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NCT Number: NCT05637294

Effect of Night-time and Full-time Splinting 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.).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Terveystalo Kamppi, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Splinting

Device

neutral-positioned wrist orthosis

Primary outcomes

  1. Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 6 weeks of each treatment period

    Time frame: 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.

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

    Time frame: 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.

  5. Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 6 weeks of each treatment period

    Time frame: 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.

  6. Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 1 year

    Time frame: 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.

  7. Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 6 weeks

    Time frame: 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.

  8. Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 1 year

    Time frame: 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.

  9. Overall improvement as measured by 7-point Likert Scale

    Time frame: 6 weeks, i.e. end of each treatment period

    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.

  10. Overall improvement as measured by 7-point Likert Scale

    Time frame: 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.

  11. 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

    Time frame: 6 weeks, i.e. end of each treatment period

    Finnish version of EQ-5D-5L will be used.

  12. Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 1 year

    Time frame: 1 year

    Finnish version of EQ-5D-5L will be used.

  13. Adverse effects

    Time frame: up to 1 year

    Assessed by participant self-reported adverse events.

  14. Need for surgery

    Time frame: up to 1 year

    Assessed by participant self-reported information of referral to or executed surgery.

  15. Escape treatments (e.g., corticosteroid injection or any other treatment supervised by medical personnel)

    Time frame: up to 1 year

    Assessed by participant self-reported information of undergoing or having undergone the escape treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Vieda Lusa

CONTACT

[email protected]

+358408713465

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Hospital Nova, Central Finland
  • Mikkeli Central Hospital
  • Terveystalo

Registry information

Official study 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)

Acronym: FINCROSS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2022
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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