Clinical trial NCT04237415: Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries
Official title: The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexor Tendon Rupture
Hand Therapy
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Finger joint range of motion
timeFrame: 5th week
measure: Finger joint range of motion
timeFrame: 12th week
measure: Finger joint range of motion
timeFrame: 24th week
measure: Electrical muscle activity
timeFrame: 5th week
measure: Electrical muscle activity
timeFrame: 12th week
measure: Electrical muscle activity
timeFrame: 24th week
measure: Grip strength
timeFrame: 12th week
measure: Grip strength
timeFrame: 24th week
measure: Michigan Hand Questionnaire
timeFrame: 5th week
measure: Michigan Hand Questionnaire
timeFrame: 12th week
measure: Michigan Hand Questionnaire
timeFrame: 24th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: Ali Kitis, PhD
role: STUDY_DIRECTOR
References: