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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04742296
Other study ID # TRASD-FE-TEZ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT03622372 - Zone 2 Flexor Tendon Repair With CoNextions TR Implant System Phase 3
Completed NCT06198582 - The Effect of Virtual Reality Based Task Specific Exercises in Patients With Hand Flexor Tendon Injury N/A
Recruiting NCT04962490 - Study of the Repair of Flexor Tendons of the Hand
Completed NCT04385485 - Passive Mobilization With Place and Hold vs Active Mobilization Therapy After Flexor Tendon Repair N/A
Completed NCT04618107 - Wide Awake Surgery for Tendon Repair in Hand Trauma N/A
Recruiting NCT04312412 - Outcome of the Treatment of Flexor Tendon Injuries
Active, not recruiting NCT06313489 - Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
Not yet recruiting NCT04787835 - The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery N/A
Not yet recruiting NCT03135340 - Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Flexor Tendon Repair N/A