Low-Level Laser Therapy and Orthotic Insole in Tibialis Posterior Tendon Insufficiency
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|ClinicalTrials.gov Identifier: NCT03363074|
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Posterior Tibial Tendon Insufficiency||Device: Orthotic Insole Device: Low-Level Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Effects of Low-Level Therapy Laser and Orthotic Insole on Pain, Function and Muscle Strength in Subjects With Stage 1-2 Tibialis Posterior Tendon Insufficiency: Randomized Study|
|Actual Study Start Date :||November 20, 2017|
|Actual Primary Completion Date :||August 25, 2018|
|Actual Study Completion Date :||September 5, 2018|
Experimental: Orthotic Insole
Device: Orthotic Insole 8-week follow-up with Orthotic Insole
Device: Orthotic Insole
A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole,and 3mm,15 Shore A hardness ethyl vinyl acetate was used for covering.Orthotic insoles have been emplemented in a pair of sports shoes.
Experimental: Low-level Laser Therapy
Low-Level Laser 5-week follow-up
Device: Low-Level Laser
A low density laser with a power density of 0.05-0.10 (w / cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It will be 3 administered times a week for 5 weeks. Laser treatment will be applied along the tibialis posterior tendon. 3 different point (proximal tibial tendon, distally tibial tendon and posterior medial malleol) applications will be done.
- Change in Foot Function Assesed With Foot Function Index [ Time Frame: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group ]This scale evaluates the severity of foot pain in different situations. It consists of 3 subtitles and contains 23 questions in total. Turkish version adaptation study is done, valid and reliable measure. The total score obtained by the patient between 0-10 of each question was scaled by obtaining a score of 100 with the number of answered questions
- Change in Muscle Strength Assesed With Humac Norm Isocynetic Dynanometer [ Time Frame: Basline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group ]The force values of the inverter and the evertor muscles of the foot will be measured. Before starting the test, a standard warm-up program will be applied for 3 minutes without resistance in the patient bicycle ergometer. At the same time, passive stretching of the patient's gastrocnemius and soleus muscles. Subjects movements will be evaluated at 10 repetitions at 180º / sec, 10 repetitions at a rate of 240º / sec. Before each angular velocity, subjects are allowed to perform 3 repeated trials and after 10 seconds rest, tests will be applied. Unilateral measurement will be performed.
- Change in Foot Pain Assesed With Digital Algometer [ Time Frame: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group ]The pain from the three different points of the tendon with the sensor will be assessed. 3 different point (proximal tibial tendon, distally tibial tendon and posterior medial malleol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363074
|Eastern Mediterranean University|
|Mersin, Famagusta, Turkey, 99450|
|Principal Investigator:||Yasin Yurt, PhD||Eastern Mediterranean University|