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

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

The objective of this study is to evaluate the effectiveness of mechanical traction in patients with Carpal Tunnel Syndrome compared to care as usual.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Care as usual; Device: mechanical traction

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Venlo, Limburg, Netherlands, 5912 BL
      • VieCuri Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Phystrac mechanical traction device (type GR 10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in symptom severity and functional status on the Boston Carpal Tunnel Questionnaire (BCTQ) at 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.	Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in quality of life on abbreviated version of the World Health Organisation Quality of Life (WHOQOL-BREF)	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.	Baseline, 6 weeks (intervention group) and 3, 6 and 12 months.
Change from baseline in absenteeism from work	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.	Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Change from baseline in health care related resource utilization	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.	Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in depression and anxiety on the 4-item Patient Health Questionnaire (PHQ-4)	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.	Baseline, 6 weeks (intervention groups and 3, 6, and 12 months.

Collaborators and Investigators

• Sponsor: Tilburg University
• Investigators: Principal Investigator: Victor Pop, Prof. Dr., Tilburg University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; traction; mechanical traction; Phystrac
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: NL44692.008.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No