Clinical trial NCT05637294: Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
splinting
no-treatment
cross-over trial
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Terveystalo
name: Hospital Nova of Central Finland
name: Mikkeli Central Hospital
First posted: 2022-12-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicentre, three-treatment, three-period, randomised, crossover superiority trial (3 x 6 crossover design)
Primary purpose: TREATMENT

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.).


Eligibility 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.

Primary outcomes:
measure: Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks
timeFrame: 6 weeks, i.e. end of each treatment period
Secondary outcomes:
measure: Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks
timeFrame: 3 weeks, i.e. middle of each treatment period
measure: Change of The 6-item CTS Symptoms Scale scores between baseline and 1 year
timeFrame: 1 year
measure: Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 6 weeks of each treatment period
timeFrame: 6 weeks, i.e. end of each treatment period
measure: Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 1 year
timeFrame: 1 year
measure: Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 6 weeks of each treatment period
timeFrame: 6 weeks, i.e. end of each treatment period
measure: Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 1 year
timeFrame: 1 year
measure: Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 6 weeks
timeFrame: 6 weeks, i.e. end of each treatment period
measure: Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 1 year
timeFrame: 1 year
measure: Overall improvement as measured by 7-point Likert Scale
timeFrame: 6 weeks, i.e. end of each treatment period
measure: Overall improvement as measured by 7-point Likert Scale
timeFrame: 1 year
measure: 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
timeFrame: 6 weeks, i.e. end of each treatment period
measure: Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 1 year
timeFrame: 1 year
measure: Adverse effects
timeFrame: up to 1 year
measure: Need for surgery
timeFrame: up to 1 year
measure: Escape treatments (e.g., corticosteroid injection or any other treatment supervised by medical personnel)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Terveystalo Kamppi
city: Jyväskylä
country: Finland
facility: Hospital Nova of Central Finland
city: Jyväskylä
country: Finland
facility: Terveystalo Jyväskylä
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Tampere
country: Finland
facility: Terveystalo Tampere
Study officials:
affiliation: Tampere University Hospital
name: Teemu Karjalainen
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Jarkko Jokihaara
role: PRINCIPAL_INVESTIGATOR
References: