Carpal Tunnel SyndromeFINCROSSNCT05637294
Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome
A study testing splinting in people with Carpal Tunnel Syndrome, run by Tampere University Hospital at 6 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- splinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesFinland
- Study dates
- 15 Feb 2023to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- Able to understand Finnish,
- Willing to join the study and follow the study protocol instructions,
- Sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Finland6 sites, 5 recruiting
- Recruiting
Terveystalo Kamppi
Helsinki
Teemu Paatela
- Recruiting
Hospital Nova of Central Finland
Jyväskylä
Teemu Karjalainen
- Recruiting
Terveystalo Jyväskylä
Jyväskylä
Teemu Karjalainen
- Recruiting
Mikkeli Central Hospital
Mikkeli
Anniina Laurema
- Active, not recruiting
Tampere University Hospital
Tampere
- Recruiting
Terveystalo Tampere
Tampere
Teemu Karjalainen
About this study
Official title: Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome: a Multi-center, Three-period, Randomized Cross-over Superiority Trial (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.
Read more
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.).
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- splinting
- Keywords
- carpal tunnel syndrome, splinting, no-treatment, cross-over trial
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splintingDevice
neutral-positioned wrist orthosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: splinting |
| 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. Receives: Device: splinting |
| 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. Receives: Device: splinting |
| 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. Receives: Device: splinting |
| Sequence of three treatment periods in the following order: CAB | 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. Receives: Device: splinting |
| 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. Receives: Device: splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks, i.e. end of each treatment period
Secondary outcomes (15)
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.
Measured: 3 weeks, i.e. middle of each treatment 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Adverse effects
Assessed by participant self-reported adverse events.
Measured: up to 1 year
Need for surgery
Assessed by participant self-reported information of referral to or executed surgery.
Measured: 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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Feb 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicentre, three-treatment, three-period, randomised, crossover superiority trial (3 x 6 crossover design)
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Terveystalo, Hospital Nova, Central Finland, Mikkeli Central Hospital
- Responsible party
- Sponsor
- Investigators
- Teemu Karjalainen, Principal investigator, Tampere University HospitalJarkko Jokihaara, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637294
- Sponsor's protocol ID
- R22093
- Acronym
- FINCROSS
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No