Preoperative, 6 months, 1 year, 2 years, 5 years
VAS for nocturnal numbness
Visual analogue scale (VAS) has been used for evaluation of numbness after CTR. Values range from 0 to 100mm, higher is worse.
Measured: Preoperative, 6 months, 1 year, 2 years, 5 years
2-PD
Two-point discrimination (2-PD) has been shown to improve after CTR.
Measured: Preoperatively, 6 months, 1 year
Grip, tripod grasp, and pinch strength
Grip, tripod, and pinch strength have been shown to increase after CTR
Measured: Preoperatively, 6 months, 1 year
Willingness for a re-treatment
Willingness for a re-treatment will be assessed using the question: ""Would you prefer the same treatment again, if the result would be the same as it is now?" Possible answers are "Yes" and "No". Yes is a better answer and No is a worse answer.
Measured: 1 year
Global rating
Patient-rated global improvement will be assessed using the question: "How would you rate the function and pain of your hand compared to the situation before the treatment?" Participants will provide responses on a 7-step Likert scale, ranging from "Much worse" to "Much better."
Measured: Preoperatively, 6 months, 1 year, 2 years, 5 years
Adverse events
Adverse events will be recorded and monitored.
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Model description
- This trial is a multicentre, multinational, randomised, controlled, triple-blinded superiority trial with 1:1 parallel groups. Participants in one group will undergo carpal tunnel release while those in the other group will undergo placebo surgery.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Susanna B Hiltunen, MD, Principal investigator, Wellbeing services county of North Savo, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934187
- Sponsor's protocol ID
- 89/2024
- Acronym
- FOCUS
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymised patient level data can be shared within the EU/ETA. Anonymous patient level data will be available globally. These include all gathered data. Data will be shared after the trial has been finished.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eFficacy Of Carpal tUnnel releaSe (FOCUS) - Protocol for Randomised Controlled Multicentre Triple-Blinded Placebo Surgery Carpal Tunnel Release Trial With Observational Group
- ClinicalTrials.gov ID
- NCT06934187
- Acronym / sponsor ID
- FOCUS / 89/2024
- Keywords
- Carpal tunnel syndrome, Carpal tunnel release, Placebo surgery, Sham surgery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 18 Apr 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.
Background Carpal tunnel syndrome (CTS) is a prevalent condition that affects 2.7% of the population, especially women. It arises due to compression of the median nerve in the wrist and is linked to factors like diabetes, obesity, and physical workload. Non-surgical treatments such as splinting and corticosteroid injections are often the first approach for mild to moderate CTS but show mixed long-term results. Surgical intervention, carpal tunnel release (CTR), is frequently necessary and has a success rate of 75-88%. CTR is a safe procedure, but like any surgery, it carries risks, including scarring and nerve injury.
Rationale Despite its widespread use, the effectiveness of CTR surgery has not been rigorously tested through randomised controlled trials (RCT) against placebo. This leaves a critical gap in understanding whether observed improvements result from surgery or the natural course of CTS, which can sometimes resolve on its own. Previous RCT in hand surgery have faced methodological issues, emphasising the need for high-quality research to validate the benefits of CTR surgery.
Objectives
FOCUS (eFficacy Of Carpal tUnnel release) trial, aims to provide robust evidence of CTR's effectiveness compared to placebo. The null and alternative hypotheses of the trial are as follows:
- Null Hypothesis: The treatment effect of CTR is not superior to placebo surgery.
- Alternative Hypothesis: The treatment effect of CTR is superior to placebo surgery
Trial Design This multinational, triple-blinded RCT includes two groups: one receiving CTR and the other undergoing placebo surgery. An additional observational cohort will enhance the trial's generalisability. Recruitment begins in Finland, with plans to expand to Denmark, China and Australia. Experienced hand surgeons will perform all procedures, and the study adheres to rigorous international guidelines (SPIRIT).
Methods Eligible participants are screened and randomised 1:1 to receive either CTR or placebo surgery. In CTR, surgeons relieve pressure on the median nerve through a small incision. Placebo surgery involves a similar incision without addressing the nerve compression. Both procedures use the same pre- and post-operative care protocols to maintain participant blinding.
Data collection involves comprehensive patient assessments at six months, one, two, and five years. A validated tool, the 6-CTS scale, is the primary outcome measure, while secondary measures include nerve conduction tests, hand strength, and patient-reported satisfaction.
The study includes 96 participants, allowing for statistical analysis with 80% power to detect meaningful differences in outcomes.Trial is triple-blinded ensuring that participants, outcome assessors, and investigators remain unaware of treatment assignments, minimising bias. Patients will be randomly assigned to 1:1 parallel groups using an internet-based randomisation program.
Ethical considerations The trial complies with the Declaration of Helsinki and national regulations. Participants provide informed consent and can withdraw at any time.
Data Management and Safety Data is securely stored in compliance with GDPR, and interim analyses are conducted to monitor safety. An independent Data Safety and Monitoring Committee (DSMC) oversees the trial, reviewing any serious adverse events.
Expected Outcomes and Significance
Discussion The trial seeks to determine whether CTR surgery provides superior outcomes compared to placebo, addressing a critical gap in evidence for this common procedure. By including patient-reported outcomes and rigorous blinding, the study emphasises improvements that matter most to individuals with CTS.
This research has far-reaching implications for patients, surgeons, and policymakers, offering insights into the value of CTR surgery. The results could refine treatment guidelines, ensuring that surgical interventions are evidence-based and benefit those most in need.
Conclusion The FOCUS-trial represents a significant step forward in validating the effectiveness of CTR surgery. By setting a high standard for surgical research, it aims to provide clarity on a widely performed procedure, contributing to improved care and outcomes for individuals with CTS worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a multicentre, multinational, randomised, controlled, triple-blinded superiority trial with 1:1 parallel groups. Participants in one group will undergo carpal tunnel release while those in the other group will undergo placebo surgery.
| Arm | Type | Receives |
|---|---|---|
| CTR surgery | Active comparator | Procedure: Carpal tunnel releaseCarpal tunnel release will be performed. |
| Placebo surgery | Placebo comparator | Procedure: Placebo surgeryOnly skin incision will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CTS diagnosed with ENMG, Symptoms typical for CTS, Ability to understand and answer the questionnaires, ≥ 18 years old.
Key exclusion criteria (1 listed)
- Recurrent CTS; Ongoing systematic steroid treatment, chemotherapy, or immunomodulatory treatment; Pregnancy or breast feeding; Intrinsic muscle atrophy; Peripheral neuropathies; and Profound cognitive impairment
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 releaseThe operating surgeons will make a skin incision distally from the distal wrist crease and ulnar to the thenar crease. The appropriate tissues, including the subcutaneous tissue, palmar fascia, flexor retinaculum, and antebrachial fascia, will then be divided in CTR group. Haemostasis will be achieved using bipolar coagulation. The skin will be closed, and an appropriate dressing will be applied. | Procedure or surgery | CTR surgery |
| Placebo surgeryOnly an skin incision will be made and the same time as CTR operation takes will be waited until skin closure. An appropriate dressing will be applied. | Procedure or surgery | Placebo surgery |
Primary outcome
CTS-6
Time frame: Preoperative vs 1 year. Secondary time points 6 months, 2 years and 5 years
The 6-item Carpal Tunnel Syndrome Symptoms Scale questionnaire (6-CTS) is a CTS-specific instrument addressing pain and numbness in daily living. 6-CTS gives a value between 1 (best) and 5 (worst).
9 secondary outcomes
ENMG
Time frame: Preoperatively and 1 year
EQ-5D-3L
Time frame: Preoperatively, 6 months, 1 year, 2 years, 5 years
VAS for pain
Time frame: Preoperative, 6 months, 1 year, 2 years, 5 years
VAS for nocturnal numbness
Time frame: Preoperative, 6 months, 1 year, 2 years, 5 years
2-PD
Time frame: Preoperatively, 6 months, 1 year
Grip, tripod grasp, and pinch strength
Time frame: Preoperatively, 6 months, 1 year
Willingness for a re-treatment
Time frame: 1 year
Global rating
Time frame: Preoperatively, 6 months, 1 year, 2 years, 5 years
Adverse events
Time frame: 6 months, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. Pseudonymised patient level data can be shared within the EU/ETA. Anonymous patient level data will be available globally. These include all gathered data. Data will be shared after the trial has been finished.
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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.
Susanna B Hiltunen, MD principal investigator
Wellbeing services county of North Savo, Kuopio University Hospital
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 in people with Carpal Tunnel Syndrome (CTS) and Carpal Tunnel Surgery, run by Kuopio University Hospital at 1 site 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 1 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: opening soon, as of the sponsor's last update on 19 Sep 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 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikko P Räisänen, MD (+358503763994, mikko.raisanen@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTS-6 (time frame: Preoperative vs 1 year. Secondary time points 6 months, 2 years and 5 years). 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 19 Sep 2025.