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

Tendon Injury - Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742296
• Other study ID #: TRASD-FE-TEZ
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2022
• Source: Turkish League Against Rheumatism
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendon Injuries
• Tendon Injury - Hand
• Wounds and Injuries

Intervention

Device:
• low level laser therapy
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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkish League Against Rheumatism

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Collocott SJF, Kelly E, Foster M, Myhr H, Wang A, Ellis RF. A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs. J Hand Ther. 2020 Jan - Mar;33(1):13-24. doi: 10.1016/j.jht.2018.10.003. Epub 2019 Mar 21. — View Citation

Poorpezeshk N, Ghoreishi SK, Bayat M, Pouriran R, Yavari M. Early Low-Level Laser Therapy Improves the Passive Range of Motion and Decreases Pain in Patients with Flexor Tendon Injury. Photomed Laser Surg. 2018 Oct;36(10):530-535. doi: 10.1089/pho.2018.4458. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Grip strength	Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.	Eighth week
Primary	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
Primary	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	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
Secondary	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
Secondary	Return to work	The rehabilitation period required for patients to return to work	Eighth week