Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction
NCT ID: NCT01949493
Last Updated: 2016-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
181 participants
INTERVENTIONAL
2013-10-31
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Care as usual
Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
Mechanical traction
Twelve treatments with mechanical traction using the Phystrac traction apparatus.
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.
Interventions
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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.
Care as usual
Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* other known (rare) cause of neuropathy
* suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder
18 Years
80 Years
ALL
No
Sponsors
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Tilburg University
OTHER
Responsible Party
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prof.dr. Victor J Pop
Prof. Dr. V.J.M. Pop
Principal Investigators
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Victor Pop, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Tilburg University
Locations
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Viecuri Medisch Centrum
Venlo, Limburg, Netherlands
Countries
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References
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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.
Other Identifiers
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NL44692.008.13
Identifier Type: -
Identifier Source: org_study_id