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

NCT03363074 | Completed DMC

• 1 other identifier: ETK00-2017-0204
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Tibial Tendon Insufficiency

Keywords

Low-Level Laser Therapy, Orthotic Insoles

Outcome Measures

Primary Outcomes (1)

• Change in Foot Function Assesed With Foot Function Index

  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

  Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group

Secondary Outcomes (2)

• Change in Muscle Strength Assesed With Humac Norm Isocynetic Dynanometer

  Basline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group

• Change in Foot Pain Assesed With Digital Algometer

  Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group

Study Arms (2)

Orthotic Insole

EXPERIMENTAL

Device: Orthotic Insole 8-week follow-up with Orthotic Insole

Device: Orthotic Insole

Low-level Laser Therapy

EXPERIMENTAL

Low-Level Laser 5-week follow-up

Device: Low-Level Laser

Interventions

Orthotic Insole DEVICE

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.

Orthotic Insole

Low-Level Laser DEVICE

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.

Low-level Laser Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, Famagusta, 99450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction

Interventions

Foot Orthoses; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Yasin Yurt, PhD

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: November 20, 2017
• Primary Completion: August 25, 2018
• Study Completion: September 5, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)