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Completed

NCT Number: NCT04237415

Electromyographic (EMG) Biofeedback Training 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.

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Key information

Conditions

Flexor Tendon Rupture Hand Therapy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMG biofeedback training

Procedure

Primary outcomes

  1. Finger joint range of motion

    Time frame: 5th week

    Finger motion was measured by goniometer.Total active motion protocol was used.

  2. Finger joint range of motion

    Time frame: 12th week

    Finger motion was measured by goniometer.Total active motion protocol was used.

  3. Finger joint range of motion

    Time frame: 24th week

    Finger motion was measured by goniometer.Total active motion protocol was used.

  4. Electrical muscle activity

    Time frame: 5th week

    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

  5. Electrical muscle activity

    Time frame: 12th week

    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

  6. Electrical muscle activity

    Time frame: 24th week

    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

  7. Grip strength

    Time frame: 12th week

    Gross and pinch strength were evaluated by hand dynamometer.

  8. Grip strength

    Time frame: 24th week

    Gross and pinch strength were evaluated by hand dynamometer.

  9. Michigan Hand Questionnaire

    Time frame: 5th week

    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.

  10. Michigan Hand Questionnaire

    Time frame: 12th week

    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.

  11. Michigan Hand Questionnaire

    Time frame: 24th week

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 23, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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