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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05637294
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : January 11, 2024
Sponsor:
Collaborators:
Terveystalo
Hospital Nova of Central Finland
Information provided by (Responsible Party):
Tampere University Hospital

Study Description
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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.).


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: splinting Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Multicentre, three-treatment, three-period, randomised, crossover superiority trial (3 x 6 crossover design)
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 15, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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
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
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
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
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637294


Contacts
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Contact: Vieda Lusa +358408713465 fincross.trial@gmail.com

Locations
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Finland
Terveystalo Kamppi Recruiting
Helsinki, Finland
Contact: Teemu Paatela         
Hospital Nova of Central Finland Recruiting
Jyväskylä, Finland
Contact: Lauri Karttunen         
Terveystalo Jyväskylä Recruiting
Jyväskylä, Finland
Contact: Teemu Karjalainen         
Tampere University Hospital Active, not recruiting
Tampere, Finland
Terveystalo Tampere Recruiting
Tampere, Finland
Contact: Teemu Karjalainen         
Sponsors and Collaborators
Tampere University Hospital
Terveystalo
Hospital Nova of Central Finland
Investigators
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Principal Investigator: Teemu Karjalainen Tampere University Hospital
Principal Investigator: Jarkko Jokihaara Tampere University Hospital
More Information
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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT05637294    
Other Study ID Numbers: R22093
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tampere University Hospital:
carpal tunnel syndrome
splinting
no-treatment
cross-over trial
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries