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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Tilburg
Sponsor:
Information provided by (Responsible Party):
prof.dr. Victor J Pop, University of Tilburg
ClinicalTrials.gov Identifier:
NCT01949493
First received: September 19, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention
Carpal Tunnel Syndrome
Device: mechanical traction
Other: Care as usual

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Tilburg:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed CTS with positive electromyogram (EMG)
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949493

Contacts
Contact: Margreet Meems, Msc 0031621965245 maggiemeems@hotmail.com
Contact: Victor Pop, Prof. Dr. 0031655751614 v.j.m.pop@uvt.nl

Locations
Netherlands
Viecuri Medisch Centrum Recruiting
Venlo, Limburg, Netherlands, 5912 BL
Contact: Margreet Meems, Msc    0031621965245    maggiemeems@hotmail.com   
Sub-Investigator: Margreet Meems, Msc         
Sponsors and Collaborators
University of Tilburg
Investigators
Principal Investigator: Victor Pop, Prof. Dr. University of Tilburg
  More Information

No publications provided

Responsible Party: prof.dr. Victor J Pop, Prof. Dr. V.J.M. Pop, University of Tilburg
ClinicalTrials.gov Identifier: NCT01949493     History of Changes
Other Study ID Numbers: NL44692.008.13
Study First Received: September 19, 2013
Last Updated: February 13, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University of Tilburg:
carpal tunnel syndrome
traction
mechanical traction
Phystrac

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014