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

NCT01949493 | Completed

• 1 other identifier: NL44692.008.13
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; traction; mechanical traction; Phystrac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in quality of life on abbreviated version of the World Health Organisation Quality of Life (WHOQOL-BREF)

  Baseline, 6 weeks (intervention group) and 3, 6 and 12 months.

• Change from baseline in absenteeism from work

  Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.

• Change from baseline in health care related resource utilization

  Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.

Other Outcomes (1)

• Change from baseline in depression and anxiety on the 4-item Patient Health Questionnaire (PHQ-4)

  Baseline, 6 weeks (intervention groups and 3, 6, and 12 months.

Study Arms (2)

Care as usual

OTHER

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

Mechanical traction

EXPERIMENTAL

Twelve treatments with mechanical traction using the Phystrac traction apparatus.

Device: mechanical traction

Interventions

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.

Also known as: Phystrac mechanical traction device (type GR 10)

Mechanical traction

Care as usual OTHER

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

Care as usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not understanding Dutch appropriately
• other known (rare) cause of neuropathy
• suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder

Sponsors & Collaborators

• Tilburg University: lead

Study Sites (1)

Viecuri Medisch Centrum

Venlo, Limburg, 5912 BL, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34552548 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Victor Pop, Prof. Dr.

  Tilburg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. V.J.M. Pop

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 9, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)