Finnish Carpal Tunnel Surgery Study (FINCATS)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Susanna Stjernberg-Salmela, MD, PhD
- 전화번호: +358 0504274955
- 이메일: Susanna.Stjernberg-Salmela@hus.fi
연구 연락처 백업
- 이름: Kati MJ Jaatinen
- 이메일: kati.jaatinen@hus.fi
연구 장소
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Helsinki, 핀란드
- 모병
- HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
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연락하다:
- Saara Raatikainen
- 이메일: Saara.Raatikainen@hus.fi
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연락하다:
- Susanna Stjernberg-Salmela, MD
- 전화번호: +358 0504274955
- 이메일: Susanna.Stjernberg-Salmela@hus.fi
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Tampere, 핀란드
- 아직 모집하지 않음
- Wellbeing Services County of Pirkamaa, Tampere Central University Hospital
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연락하다:
- Jarkko Jokihaara
- 이메일: Jarkko.Jokihaara@tuni.fi
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연락하다:
- Teemu Karjalainen
- 이메일: Teemu.Karjalainen@pirha.fi
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
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Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
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위약 비교기: Placebo surgery
Placebo surgery: Skin incision and division of palmar aponeurosis
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Skin incision and division of the palmar aponeurosis
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다른: Observational arm
Open 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. |
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient acceptable symptom state (PASS)
기간: 4 months
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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. |
4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient acceptable symptom state (PASS)
기간: 6 and 9 months and 1,2,3,4 and 5 years
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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. |
6 and 9 months and 1,2,3,4 and 5 years
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Numeric Pain Rating Scale (NRS)
기간: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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A patient-reported measure for pain intensity on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain).
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At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value)
기간: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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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.
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At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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Harms
기간: Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant
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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.
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Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant
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Global Impression of Improvement (PGI-I)
기간: 4, 6 and 9 months and 1,2,3,4 and 5 years
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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).
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4, 6 and 9 months and 1,2,3,4 and 5 years
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6-Item carpal tunnel syndrome (CTS) symptoms scale
기간: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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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.
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At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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Patient-Specific Functional Scale (PSFS)
기간: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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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.)
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At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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Health-related quality of life: EuroQol 5-Dimensions (EQ-5D) Visual Analogue Scale (VAS) (EQ VAS) )
기간: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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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).
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At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pillar pain - interview
기간: At recruitment and 1 and 4 months after intervention.
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Pillar pain will be assessed using two questions:
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At recruitment and 1 and 4 months after intervention.
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Pillar pain - pressure pain thresholds
기간: At recruitment and 1 and 4 months after intervention.
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Pillar pain will be assessed through pressure pain thresholds on thenar and hypothenar eminences with a digital algometer
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At recruitment and 1 and 4 months after intervention.
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Pillar pain - palmar skin sensation
기간: At recruitment and 1 and 4 months after intervention.
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Palmar skin sensation will be assessed at thenar and hypothenar eminences with a standard evaluation tool neuropen.
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At recruitment and 1 and 4 months after intervention.
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Blinding fidelity
기간: At 4 months after intervention.
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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."
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At 4 months after intervention.
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Conduction velocity
기간: At 4 months after intervention.
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Nerve conduction velocities will be assessed in randomized participants using standard electroneurography techniques.
Measurements will quantify median nerve function across the carpal tunnel to evaluate changes after intervention.
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At 4 months after intervention.
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Medication
기간: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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Need for medication due to pain.
Response options: Every day, On most days of the week, 1-2 times a week, Rarely 5. Never
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At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
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Clinical examination
기간: At recruitment; at 4, and 12 months; and at 5 years after primary surgery.
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Standard hand surgical clinical examination and provocation tests: Tinell, Tethro, Phalen and atrophy evaluation
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At recruitment; at 4, and 12 months; and at 5 years after primary surgery.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Teppo LN Järvinen, Professor, Helsinki University Central Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HUS/683/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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