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Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction (MT-CTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01949493
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : December 9, 2016
Information provided by (Responsible Party):
prof.dr. Victor J Pop, University of Tilburg

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: mechanical traction Other: Care as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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. ]
    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.

  2. Change from baseline in absenteeism from work [ Time Frame: 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.

  3. Change from baseline in health care related resource utilization [ Time Frame: 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.

Other Outcome Measures:
  1. 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. ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01949493

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Viecuri Medisch Centrum
Venlo, Limburg, Netherlands, 5912 BL
Sponsors and Collaborators
University of Tilburg
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Principal Investigator: Victor Pop, Prof. Dr. University of Tilburg
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Responsible Party: prof.dr. Victor J Pop, Prof. Dr. V.J.M. Pop, University of Tilburg Identifier: NCT01949493    
Other Study ID Numbers: NL44692.008.13
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by prof.dr. Victor J Pop, University of Tilburg:
carpal tunnel syndrome
mechanical traction
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries