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

Not Applicable

Completed

• Conditions: Tendon Injury - Hand
• Interventions: Device: low level laser therapy

• Registration Number: NCT04742296
• Lead Sponsor: Turkish League Against Rheumatism

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-30
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group of low level laser therapy	low level laser therapy	-
Sham group of low level laser therapy	low level laser therapy	-

Primary Outcome Measures

Name	Time	Method
Change in visual analog scale (VAS) score	Pre-intervention, immediately after the intervention, eighth week	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.
Grip strength	Eighth week	Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.
Change in metacarpophalangeal joint circumference	Pre-intervention, immediately after the intervention, eighth week	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.
Change in total active motion degrees	Pre-intervention, immediately after the intervention, eighth week	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.

Secondary Outcome Measures

Name	Time	Method
Change in quick disabilities of arm, shoulder and hand (QuickDASH) score	Pre-intervention, immediately after the intervention, eighth week	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.
Change in short form-36 (SF-36) scores	Pre-intervention, immediately after the intervention, eighth week	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.
Return to work	Eighth week	The rehabilitation period required for patients to return to work

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey