Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: splinting

• Registration Number: NCT05637294
• Lead Sponsor: Tampere University Hospital

Brief 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.

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.).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Study Start: 2023-02-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 or surgery during last 6 months,
4. Aged 18 years or older,
5. Able to complete self-report questionnaires electronically,
6. Able to understand Finnish,
7. Willing to join the study and follow the study protocol instructions,
8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence of three treatment periods in the following order: BAC	splinting	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: ACB	splinting	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: BCA	splinting	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: ABC	splinting	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: CAB	splinting	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	splinting	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.

Primary Outcome Measures

Name	Time	Method
Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks	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.
Change of The 6-item CTS Symptoms Scale scores between baseline and 1 year	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.
Overall improvement as measured by 7-point Likert Scale	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.
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 1 year	1 year	Finnish version of EQ-5D-5L will be used.
Escape treatments (e.g., corticosteroid injection or any other treatment supervised by medical personnel)	up to 1 year	Assessed by participant self-reported information of undergoing or having undergone the escape treatment.
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 6 weeks of each treatment period	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.
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 6 weeks of each treatment period	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.
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 6 weeks	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.
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	6 weeks, i.e. end of each treatment period	Finnish version of EQ-5D-5L will be used.
Need for surgery	up to 1 year	Assessed by participant self-reported information of referral to or executed surgery.
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 1 year	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.
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 1 year	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.
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 1 year	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.
Adverse effects	up to 1 year	Assessed by participant self-reported adverse events.

Trial Locations

Locations (6)

Terveystalo Kamppi; 🇫🇮 Helsinki, Finland

Hospital Nova of Central Finland; 🇫🇮 Jyväskylä, Finland

Terveystalo Jyväskylä; 🇫🇮 Jyväskylä, Finland

Mikkeli Central Hospital; 🇫🇮 Mikkeli, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Terveystalo Tampere; 🇫🇮 Tampere, Finland