Overview

This trial is active, not recruiting.

Condition carpal tunnel syndrome
Treatments mechanical traction, care as usual
Sponsor University of Tilburg
Start date October 2013
End date June 2016
Trial size 200 participants
Trial identifier NCT01949493, NL44692.008.13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
care as usual
Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
(Experimental)
Twelve treatments with mechanical traction using the Phystrac traction apparatus.
mechanical traction Phystrac mechanical traction device (type GR 10)
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.
Change from baseline in absenteeism from work
time frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Change from baseline in health care related resource utilization
time frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Victor Pop, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Tilburg.