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

Carpal Tunnel Syndrome Clinical Trial

— FINCROSS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637294
• Other study ID #: R22093
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Tampere University Hospital
• Contact: Vieda Lusa
• Phone: +358408713465
• Email: fincross.trial[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• splinting
neutral-positioned wrist orthosis

Locations

Country	Name	City	State
Finland	Terveystalo Kamppi	Helsinki
Finland	Hospital Nova of Central Finland	Jyväskylä
Finland	Terveystalo Jyväskylä	Jyväskylä
Finland	Tampere University Hospital	Tampere
Finland	Terveystalo Tampere	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Hospital Nova of Central Finland, Terveystalo

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse effects	Assessed by participant self-reported adverse events.	up to 1 year
Secondary	Need for surgery	Assessed by participant self-reported information of referral to or executed surgery.	up to 1 year
Secondary	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