The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8

Study Overview
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Brief Summary
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This study examines the rehabilitation results when low-level laser therapy is applied in zone 5-8 extensor tendon injuries. Rehabilitation results will be evaluated with both objective measurements and patient reported outcome measures. The study was planned as a double-blind, placebo-controlled, randomized, two-arm study. Participants in both treatment groups will be given exercise therapy in accordance with the early active mobilization protocol and appropriate splint will be given to be used while exercising.

Official Title
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The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8: A Randomized Controlled Trial

Conditions
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Tendon Injury - Hand

Intervention / Treatment
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* Device: low level laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being between the ages of 18-65 Primary repair due to extensor tendon injury between Zones V-VIII Applying to the Hand Rehabilitation Policlinic at the end of the postoperative 1st week Exclusion Criteria: Accompanying flexor tendon injury, fracture, vascular and / or nerve injury Active using of steroids or non-steroidal anti-inflammatory drugs Systemic infection or malignancy Pregnant or breastfeeding women Active wound infection Having a cognitive dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group of low level laser therapy<br> | Device: low level laser therapy<br>* We will use laser light that has continuous wave mode, power of 100 mW, energy density of 7,5 joule/cm2, treatment time as 300 seconds.<br>* Other names: Sham laser therapy;|
| Placebo Comparator: Sham group of low level laser therapy<br> | Device: low level laser therapy<br>* We will use laser light that has continuous wave mode, power of 100 mW, energy density of 7,5 joule/cm2, treatment time as 300 seconds.<br>* Other names: Sham laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total active motion degrees | The difference of active range of motion (ROM) measurements between injured and non-injured digit(s). ROM measurement will be made with the help of a standard hand goniometer and the measured degree will be recorded. | Pre-intervention, immediately after the intervention, eighth week | 
| Grip strength | Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms. | Eighth week | 
| Change in visual analog scale (VAS) score | VAS is a scale used to assess pain. Minimum value of the scale is 0 and maximum is 10. Higher scores mean a worse outcome. | Pre-intervention, immediately after the intervention, eighth week | 
| Change in metacarpophalangeal joint circumference | It will be used to evaluate edema in the dorsum of the hand. Measurement will be made with the help of a tape measure. The measured value will be recorded in milimeters. | Pre-intervention, immediately after the intervention, eighth week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quick disabilities of arm, shoulder and hand (QuickDASH) score | A scale used for measuring physical function and symptoms of upper extremities. Minimum value of the scale is 0 and maximum is 100. Higher scores mean a worse outcome. | Pre-intervention, immediately after the intervention, eighth week | 
| Change in short form-36 (SF-36) scores | A scale used for determining quality of life. This form evaluates the quality of life under 9 different headings. Minimum value of all headings is %0 and maximum is %100. Higher scores mean a better outcome. | Pre-intervention, immediately after the intervention, eighth week | 
| Return to work | The rehabilitation period required for patients to return to work | Eighth week |