Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Care as usual; Device: mechanical traction

• Registration Number: NCT01949493
• Lead Sponsor: Tilburg University

Brief Summary

The objective of this study is to evaluate the effectiveness of mechanical traction in patients with Carpal Tunnel Syndrome compared to care as usual.

Detailed Description

This randomized controlled trial will examine the effectiveness of mechanical traction compared to care as usual as a non-surgical treatment for Carpal Tunnel Syndrome (CTS).

Patients diagnosed with CTS are recruited from the outpatient neurology clinic of VieCuri Medical Center in Venlo, The Netherlands. They will be randomly assigned to the intervention or control group. Patients in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. Patients in the control group will receive care as usual, which can include splinting, a corticosteroid injection, carpal tunnel release surgery or an expectant strategy. Outcomes will be assessed at baseline and at 3, 6, and 12 months after inclusion.

Study Timeline

• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Study Start: 2013-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• diagnosed with CTS using electrodiagnostic testing
• being physically capable of visiting the outpatient clinic in Venlo twice per week
• being physically capable of sitting in upright position in a chair for 10-20 minutes, twice per week
• not intending to move outside the area within 3 months after inclusion

Exclusion Criteria

• not understanding Dutch appropriately
• other known (rare) cause of neuropathy
• suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care as usual	Care as usual	The patient will receive the usual care provided by the neurologists at VieCuri Medical Center. This may include an expectant strategy, a wrist splint, corticosteroid injection or carpal tunnel release surgery.
Mechanical traction	mechanical traction	Twelve treatments with mechanical traction using the Phystrac traction apparatus.

Primary Outcome Measures

Name	Time	Method
Change from baseline in symptom severity and functional status on the Boston Carpal Tunnel Questionnaire (BCTQ) at 12 months	Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.	Functional status and symptom severity will be measured using a self-reported scale: the BCTQ. The BCTQ is a disease-specific questionnaire and consists of two different scales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 questions about symptom severity. The FSS consists of 8 daily activities which are rated based on degree of difficulty. The SSS and the FSS are rated on a five-point scale, where a higher score represents a greater impairment.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in quality of life on abbreviated version of the World Health Organisation Quality of Life (WHOQOL-BREF)	Baseline, 6 weeks (intervention group) and 3, 6 and 12 months.	Self-reported quality of life will be measured using the WHOQOL-BREF in Dutch. It consists of 26 items which can be scored on a five-point scale. Better quality of life is represented by a higher score.
Change from baseline in absenteeism from work	Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.	A non-standardized questionnaire is used to collect the number of days off work of each patient. Patients are also asked if they are currently on sick leave or have been because of their CTS complaints.
Change from baseline in health care related resource utilization	Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.	A non-standardized questionnaire is used to assess if patients have visited a professional caregiver (general practitioner, physiotherapist, psychologist, etc.) in the past 12 months, if they spent time in the hospital or use medication.

Trial Locations

Locations (1)

Viecuri Medisch Centrum; 🇳🇱 Venlo, Limburg, Netherlands