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CompletedNCT03634618Updated Nov 6, 2019

Efficiency of Mirror Therapy After Carpal Tunnel Surgery

An interventional study of Mirror Therapy and Convantional Physiotherapy in Carpal Tunnel Syndrome, Physiotherapy and Rehabilitation, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-06.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jan 2016, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Carpal Tunnel Syndrome
  • Physiotherapy
  • Rehabilitation

Keywords

  • carpal tunnel syndrome
  • mirror therapy
  • postoperative rehabilitation
  • physical therapy modalities
  • median nerve
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's enrollment of 35 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Carpal tunnel diagnosis and open surgery are planned,
  • Having the ability to adapt to exercises,
  • Voluntarily agree to participate in the work

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Mirror Therapy

    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.

    Other: Mirror Therapy · Other: Convantional Physiotherapy

  • Experimental
    Convantional Physiotherapy

    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.

    Other: Convantional Physiotherapy

Interventions

  • OtherMirror Therapy

    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.

  • OtherConvantional Physiotherapy

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: before surgery, 3 weeks and 6 weeks after surgery (3 repetitive measurements)

Secondary outcomes

  1. 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".

    Time frame: before surgery, 3 weeks and 6 weeks after surgery

  2. 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.

    Time frame: before surgery, 3 weeks and 6 weeks after surgery

  3. 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.

    Time frame: before surgery, 3 weeks and 6 weeks after surgery

07

Study locations

1 site
  • Istanbul University
    Istanbul, Bakirkoy 34740, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03634618
Lead sponsor
Istanbul University
Responsible party
Tugba Karaaslan (Research Assistant, Istanbul University) — Principal investigator
First posted
Aug 16, 2018
Start date
Jan 4, 2016
Primary completion
Apr 27, 2017
Completion
Jun 8, 2017
Last update
Nov 6, 2019

Study contacts

Tugba Karaaslan
principal investigator · Research Assistant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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