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| Name | Class |
|---|---|
| Terveystalo | OTHER |
| Hospital Nova, Central Finland | OTHER |
| Mikkeli Central Hospital | OTHER |
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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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence of three treatment periods in the following order: ABC | Other | 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. |
|
| Sequence of three treatment periods in the following order: ACB | Other | 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. |
|
| Sequence of three treatment periods in the following order: BAC | Other | 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. |
|
| Sequence of three treatment periods in the following order: BCA | Other | 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. |
|
| Sequence of three treatment periods in the following order: CAB |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| splinting | Device | neutral-positioned wrist orthosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vieda Lusa | Contact | +358408713465 | fincross.trial@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Teemu Karjalainen | Tampere University Hospital | Principal Investigator |
| Jarkko Jokihaara | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terveystalo Kamppi | Recruiting | Helsinki | Finland |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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Multicentre, three-treatment, three-period, randomised, crossover superiority trial (3 x 6 crossover design)
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| Other |
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. |
|
| Sequence of three interventions/treatments in the following order: CBA | Other | 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. |
|
| Change of The 6-item CTS Symptoms Scale scores between baseline and 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Finnish version of EQ-5D-5L will be used. | 1 year |
| Adverse effects | Assessed by participant self-reported adverse events. | up to 1 year |
| Need for surgery | 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) | Assessed by participant self-reported information of undergoing or having undergone the escape treatment. | up to 1 year |
| Hospital Nova of Central Finland | Recruiting | Jyväskylä | Finland |
|
| Terveystalo Jyväskylä | Recruiting | Jyväskylä | Finland |
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| Mikkeli Central Hospital | Recruiting | Mikkeli | Finland |
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| Tampere University Hospital | Active, not recruiting | Tampere | Finland |
| Terveystalo Tampere | Recruiting | Tampere | Finland |
|
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |