Carpal Tunnel SyndromeMT-CTSNCT01949493
Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction
A study testing mechanical traction and Care as usual in people with Carpal Tunnel Syndrome, run by Tilburg University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- mechanical traction and Care as usual
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not understanding Dutch appropriately
- other known (rare) cause of neuropathy
- suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of this study is to evaluate the effectiveness of mechanical traction in patients with Carpal Tunnel Syndrome compared to care as usual.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- mechanical traction, Care as usual
- Keywords
- carpal tunnel syndrome, traction, mechanical traction, Phystrac
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical tractionDevice
Also called Phystrac mechanical traction device (type GR 10)
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.
Care as usualOther
Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Care as usual |
| Mechanical traction | Experimental | Twelve treatments with mechanical traction using the Phystrac traction apparatus. Receives: Device: mechanical traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof.dr. Victor J Pop, Tilburg University
- Investigators
- Victor Pop, Prof. Dr., Principal investigator, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949493
- Sponsor's protocol ID
- NL44692.008.13
- Acronym
- MT-CTS
- Status last verified
- Dec 2016
- First submitted
- 19 Sep 2013
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34552548
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01949493
- Acronym / sponsor ID
- MT-CTS / NL44692.008.13
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, traction, mechanical traction, Phystrac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effectiveness of mechanical traction in patients with Carpal Tunnel Syndrome compared to care as usual.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | Other | Other: Care as usualThe 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. |
| Mechanical traction | Experimental | Device: mechanical tractionTwelve treatments with mechanical traction using the Phystrac traction apparatus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- not understanding Dutch appropriately
- other known (rare) cause of neuropathy
- suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical tractionAlso: Phystrac mechanical traction device (type GR 10)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. | Device | Mechanical traction |
| Care as usualUsual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery). | Other | Care as usual |
Primary outcome
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.
3 secondary outcomes
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.
Change from baseline in absenteeism from work
Time frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Change from baseline in health care related resource utilization
Time frame: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Derived from this study: PubMed 34552548Meems 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.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Pop, Prof. Dr. principal investigator
Tilburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical traction and Care as usual in people with Carpal Tunnel Syndrome, run by Tilburg University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01949493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.