Carpal Tunnel Syndrome
Conditions
Keywords
Randomised controlled trial, Placebo-controlled trial, Surgery, Carpal tunnel syndrome, Carpal tunnel release
Brief 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 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.
Interventions
PROCEDURECarpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
PROCEDUREPlacebo surgery
Skin incision and division of the palmar aponeurosis
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, healthcare professionals other than the treating surgical team, outcome assessors, and investigators will be blinded to treatment allocation.
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient acceptable symptom state (PASS) | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient acceptable symptom state (PASS) | 6 and 9 months and 1,2,3,4 and 5 years | 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. |
| Global Impression of Improvement (PGI-I) | 4, 6 and 9 months and 1,2,3,4 and 5 years | 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). |
| 6-Item carpal tunnel syndrome (CTS) symptoms scale | At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years | 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. |
| Patient-Specific Functional Scale (PSFS) | At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years | 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.) |
| Numeric Pain Rating Scale (NRS) | At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years | A patient-reported measure for pain intensity on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). |
| Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value) | At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years | 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. |
| Health-related quality of life: EuroQol 5-Dimensions (EQ-5D) Visual Analogue Scale (VAS) (EQ VAS) ) | At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years | 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). |
| Harms | Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant | 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. |
Countries
Finland
Contacts
CONTACTSusanna Stjernberg-Salmela, MD, PhD
CONTACTKati MJ Jaatinen
STUDY_DIRECTORTeppo LN Järvinen, Professor
Helsinki University Central Hospital
Outcome results
None listed