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Efficiency of Mirror Therapy After Carpal Tunnel Surgery

Primary Purpose

Carpal Tunnel Syndrome, Physiotherapy, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mirror Therapy
Convantional Physiotherapy
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, mirror therapy, postoperative rehabilitation, physical therapy modalities, median nerve

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mirror Therapy

Convantional Physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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.
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.

Full Information

First Posted
July 24, 2018
Last Updated
November 5, 2019
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03634618
Brief Title
Efficiency of Mirror Therapy After Carpal Tunnel Surgery
Official Title
Effects of Mirror Therapy After Carpal Tunnel Syndrome Surgery: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
April 27, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Physiotherapy, Rehabilitation
Keywords
carpal tunnel syndrome, mirror therapy, postoperative rehabilitation, physical therapy modalities, median nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Convantional Physiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Convantional Physiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire (the change of severity and functional status)
Description
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 Outcome Measure Information:
Title
9-Hole Peg Test
Description
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
Title
Semmes Weinstein Monofilaman Test
Description
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
Title
Visual Analog Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugba Karaaslan
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34740
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficiency of Mirror Therapy After Carpal Tunnel Surgery

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