Tendon Injury - Hand Clinical Trial
Official title:
The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8: A Randomized Controlled Trial
Verified date | June 2022 |
Source | Turkish League Against Rheumatism |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Turkish League Against Rheumatism |
Turkey,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Pre-intervention, immediately after the intervention, eighth week | |
Primary | Grip strength | Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms. | Eighth week | |
Primary | 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. | Pre-intervention, immediately after the intervention, eighth week | |
Primary | 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. | Pre-intervention, immediately after the intervention, eighth week | |
Secondary | 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. | Pre-intervention, immediately after the intervention, eighth week | |
Secondary | 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. | Pre-intervention, immediately after the intervention, eighth week | |
Secondary | Return to work | The rehabilitation period required for patients to return to work | Eighth week |
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