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Carpal Tunnel SyndromeFINCATSNCT07614425

Finnish Carpal Tunnel Surgery Study

A study testing Carpal tunnel release in people with Carpal Tunnel Syndrome, run by Helsinki University Central Hospital at 2 sites in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Carpal tunnel syndrome (CTS) is a common condition caused by pressure from a ligament on a nerve in the wrist, leading to pain, numbness, and weakness in the hand. Surgery to cut the ligament is often recommended when non-surgical treatments do not provide sufficient symptom relief, but it is unclear how much of the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Carpal tunnel release
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
2 sitesFinland
Study dates
11 Jun 2026to 31 Dec 2035
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years
  • Clinical manifestations of carpal tunnel syndrome: paresthesia and /or hypoesthesia in the distribution of the median nerve, possibly pain
  • Electrodiagnostically (ENMG or ENEG) verified compression of the median nerve at the carpal tunnel in the wrist, performed no more than a year before recruitment.
  • Duration of symptoms 3 months or longer
  • Patient living independently
  • Patient has not responded to the use of a resting splint supporting the wrist, nor to other possible conservative forms of treatment
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  • Patient able and willing to give consent
  • The patient is willing to undergo surgical treatment for carpal tunnel syndrome.
  • The patient has access to a device that can be used to complete electronic symptom questionnaires.

Who cannot join

  • Work disability
  • Clinical findings of Abductor Pollicis Brevis atrophy
  • Symptoms and Electrodiagnostic findings of some other peripheral neural entrapment than carpal tunnel syndrome
  • Rheumatoid arthritis or other forms of systemic inflammatory disease
  • Diagnosed dementia
  • Neurologic disorders affecting the function of the hand
Show all 11Show fewer
  • Other untreated systemic disorders or diseases with poor therapeutic balance: hypertension, epilepsy, pulmonary or cardiac disease, liver or renal insufficiency, diabetes mellitus, hypothyroidism, psychiatric disease
  • Other causes of pain and paresthesia in the hand
  • Previous trauma of the hand or wrist (e.g. distal radius fracture), which has resulted in compromised hand function
  • Previous carpal tunnel release in either hand
  • Previous nerve injury to the upper limb or cervical spine

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Susanna Stjernberg-Salmela, MD, PhD contact

0504274955 ext. +358

Susanna.Stjernberg-Salmela@hus.fi

Kati MJ Jaatinen contact

kati.jaatinen@hus.fi

Finland2 sites, 2 recruiting

  • HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital

    Helsinki

    Susanna Stjernberg-Salmela, MD, 0504274955 ext. +358, Susanna.Stjernberg-Salmela@hus.fi

    Saara Raatikainen, Saara.Raatikainen@hus.fi

    Recruiting

  • Wellbeing Services County of Pirkamaa, Tampere Central University Hospital

    Tampere

    Jarkko Jokihaara, Jarkko.Jokihaara@tuni.fi

    Teemu Karjalainen, Teemu.Karjalainen@pirha.fi

    Recruiting

Other trials in Finland

About this study

Official title: Finnish Carpal Tunnel Study - a Randomised, Placebo-surgery Controlled Trial

Carpal tunnel syndrome (CTS) is a common condition caused by pressure from a ligament on a nerve in the wrist, leading to pain, numbness, and weakness in the hand. Surgery to cut the ligament is often recommended when non-surgical treatments do not provide sufficient symptom relief, but it is unclear how much of the improvement is due to the surgery itself versus natural recovery or placebo effects.

The FINCATS study will compare standard carpal tunnel surgery with a placebo procedure in which the ligament is not cut. Participants and the healthcare staff caring for them after the procedure will not know which procedure was performed. The study's main question is whether cutting the ligament provides greater symptom relief than a placebo procedure. In addition, eligible patients who are not willing to participate in randomized setting are invited to join a parallel observational group. Participants in this observational group are treated within usual care pathway.

Participants in both the randomized and observational group will be followed for five years to assess symptom improvement, hand function, pain, quality of life, and any side effects. The goal is to provide reliable evidence to help patients and doctors make informed decisions about treatment.

Being tested
Carpal tunnel release, Placebo surgery
Keywords
Randomised controlled trial, Placebo-controlled trial, Surgery, Carpal tunnel syndrome, Carpal tunnel release
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

    Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

  • Placebo surgeryProcedure or surgery

    Skin incision and division of the palmar aponeurosis

Study groups in NCT07614425
Study groupRoleWhat they receive
Carpal tunnel releaseExperimentalOpen carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Receives: Procedure: Carpal tunnel release
Placebo surgeryPlacebo comparatorPlacebo surgery: Skin incision and division of palmar aponeurosis
Receives: Procedure: Placebo surgery
Observational armOtherOpen carpal tunnel release: skin incision, division of the palmar aponeurosis, and division of the transverse carpal ligament. Observational group: eligible participants included to assess potential selection bias.
Receives: Procedure: Carpal tunnel release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient acceptable symptom state (PASS)

    PASS is used as a binary global outcome using the following question:

    "Regarding your recovery from the carpal tunnel release, specifically pertaining to paresthesia, pain and overall function of the hand, would you be content if the clinical state of your hand would remain the same as it has been the past week?" Response options are: Yes, I would be content or No, I would not be content.

    Measured: 4 months

Secondary outcomes (8)

  1. Patient acceptable symptom state (PASS)

    PASS is used as a binary global outcome measure and will be assessed using the following question:

    "Regarding your recovery from the carpal tunnel release, specifically pertaining to paresthesia, pain and overall function of the hand, would you be content if the clinical state of your hand would remain the same as it has been the past week?" Response options are: Yes, I would be content or No, I would not be content.

    Measured: 6 and 9 months and 1,2,3,4 and 5 years

  2. Global Impression of Improvement (PGI-I)

    A single-item patient-reported measure indicating overall perceived improvement since the start of treatment, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse).

    Measured: 4, 6 and 9 months and 1,2,3,4 and 5 years

  3. 6-Item carpal tunnel syndrome (CTS) symptoms scale

    The CTS-6 is a validated six-item patient-reported questionnaire used to assess the severity of carpal tunnel syndrome symptoms, including pain, numbness or tingling, and functional impairment, with scores ranging from 0 (least severe) and 26 (most severe). A score >12 correlates with an 80% probability of CTS.

    Measured: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

  4. Patient-Specific Functional Scale (PSFS)

    The Patient-Specific Functional Scale (PSFS) is a patient-reported measure that assesses level of functional limitations in 3-5 activities identified as important by the patient and deemed difficult to perform by the patient, due to the hand condition. The PSFS is rated on an ordinal scale from 0 (unable to perform the activity) to 10 (able to perform the activity at the same level as before the disease.)

    Measured: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

  5. Numeric Pain Rating Scale (NRS)

    A patient-reported measure for pain intensity on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain).

    Measured: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

  6. Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value)

    EQ-5D-5L questionnaire, Finnish language version, using the Danish value set. Score ranges from values below 0 (health states considered worse than death) to 1.00 (full health), where higher scores indicate better health-related quality of life.

    Measured: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

  7. Health-related quality of life: EuroQol 5-Dimensions (EQ-5D) Visual Analogue Scale (VAS) (EQ VAS) )

    EQ-5D is a generic patient rated outcome measure (PROM) comprising five health dimensions (mobility, self-care, daily activities, pain/discomfort, anxiety/depression) and a VAS. EQVAS is a vertical visual analogue scale, on which patients rate their general health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

  8. Harms

    Harms and healthcare contacts related to the operated hand will be collected systematically and unprompted using a standardized electronic case report files (eCRF). Events will be classified by type (Adverse event, Serious Adverse Event, Suspected Unexpected Serious Adverse Reaction), attribution, timing, and nature.

    Measured: Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start11 Jun 2026
  3. Primary completion30 May 2029 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

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
Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614425
Sponsor's protocol ID
HUS/683/2025
Acronym
FINCATS
Status last verified
Sep 2026
First submitted
21 May 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD provided that current legislation permits it.

Questions about this trial

What is this clinical trial studying?

A study testing Carpal tunnel release in people with Carpal Tunnel Syndrome, run by Helsinki University Central Hospital at 2 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 Susanna Stjernberg-Salmela, MD, PhD (0504274955 ext. +358, Susanna.Stjernberg-Salmela@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient acceptable symptom state (PASS) (time frame: 4 months). 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 NCT07614425.

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 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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