Clinical trial NCT04742296: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injury - Hand
Lead sponsor: Turkish League Against Rheumatism
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in total active motion degrees
timeFrame: Pre-intervention, immediately after the intervention, eighth week
measure: Grip strength
timeFrame: Eighth week
measure: Change in visual analog scale (VAS) score
timeFrame: Pre-intervention, immediately after the intervention, eighth week
measure: Change in metacarpophalangeal joint circumference
timeFrame: Pre-intervention, immediately after the intervention, eighth week
Secondary outcomes:
measure: Change in quick disabilities of arm, shoulder and hand (QuickDASH) score
timeFrame: Pre-intervention, immediately after the intervention, eighth week
measure: Change in short form-36 (SF-36) scores
timeFrame: Pre-intervention, immediately after the intervention, eighth week
measure: Return to work
timeFrame: Eighth week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
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.
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.