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

NCT ID: NCT04742296

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tendon Injury - Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment group of low level laser therapy

Group Type ACTIVE_COMPARATOR

low level laser therapy

Intervention Type 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.

Sham group of low level laser therapy

Group Type PLACEBO_COMPARATOR

low level laser therapy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Sham laser therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turkish League Against Rheumatism

OTHER

Sponsor Role lead

Responsible Party

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faruk erdogan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30905495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30300099 (View on PubMed)

Other Identifiers

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TRASD-FE-TEZ

Identifier Type: -

Identifier Source: org_study_id

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