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손목 터널 증후군에 대한 야간 및 전일 부목의 효과 (FINCROSS)

2026년 9월 29일 업데이트: Tampere University Hospital

수근관 증후군에 대한 야간 및 전일제 부목의 효과: 다기관, 3주기, 무작위 교차 우월성 시험(FINCROSS - Finnish Crossover Trial for Carpal Tunnel Syndrome)

Carpal tunnel syndrome is a common compression neuropathy of upper extremities. Its usual symptoms are pain, numbness and tingling of fingers, which tend to be worse at night. Splinting the wrist with an external orthosis is usually a first-line treatment provided to most people with mild to moderate disease.

The FINCROSS trial (randomized cross-over trial) aims to assess the effect of night-time and full-time splinting in comparison with no-treatment. It also aims to identify possible subgroups of people who would benefit from splinting, as well as assess if positive response to splinting is associated with subsequent lower need of surgery.

The trial will recruit 110 people with carpal tunnel syndrome in Finland. Each participant will undergo all three treatment periods in a randomised order: 1) splinting at night-time for six weeks, 2) splinting both day and night for six weeks; and 3) be assessed under a six weeks long control period of no-treatment.

Each treatment period will be separated with a three-week washout period. Therefore, the whole treatment sequence for each participant lasts 24 weeks after randomization. The participant will be followed-up to 1 year after the randomisation.

Additionally, the participants will get instructions for self-administered stretching exercises to perform throughout the study. All participants will be asked to avoid any intervention administered or supervised by medical personnel (such as structured supervised exercises, manual therapy, steroid injections, surgery, etc.).

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

110

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 핀란드
      • Helsinki, 핀란드
        • 모병
        • Terveystalo Kamppi
        • 연락하다:
          • Teemu Paatela
      • Jyväskylä, 핀란드
        • 모병
        • Hospital Nova of Central Finland
        • 연락하다:
          • Teemu Karjalainen
      • Jyväskylä, 핀란드
        • 모병
        • Terveystalo Jyväskylä
        • 연락하다:
          • Teemu Karjalainen
      • Mikkeli, 핀란드
        • 모병
        • Mikkeli Central Hospital
        • 연락하다:
          • Anniina Laurema
      • Tampere, 핀란드
        • 모집하지 않고 적극적으로
        • Tampere University Hospital
      • Tampere, 핀란드
        • 모병
        • Terveystalo Tampere
        • 연락하다:
          • Teemu Karjalainen

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Clinically confirmed carpal tunnel syndrome (CTS) of any severity level (diagnostic criteria: numbness, pain or paraesthesia in the median nerve distribution area of wrist and fingers),
  2. Symptom duration of CTS for at least 3 weeks,
  3. No previous corticosteroid injection for CTS during last 6 months,
  4. No previous surgery for CTS,
  5. Aged 18 years or older,
  6. Able to complete self-report questionnaires electronically,
  7. Able to understand Finnish,
  8. Willing to join the study and follow the study protocol instructions,
  9. Sign informed consent.

Exclusion Criteria:

  1. Nerve root or plexus disorders that might be causing CTS mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders),
  2. Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,
  3. Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,
  4. Thenar muscle atrophy,
  5. Untreated hypothyroidism,
  6. Known allergy to any of the splint materials (self-reported by patient),
  7. Long term treatment (over 4 months) for CTS with no response,
  8. Any other known reason that could prevent from participation for the study time.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Sequence of three treatment periods in the following order: ABC

Splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
장치: splinting

neutral-positioned wrist orthosis
다른: Sequence of three treatment periods in the following order: ACB

Splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
장치: splinting

neutral-positioned wrist orthosis
다른: Sequence of three treatment periods in the following order: BAC

No treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
장치: splinting

neutral-positioned wrist orthosis
다른: Sequence of three treatment periods in the following order: BCA

No treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
장치: splinting

neutral-positioned wrist orthosis
다른: Sequence of three treatment periods in the following order: CAB

Splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
장치: splinting

neutral-positioned wrist orthosis
다른: Sequence of three interventions/treatments in the following order: CBA

Splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
장치: splinting

neutral-positioned wrist orthosis

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks
기간: 6 weeks, i.e. end of each treatment period

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
6 weeks, i.e. end of each treatment period

2차 결과 측정

결과 측정
측정값 설명
기간
Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks
기간: 3 weeks, i.e. middle of each treatment period

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
3 weeks, i.e. middle of each treatment period
Change of The 6-item CTS Symptoms Scale scores between baseline and 1 year
기간: 1 year

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
1 year
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 6 weeks of each treatment period
기간: 6 weeks, i.e. end of each treatment period

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 1 year
기간: 1 year

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.
1 year
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 6 weeks of each treatment period
기간: 6 weeks, i.e. end of each treatment period

BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 1 year
기간: 1 year

BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.
1 year
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 6 weeks
기간: 6 weeks, i.e. end of each treatment period

BCTQ Total consists of BCTQ SSS and BCTQ FSS, with score from 1 to 5 to each of the item, higher score indicating worse function.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 1 year
기간: 1 year

BCTQ Total consists of BCTQ SSS and BCTQ FSS, with score from 1 to 5 to each of the item, higher score indicating worse function.
1 year
Overall improvement as measured by 7-point Likert Scale
기간: 6 weeks, i.e. end of each treatment period

7-point Likert Scale assesses the improvement of hand symptoms with 7 possible scores: much better, better, somewhat better, no changes, somewhat worse, worse, much worse.
6 weeks, i.e. end of each treatment period
Overall improvement as measured by 7-point Likert Scale
기간: 1 year

7-point Likert Scale assesses the improvement of hand symptoms with 7 possible scores: much better, better, somewhat better, no changes, somewhat worse, worse, much worse.
1 year
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 6 weeks of each treatment period
기간: 6 weeks, i.e. end of each treatment period

Finnish version of EQ-5D-5L will be used.
6 weeks, i.e. end of each treatment period
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 1 year
기간: 1 year

Finnish version of EQ-5D-5L will be used.
1 year
Adverse effects
기간: up to 1 year

Assessed by participant self-reported adverse events.
up to 1 year
Need for surgery
기간: up to 1 year

Assessed by participant self-reported information of referral to or executed surgery.
up to 1 year
Escape treatments (e.g., corticosteroid injection or any other treatment supervised by medical personnel)
기간: up to 1 year

Assessed by participant self-reported information of undergoing or having undergone the escape treatment.
up to 1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tampere University Hospital

협력자

Mikkeli Central Hospital
Terveystalo
Hospital Nova, Central Finland

수사관

  • 수석 연구원: Teemu Karjalainen, Tampere University Hospital
  • 수석 연구원: Jarkko Jokihaara, Tampere University Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 2월 15일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2022년 10월 18일

QC 기준을 충족하는 최초 제출

2022년 11월 23일

처음 게시됨 (실제)

2022년 12월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R22093

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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