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Completed

NCT Number: NCT04742296

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

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.

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Key information

Conditions

Tendon Injury - Hand

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Level Laser Therapy

Device

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

Primary outcomes

  1. Change in total active motion degrees

    Time frame: 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.

  2. Grip strength

    Time frame: Eighth week

    Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.

  3. Change in visual analog scale (VAS) score

    Time frame: 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.

  4. Change in metacarpophalangeal joint circumference

    Time frame: 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.

Secondary outcomes

  1. Change in quick disabilities of arm, shoulder and hand (QuickDASH) score

    Time frame: 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.

  2. Change in short form-36 (SF-36) scores

    Time frame: 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.

  3. Return to work

    Time frame: Eighth week

    The rehabilitation period required for patients to return to work

Sponsors and collaborators

Lead sponsor

Turkish League Against Rheumatism

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2021
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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