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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04742296
Enrollment
55
Registered
2021-02-08
Start date
2020-04-30
Completion date
2020-12-30
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Injury - Hand

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.

Interventions

DEVICElow 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.

Sponsors

Turkish League Against Rheumatism
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in total active motion degreesPre-intervention, immediately after the intervention, eighth weekThe 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 strengthEighth weekGrip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.
Change in visual analog scale (VAS) scorePre-intervention, immediately after the intervention, eighth weekVAS 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 circumferencePre-intervention, immediately after the intervention, eighth weekIt 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

MeasureTime frameDescription
Change in short form-36 (SF-36) scoresPre-intervention, immediately after the intervention, eighth weekA 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 workEighth weekThe rehabilitation period required for patients to return to work
Change in quick disabilities of arm, shoulder and hand (QuickDASH) scorePre-intervention, immediately after the intervention, eighth weekA 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026