Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries

The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries

Aim: The aim of the study was to investigate the effect of electromyographic (EMG) biofeedback training applied in addition to early passive motion protocol on electrical muscle activity (EMA) and functional status in zone I-III flexor tendon injuries.

Materials and Methods: Cases who underwent surgery for flexor tendon injuries in zone I-III were included in this prospective randomized controlled trial. Cases were randomly divided into two groups of 11 cases each by block randomization. In the first group, EMG biofeedback training was applied in addition to the early passive motion method (modified Duran protocol), while the second group was followed only by early passive motion method. The treatment program was performed by the same physiotherapist three times a week, for 12 weeks. At the postoperative 5th, 12th and 24th weeks, joint range of motion (ROM) and EMA were evaluated, and the Michigan Hand Outcome Questionnaire (MHQ) was administered to the patients. The grip strength at 12th and 24th weeks were also assessed. The Mann-Whitney U Test was used to compare the two groups.

Study Overview

• Status: Completed
• Conditions: Flexor Tendon Rupture; Hand Therapy
• Intervention / Treatment: Procedure: EMG biofeedback training

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being olunteer,
• No history of neurological, orthopedic, rheumatologic disease or trauma in the related extremity,
• No history of neuropathy due to a metabolic disease (diabetes, etc.),
• Incision of at least one of the FDS or FDP tendons,
• At least one of the FDS or FDP tendons repaired within 2 weeks after the injury,
• No communication problems.

Exclusion Criteria:

• <18 years of age,
• Pregnancy,
• Thumb flexor tendon cuts,
• Digital nerve injury,
• Accompanying fracture, joint capsule injury or skin loss,
• Crush injury,
• Patients with pacemakers,
• Patients with cardiac arrhythmias,
• Epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: EMG biofeedback group	Procedure: EMG biofeedback training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finger joint range of motion	Finger motion was measured by goniometer.Total active motion protocol was used.	5th week
Finger joint range of motion	Finger motion was measured by goniometer.Total active motion protocol was used.	12th week
Finger joint range of motion	Finger motion was measured by goniometer.Total active motion protocol was used.	24th week
Electrical muscle activity	Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.	5th week
Electrical muscle activity	Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.	12th week
Electrical muscle activity	Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.	24th week
Grip strength	Gross and pinch strength were evaluated by hand dynamometer.	12th week
Grip strength	Gross and pinch strength were evaluated by hand dynamometer.	24th week
Michigan Hand Questionnaire	This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.	5th week
Michigan Hand Questionnaire	This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.	12th week
Michigan Hand Questionnaire	This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.	24th week

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Director: Ali Kitis, PhD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Tendon Injuries
• Other Study ID Numbers: 60116787-020/50298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No