Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction

Carpal Tunnel Syndrome Clinical Trial

— MT-CTS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949493
• Other study ID #: NL44692.008.13
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: December 8, 2016
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: University of Tilburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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:
• Care as usual
Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).

Locations

Country	Name	City	State
Netherlands	Viecuri Medisch Centrum	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Tilburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No