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Completed

NCT Number: NCT01949493

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Viecuri Medisch Centrum

Venlo, Limburg, 5912 BL, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical traction

Device

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)

Care as usual

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tilburg University

Other

Registry information

Official study 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

Acronym: MT-CTS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 24, 2013
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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