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

Primary Purpose

Tendon Injury - Hand

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
low level laser therapy
Sponsored by
Turkish League Against Rheumatism
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injury - Hand

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment group of low level laser therapy

Sham group of low level laser therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Return to work
The rehabilitation period required for patients to return to work

Full Information

First Posted
January 27, 2021
Last Updated
June 15, 2022
Sponsor
Turkish League Against Rheumatism
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1. Study Identification

Unique Protocol Identification Number
NCT04742296
Brief Title
The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8
Official Title
The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turkish League Against Rheumatism

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injury - Hand

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group of low level laser therapy
Arm Type
Active Comparator
Arm Title
Sham group of low level laser therapy
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
Sham laser therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total active motion degrees
Description
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.
Time Frame
Pre-intervention, immediately after the intervention, eighth week
Title
Grip strength
Description
Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.
Time Frame
Eighth week
Title
Change in visual analog scale (VAS) score
Description
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.
Time Frame
Pre-intervention, immediately after the intervention, eighth week
Title
Change in metacarpophalangeal joint circumference
Description
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.
Time Frame
Pre-intervention, immediately after the intervention, eighth week
Secondary Outcome Measure Information:
Title
Change in quick disabilities of arm, shoulder and hand (QuickDASH) score
Description
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.
Time Frame
Pre-intervention, immediately after the intervention, eighth week
Title
Change in short form-36 (SF-36) scores
Description
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.
Time Frame
Pre-intervention, immediately after the intervention, eighth week
Title
Return to work
Description
The rehabilitation period required for patients to return to work
Time Frame
Eighth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30905495
Citation
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.
Results Reference
background
PubMed Identifier
30300099
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.
Results Reference
background

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

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