Clinical trial NCT01949493: Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
traction
mechanical traction
Phystrac
Lead sponsor: Tilburg University
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in symptom severity and functional status on the Boston Carpal Tunnel Questionnaire (BCTQ) at 12 months
timeFrame: 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)
timeFrame: Baseline, 6 weeks (intervention group) and 3, 6 and 12 months.
measure: Change from baseline in absenteeism from work
timeFrame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
measure: Change from baseline in health care related resource utilization
timeFrame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Other outcomes:
measure: Change from baseline in depression and anxiety on the 4-item Patient Health Questionnaire (PHQ-4)
timeFrame: Baseline, 6 weeks (intervention groups and 3, 6, and 12 months.
Locations:
city: Venlo
country: Netherlands
facility: Viecuri Medisch Centrum
state: Limburg
Study officials:
affiliation: Tilburg University
name: Victor Pop, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meems M, Boekhorst MGBM, Pop VJM. Long-Term Follow-Up Results of Mechanical Wrist Traction as Non-Invasive Treatment for Carpal Tunnel Syndrome. Front Neurol. 2021 Sep 6;12:668549. doi: 10.3389/fneur.2021.668549. eCollection 2021.