Finnish Carpal Tunnel Surgery Study
ConditionCarpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHelsinki University Central Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Carpal tunnel release
Procedure/SurgeryOpen carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Placebo surgery
Procedure/SurgerySkin incision and division of the palmar aponeurosis
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Carpal tunnel releaseExperimental treatment 1 intervention
Group B: Placebo surgeryPlacebo comparator 1 intervention
Group C: Observational armOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
4 monthsSecondary outcomes
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.
Time frame
6 and 9 months and 1,2,3,4 and 5 years2
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).
Time frame
4, 6 and 9 months and 1,2,3,4 and 5 years3
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.
Time frame
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years4
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.)
Time frame
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 yearsOther outcomes
1
Pillar pain - interview
Pillar pain will be assessed using two questions: 1. Do you have pain at rest in the palm of your hand? 2. Are you able to bear weight on your extended wrist and hand? Response options: Yes or No.
Time frame
At recruitment and 1 and 4 months after intervention.2
Pillar pain - pressure pain thresholds
Pillar pain will be assessed through pressure pain thresholds on thenar and hypothenar eminences with a digital algometer
Time frame
At recruitment and 1 and 4 months after intervention.3
Pillar pain - palmar skin sensation
Palmar skin sensation will be assessed at thenar and hypothenar eminences with a standard evaluation tool neuropen.
Time frame
At recruitment and 1 and 4 months after intervention.4
Blinding fidelity
Blinding fidelity will be assessed by asking participants which treatment group they believe they were allocated to. Response options will include "Carpal tunnel release," "Placebo intervention," or "Unsure."
Time frame
At 4 months after intervention.Sponsors and contacts
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Source ClinicalTrials.gov