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

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.

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.).

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: splinting

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vieda Lusa; Phone Number: +358408713465; Email: fincross.trial@gmail.com

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Terveystalo Kamppi
    • Contact: Teemu Paatela
  • Jyväskylä, Finland
    • Recruiting
    • Terveystalo Jyvaskyla
    • Contact: Teemu Karjalainen
  • Jyväskylä, Finland
    • Recruiting
    • Hospital Nova of Central Finland
    • Contact: Teemu Karjalainen
  • Mikkeli, Finland
    • Recruiting
    • Mikkeli Central Hospital
    • Contact: Anniina Laurema
  • Tampere, Finland
    • Active, not recruiting
    • Tampere University Hospital
  • Tampere, Finland
    • Recruiting
    • Terveystalo Tampere
    • Contact: Teemu Karjalainen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: splinting; neutral-positioned wrist orthosis
Other: 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.	Device: splinting; neutral-positioned wrist orthosis
Other: 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.	Device: splinting; neutral-positioned wrist orthosis
Other: 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.	Device: splinting; neutral-positioned wrist orthosis
Other: 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.	Device: splinting; neutral-positioned wrist orthosis
Other: 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.	Device: splinting; neutral-positioned wrist orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Mikkeli Central Hospital; Terveystalo; Hospital Nova of Central Finland
• Investigators: Principal Investigator: Teemu Karjalainen, Tampere University Hospital; Principal Investigator: Jarkko Jokihaara, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; splinting; no-treatment; cross-over trial
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: R22093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No