Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction (MT-CTS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of the Effectiveness of Mechanical Traction as a Non-Surgical Treatment for Carpal Tunnel Syndrome Compared to Care as Usual: a Randomized Controlled Trial|
- Change from baseline in symptom severity and functional status on the Boston Carpal Tunnel Questionnaire (BCTQ) at 12 months [ Time Frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months. ] [ Designated as safety issue: No ]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.
- Change from baseline in quality of life on abbreviated version of the World Health Organisation Quality of Life (WHOQOL-BREF) [ Time Frame: Baseline, 6 weeks (intervention group) and 3, 6 and 12 months. ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months. ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months. ] [ Designated as safety issue: No ]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.
- Change from baseline in depression and anxiety on the 4-item Patient Health Questionnaire (PHQ-4) [ Time Frame: Baseline, 6 weeks (intervention groups and 3, 6, and 12 months. ] [ Designated as safety issue: No ]Self-reported depression and anxiety is measured using the PHQ-4. The questionnaire consists of 2 items on depression and 2 on anxiety answered on a 4-point scale, where a higher score represents a higher level of anxiety and depression.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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.
Other: Care as usual
Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
Experimental: Mechanical traction
Twelve treatments with mechanical traction using the Phystrac traction apparatus.
Device: mechanical traction
Twelve treatments with mechanical traction using the Phystrac traction apparatus. The Phystrac provides traction to the wrist using weights between 1 and 18 kg. The weights provide a pulling force in line with the forearm. After 8 seconds the weight is lifted, and there is a rest period of 4 seconds. This cycle will be repeated 10 times. Another two sets of 10 traction movements will be applied with the wrist positioned in 30 degrees supination and 30 degrees pronation. In total, 30 traction movements will be applied during each treatment.
Other Name: Phystrac mechanical traction device (type GR 10)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949493
|Viecuri Medisch Centrum|
|Venlo, Limburg, Netherlands, 5912 BL|
|Principal Investigator:||Victor Pop, Prof. Dr.||University of Tilburg|