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

NCT05637294 | Recruiting

• 1 other identifier: R22093
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

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.).

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; splinting; no-treatment; cross-over trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks

  3 weeks, i.e. middle of each treatment period

• Change of The 6-item CTS Symptoms Scale scores between baseline and 1 year

  1 year

• 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

• Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 1 year

  1 year

• 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

Study Arms (6)

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.

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.

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.

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.

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.

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.

Device: splinting

Interventions

splinting DEVICE

neutral-positioned wrist orthosis

Sequence of three interventions/treatments in the following order: CBA; Sequence of three treatment periods in the following order: ABC; Sequence of three treatment periods in the following order: ACB; Sequence of three treatment periods in the following order: BAC; Sequence of three treatment periods in the following order: BCA; Sequence of three treatment periods in the following order: CAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Terveystalo: collaborator
• Hospital Nova of Central Finland: collaborator
• Mikkeli Central Hospital: collaborator

Study Sites (6)

Terveystalo Kamppi

Helsinki, Finland

RECRUITING

Hospital Nova of Central Finland

Jyväskylä, Finland

RECRUITING

Terveystalo Jyväskylä

Jyväskylä, Finland

RECRUITING

Mikkeli Central Hospital

Mikkeli, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

ACTIVE NOT RECRUITING

Terveystalo Tampere

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Teemu Karjalainen

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Jarkko Jokihaara

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vieda Lusa

CONTACT

+358408713465; fincross.trial@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, three-treatment, three-period, randomised, crossover superiority trial (3 x 6 crossover design)

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: December 5, 2022
• Study Start: February 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (6)