Carpal Tunnel SyndromeNCT03634618
Efficiency of Mirror Therapy After Carpal Tunnel Surgery
A study testing Mirror Therapy and Convantional Physiotherapy in people with Carpal Tunnel Syndrome and Physiotherapy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Physiotherapy, Rehabilitation
- What is being tested?
- Mirror Therapy and Convantional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2016to 8 Jun 2017
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carpal tunnel diagnosis and open surgery are planned,
- Having the ability to adapt to exercises,
- Voluntarily agree to participate in the work
Who cannot join
- With the forearm and hand trauma story
- In the last 6 months, local corticosteroid injections to the treatment area have been performed
- Infection in the treatment area
- Having a deformity in hand
- The presence of malignancy
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mirror Therapy After Carpal Tunnel Syndrome Surgery: Randomized Controlled Study
In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery.
Read the detailed description
PURPOSE: The aim of this study is to investigate the efficacy of mirror therapy (MT).
METHOD: In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery. The SPSS 21.0 statistical program will be used in the data analysis of the study and the level of significance wiil be accepted as p<0,05.
- Conditions
- Carpal Tunnel Syndrome, Physiotherapy, Rehabilitation
- Being tested
- Mirror Therapy, Convantional Physiotherapy
- Keywords
- carpal tunnel syndrome, mirror therapy, postoperative rehabilitation, physical therapy modalities, median nerve
- 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.
Mirror TherapyOther
Mirror therapy is the treatment method in which mental performance of movements is performed by observing the movements of the healthy extremities. In the case of mirror treatment, the mirror box is placed on a fixed floor. The mirror is positioned so that the patient's body can be fully centered and the mirror image can be seen. While the affected limb is placed on the rear side of the mirror, the firm extremity is opposite to the mirror. The patient focuses on the mirror image of the moving healthy hand and, through artificial visual feedback, perceives the affected limb as moving. The exercises are as follows: flexor tendon gliding exercises, median motor exercises, wrist and forearm ROM exercises and function-oriented exercises.
Convantional PhysiotherapyOther
The first two weeks involve only immobilisation with plaster. The next 4 weeks, patients do the exercises which follows: 15 minutes water bath, scar tissue massage, flexor tendon gliding exercises, median motor exercises, wrist flexion-extention, median nerve gliding exercise (in addition, one week after plaster removal), hand wrist stretching exercise (in addition, 2 weeks after plaster removal).
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy | Experimental | Mirror Therapy program for 2 weeks and convantional physiotherapy for 4 weeks. Exercises Frequency: 5 days/week; 2 days with the physiotherapist, other days as home program; 2 weeks in total. Exercises Duration: 20 minutes. Exercises Repetation: 20 repetation for each exercise. Receives: Other: Mirror Therapy; Other: Convantional Physiotherapy |
| Convantional Physiotherapy | Experimental | Convantional physiotherapy for 6 weeks. Exercises Frequency: 3 times a day, 4 weeks in total. Exercises Duration: 15-20 minutes. Exercises Repetation: 10 repetation for each exercise. Receives: Other: Convantional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire (the change of severity and functional status)
It is a self-administered questionnaire that assesses the severity and functional status of typical 24-hour symptoms of patients with Carpal Tunnel Syndrome (CTS) during the last two weeks. The Symptom Severity Scale (SSS) consists of 11 questions evaluating the severity, frequency, duration and types of symptoms. The answers that can be given to each question are scored between 1 and 5. The SSS score is calculated by dividing the total score by the number of questions answered. A high score means that the symptoms are more severe. The Functional Status Scale (FSS) consists of 8 questions that assess how much the CTS affects daily life. The degree of difficulty in doing activities is scored between 1 and 5. The FSS score is calculated by dividing the total score by the number of questions answered. Higher score means less functional capacity.
In this study, the outcome measure is assessing the change of functional activity and symptoms from pre-operative at 3 and 6 weeks.
Measured: before surgery, 3 weeks and 6 weeks after surgery (3 repetitive measurements)
Secondary outcomes (3)
9-Hole Peg Test
It is used to evaluate patients' hand and finger skills. The pegboard is placed in the middle of the body. It is desirable that 9 wooden pins be placed randomly in the 9-hole wooden block as fast as possible, and then the pins are removed from the wooden block and placed in the storage compartment one by one. These times are measured and recorded with a stopwatch. A total of 20 seconds or more is considered a "loss of skill".
Measured: before surgery, 3 weeks and 6 weeks after surgery
Semmes Weinstein Monofilaman Test
The sense of the distal phalanges of the 1st, 2nd and 3rd fingers, the proximal phalanges of the 2nd and 3rd fingers on the palm of the hand and the tenar region will be assessed. When the patient's eyes close, the monofilament is done progressed from the thinnest monofilament to the thicker monofilament, respectively. The assessment starts with the monofilament is perpendicular to the surface and pressure is applied until the angle is 45 degrees, wait for 1.5 seconds at this position. When at least 2 out of 3 applications differenciate, this value records.
Measured: before surgery, 3 weeks and 6 weeks after surgery
Visual Analog Scale
The severity of pain and paresthesia symptoms of the patients will be assessed using the 10 cm Visual Analogue Scale. Before the assessment, patients instruct that "0" for "no symptoms", "10" represents "the most severe pain that could be felt" and should mark the point that best describes the symptom. The patient's rest, activity and night pain in the last week will be questioned separately. To evaluate the paresthesia, the most severe paresthesia felt by the patient in the last 1 week will be questioned and it will be asked to mark the place that best expresses paresthesia on the scale. Marked points measure by a ruler and record in centimeters.
Measured: before surgery, 3 weeks and 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start4 Jan 2016
- Primary completion27 Apr 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Karaaslan, Istanbul University
- Investigators
- Tugba Karaaslan, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634618
- Sponsor's protocol ID
- IstanbulTK1
- Status last verified
- Nov 2019
- First submitted
- 24 Jul 2018
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy After Carpal Tunnel Syndrome Surgery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03634618
- Acronym / sponsor ID
- IstanbulTK1
- Conditions
- Carpal Tunnel Syndrome, Physiotherapy, Rehabilitation
- Keywords
- carpal tunnel syndrome, mirror therapy, postoperative rehabilitation, physical therapy modalities, median nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 16 Aug 2018 (actual)
- 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.
In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery.
Detailed description
PURPOSE: The aim of this study is to investigate the efficacy of mirror therapy (MT).
METHOD: In the randomized controlled study with patients who appropriate the inclusion criteria are divided into two groups by simple drawing method. In the control group, the classical physiotherapy program is being applied when the post-operative immobilization period ended, MT is applied to the mirror group in addition to this treatment for 20 minutes and a total of 10 sessions in the immobilization period. Patients who are scheduled for operation due to CTS evaluated that pain (VAS), sense (monofilament test), function (BCTQ, 9-hole peg test) before surgery, 3 weeks and 6 weeks after surgery. The SPSS 21.0 statistical program will be used in the data analysis of the study and the level of significance wiil be accepted as p<0,05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy | Experimental | Other: Mirror Therapy, Other: Convantional PhysiotherapyMirror Therapy program for 2 weeks and convantional physiotherapy for 4 weeks. Exercises Frequency: 5 days/week; 2 days with the physiotherapist, other days as home program; 2 weeks in total. Exercises Duration: 20 minutes. Exercises Repetation: 20 repetation for each exercise. |
| Convantional Physiotherapy | Experimental | Other: Convantional PhysiotherapyConvantional physiotherapy for 6 weeks. Exercises Frequency: 3 times a day, 4 weeks in total. Exercises Duration: 15-20 minutes. Exercises Repetation: 10 repetation for each exercise. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Carpal tunnel diagnosis and open surgery are planned,
- Having the ability to adapt to exercises,
- Voluntarily agree to participate in the work
Key exclusion criteria (6 listed)
- With the forearm and hand trauma story
- In the last 6 months, local corticosteroid injections to the treatment area have been performed
- Infection in the treatment area
- Having a deformity in hand
- The presence of malignancy
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 |
|---|---|---|
| Mirror TherapyMirror therapy is the treatment method in which mental performance of movements is performed by observing the movements of the healthy extremities. In the case of mirror treatment, the mirror box is placed on a fixed floor. The mirror is positioned so that the patient's body can be fully centered and the mirror image can be seen. While the affected limb is placed on the rear side of the mirror, the firm extremity is opposite to the mirror. The patient focuses on the mirror image of the moving healthy hand and, through artificial visual feedback, perceives the affected limb as moving. The exercises are as follows: flexor tendon gliding exercises, median motor exercises, wrist and forearm ROM exercises and function-oriented exercises. | Other | Mirror Therapy |
| Convantional PhysiotherapyThe first two weeks involve only immobilisation with plaster. The next 4 weeks, patients do the exercises which follows: 15 minutes water bath, scar tissue massage, flexor tendon gliding exercises, median motor exercises, wrist flexion-extention, median nerve gliding exercise (in addition, one week after plaster removal), hand wrist stretching exercise (in addition, 2 weeks after plaster removal). | Other | Convantional Physiotherapy, Mirror Therapy |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire (the change of severity and functional status)
Time frame: before surgery, 3 weeks and 6 weeks after surgery (3 repetitive measurements)
It is a self-administered questionnaire that assesses the severity and functional status of typical 24-hour symptoms of patients with Carpal Tunnel Syndrome (CTS) during the last two weeks. The Symptom Severity Scale (SSS) consists of 11 questions evaluating the severity, frequency, duration and types of symptoms. The answers that can be given to each question are scored between 1 and 5. The SSS score is calculated by dividing the total score by the number of questions answered. A high score means that the symptoms are more severe. The Functional Status Scale (FSS) consists of 8 questions that assess how much the CTS affects daily life. The degree of difficulty in doing activities is scored between 1 and 5. The FSS score is calculated by dividing the total score by the number of questions answered. Higher score means less functional capacity. In this study, the outcome measure is assessing the change of functional activity and symptoms from pre-operative at 3 and 6 weeks.
3 secondary outcomes
9-Hole Peg Test
Time frame: before surgery, 3 weeks and 6 weeks after surgery
Semmes Weinstein Monofilaman Test
Time frame: before surgery, 3 weeks and 6 weeks after surgery
Visual Analog Scale
Time frame: before surgery, 3 weeks and 6 weeks after surgery
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 6 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Tugba Karaaslan principal investigator
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Convantional Physiotherapy in people with Carpal Tunnel Syndrome and Physiotherapy, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 6 Nov 2019. 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 Turkey (Türkiye). 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?
Boston Carpal Tunnel Syndrome Questionnaire (the change of severity and functional status) (time frame: before surgery, 3 weeks and 6 weeks after surgery (3 repetitive measurements)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2019.