The aim of this study is to investigate the effectiveness of the Phystrac in people with Carpal Tunnel Syndrome.The primary research question is:- Is there evidence that Phystrac might be an additional non-invasive option of treating CTS patients…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is:
- self-reported symptom severity and functional status
Secondary outcome
The secondary study parameters are:
- Quality of life
- absenteeism from work
- resource utilisation behaviour
Background summary
Carpal Tunnel Syndrome occurs in up to 5-8% of the general population and up to
11% of the working population. Apart from the patient inconvenience, Carpal
Tunnel Syndrome is associated with tremendous economic burden: the direct
financial implications of management and the indirect burden of absenteeism
from the workplace.
Current treatment, such as cortisone injections or surgery have a risk of
complications. A promising non-invasive treatment is mechanical traction /
rotation by the Phystrac apparatus. Although over 5000 patients in the
Ntherlands have been treated already in regular care by the Phystrac apparatus,
until now no randomised controlled trial has been performed to evaluate the
effectiveness of the Phystrac in people with Carpal Tunnel Syndrome.
Study objective
The aim of this study is to investigate the effectiveness of the Phystrac in
people with Carpal Tunnel Syndrome.
The primary research question is:
- Is there evidence that Phystrac might be an additional non-invasive option of
treating CTS patients with regard of clinical outcome?
The secondary research questions are:
- To what extent contributes Phystrac to decrease the number of days of sick
leave?
- To what extent contributes Phystrac to improvement of quality of life?
- To what extent contributes Phystrac to less resource utilisation behaviour?
Study design
The current study has a Randomised Controlled Trial design with one year follow
up. The Phystrac intervention will be compared with care as usual.
Intervention
The intervention consist of mechanical traction / rotation using the Phystrac
apparatus. Each session has a duration of 20 minutes. Treatment sessions are
twice a week during 6 weeks.
Study burden and risks
No risk is associated with participating in the study. The Phystrac is
classified into risk class 1. All participants are asked to fill out a
questionnaire four times during a year. Participants allocated to the
intervention group will have a 20 minutes treatment twice a week during 6
weeks.
Warandelaan 2
Tilburg 5000LE
NL
Warandelaan 2
Tilburg 5000LE
NL
Listed location countries
Age
Inclusion criteria
- patients who fulfil the criteria of diagnosis of CTS.
- aged between 18 - 80 years, compos mentis
- being physically capable of visiting the outpatient clinic twice a week in Venlo
- being capable to sit in an upright position for 20 minutes in a standard chair
- 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, bipolar disorder
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44692.008.13 |