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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTampere University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Crossover

Treatments tested in this trial

  • splinting

    Device

    neutral-positioned wrist orthosis

Treatment groups

110 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Sequence of three treatment periods in the following order: ABCOther 1 intervention
Group B: Sequence of three treatment periods in the following order: ACBOther 1 intervention
Group C: Sequence of three treatment periods in the following order: BACOther 1 intervention
Group D: Sequence of three treatment periods in the following order: BCAOther 1 intervention
Group E: Sequence of three treatment periods in the following order: CABOther 1 intervention
Group F: Sequence of three interventions/treatments in the following order: CBAOther 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
3 weeks, i.e. middle of each treatment period
2

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.

Time frame
1 year
3

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.

Time frame
6 weeks, i.e. end of each treatment period
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University Hospital

Lead sponsor

Terveystalo

Collaborator

Hospital Nova, Central Finland

Collaborator

Mikkeli Central Hospital

Collaborator