Efficiency of Mirror Therapy After Carpal Tunnel Surgery

Carpal Tunnel Syndrome Clinical Trial

Official title:

Effects of Mirror Therapy After Carpal Tunnel Syndrome Surgery: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634618
• Other study ID #: IstanbulTK1
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: June 8, 2017

Study information

• Verified date: November 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 8, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Physiotherapy
• Rehabilitation
• Syndrome

Intervention

Other:
• Mirror 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.
• Convantional 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).

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before surgery, 3 weeks and 6 weeks after surgery (3 repetitive measurements)
Secondary	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".	before surgery, 3 weeks and 6 weeks after surgery
Secondary	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.	before surgery, 3 weeks and 6 weeks after surgery
Secondary	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.	before surgery, 3 weeks and 6 weeks after surgery