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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Susanna Stjernberg-Salmela, MD, PhD
- 電話番号：+358 0504274955
- メール：Susanna.Stjernberg-Salmela@hus.fi
研究連絡先のバックアップ
- 名前：Kati MJ Jaatinen
- メール：kati.jaatinen@hus.fi
研究場所
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Helsinki、フィンランド
- 募集
- HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
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コンタクト：
- Saara Raatikainen
- メール：Saara.Raatikainen@hus.fi
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コンタクト：
- Susanna Stjernberg-Salmela, MD
- 電話番号：+358 0504274955
- メール：Susanna.Stjernberg-Salmela@hus.fi
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Tampere、フィンランド
- まだ募集していません
- Wellbeing Services County of Pirkamaa, Tampere Central University Hospital
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コンタクト：
- Jarkko Jokihaara
- メール：Jarkko.Jokihaara@tuni.fi
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コンタクト：
- Teemu Karjalainen
- メール：Teemu.Karjalainen@pirha.fi
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient acceptable symptom state (PASS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient acceptable symptom state (PASS)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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) )
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pillar pain - interview
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Teppo LN Järvinen, Professor、Helsinki University Central Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HUS/683/2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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