손목 터널 증후군에 대한 야간 및 전일 부목의 효과 (FINCROSS)
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
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Vieda Lusa
- 전화번호: +358408713465
- 이메일: fincross.trial@gmail.com
연구 장소
-
-
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Helsinki, 핀란드
- 모병
- Terveystalo Kamppi
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연락하다:
- Teemu Paatela
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Jyväskylä, 핀란드
- 모병
- Hospital Nova of Central Finland
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연락하다:
- Teemu Karjalainen
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Jyväskylä, 핀란드
- 모병
- Terveystalo Jyväskylä
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연락하다:
- Teemu Karjalainen
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Mikkeli, 핀란드
- 모병
- Mikkeli Central Hospital
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연락하다:
- Anniina Laurema
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Tampere, 핀란드
- 모집하지 않고 적극적으로
- Tampere University Hospital
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Tampere, 핀란드
- 모병
- Terveystalo Tampere
-
연락하다:
- Teemu Karjalainen
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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),
- Symptom duration of CTS for at least 3 weeks,
- No previous corticosteroid injection for CTS during last 6 months,
- No previous surgery for CTS,
- Aged 18 years or older,
- Able to complete self-report questionnaires electronically,
- Able to understand Finnish,
- Willing to join the study and follow the study protocol instructions,
- Sign informed consent.
Exclusion Criteria:
- Nerve root or plexus disorders that might be causing CTS mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders),
- Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,
- Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,
- Thenar muscle atrophy,
- Untreated hypothyroidism,
- Known allergy to any of the splint materials (self-reported by patient),
- Long term treatment (over 4 months) for CTS with no response,
- Any other known reason that could prevent from participation for the study time.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 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. |
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. |
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. |
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. |
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. |
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. |
neutral-positioned wrist orthosis |
연구는 무엇을 측정합니까?
주요 결과 측정
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
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
협력자
협력자
수사관
수사관
- 수석 연구원: Teemu Karjalainen, Tampere University Hospital
- 수석 연구원: Jarkko Jokihaara, Tampere University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- R22093
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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