NCT03634618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

July 24, 2018

Last Update Submit

November 5, 2019

Conditions

Keywords

carpal tunnel syndromemirror therapypostoperative rehabilitationphysical therapy modalitiesmedian nerve

Outcome Measures

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.

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

Secondary Outcomes (3)

  • 9-Hole Peg Test

    before surgery, 3 weeks and 6 weeks after surgery

  • Semmes Weinstein Monofilaman Test

    before surgery, 3 weeks and 6 weeks after surgery

  • Visual Analog Scale

    before surgery, 3 weeks and 6 weeks after surgery

Study Arms (2)

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.

Other: Mirror TherapyOther: 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.

Other: Convantional Physiotherapy

Interventions

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.

Mirror Therapy

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).

Convantional PhysiotherapyMirror Therapy

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Bakirkoy, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Tugba Karaaslan

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 16, 2018

Study Start

January 4, 2016

Primary Completion

April 27, 2017

Study Completion

June 8, 2017

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations