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

Flexor Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237415
• Other study ID #: 60116787-020/50298
• Status: Completed
• Phase: N/A
• Start date: October 10, 2016
• Est. completion date: March 21, 2019

Study information

• Verified date: January 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 21, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Hand Therapy
• Rupture
• Tendon Injuries

Intervention

Procedure:
• EMG biofeedback training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finger joint range of motion	Finger motion was measured by goniometer.Total active motion protocol was used.	5th week
Primary	Finger joint range of motion	Finger motion was measured by goniometer.Total active motion protocol was used.	12th week
Primary	Finger joint range of motion	Finger motion was measured by goniometer.Total active motion protocol was used.	24th week
Primary	Electrical muscle activity	Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.	5th week
Primary	Electrical muscle activity	Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.	12th week
Primary	Electrical muscle activity	Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.	24th week
Primary	Grip strength	Gross and pinch strength were evaluated by hand dynamometer.	12th week
Primary	Grip strength	Gross and pinch strength were evaluated by hand dynamometer.	24th week
Primary	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
Primary	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
Primary	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