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Low-Level Laser Therapy and Orthotic Insole in Tibialis Posterior Tendon Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03363074
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : November 6, 2018
Information provided by (Responsible Party):
Cansu Koltak, Eastern Mediterranean University

Brief Summary:
The purpose of this study is to compare low-level laser therapy and insole interventions on pain, function and muscle strength in subjects with posterior tendon insufficiency.

Condition or disease Intervention/treatment Phase
Posterior Tibial Tendon Insufficiency Device: Orthotic Insole Device: Low-Level Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Taking the diagnosis of stage 1 - 2 tibialis posterior insufficiency by the physician,
  • Be between the ages of 18 and 60,
  • The absence of a different orthopedic or neurological disease that may affect the lower extremity biomechanics,
  • Not having a systemic disease that keeps feet.
  • Having not received any treatment from the foot area in the last 1 year.

Exclusion Criteria:

  • Having lower extremity discrepancy more than 1 centimeter (cm),
  • Having no ambulation without help.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03363074

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Eastern Mediterranean University
Mersin, Famagusta, Turkey, 99450
Sponsors and Collaborators
Eastern Mediterranean University
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Principal Investigator: Yasin Yurt, PhD Eastern Mediterranean University
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Responsible Party: Cansu Koltak, Research Assistant, Eastern Mediterranean University Identifier: NCT03363074    
Other Study ID Numbers: ETK00-2017-0204
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cansu Koltak, Eastern Mediterranean University:
Low-Level Laser Therapy, Orthotic Insoles
Additional relevant MeSH terms:
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Posterior Tibial Tendon Dysfunction
Foot Diseases
Musculoskeletal Diseases