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

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

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.

Study Overview

• Status: Completed
• Conditions: Tendon Injury - Hand
• Intervention / Treatment: Device: low level laser therapy

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group of low level laser therapy	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.; Other Names: Sham laser therapy
Placebo Comparator: Sham group of low level laser therapy	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.; Other Names: Sham laser therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Turkish League Against Rheumatism

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: TRASD-FE-TEZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No