Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping

Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping on Biomechanical and Viscoelastic Properties of Plantar Fascia and Plantar Pressure Distribution in Diabetes Patients

As a result of glycation of collagen fibers in diabetes mellitus, an increase in thickness and stiffness is observed in the plantar fascia, which is a connective tissue. These changes in the plantar fascia affect the windlass mechanism of the foot, normal range of motion and foot plantar pressure distribution. These biomechanical effects may cause the development of diabetic foot ulcers in the later stages of the disease. We hypothesis that myofascial release technique and kinesiology taping methods have an effect on plantar fascia stiffness and plantar pressure distribution in diabetic patients. The aim of this study is to investigate the immediate effects of the two methods on the stiffness of the plantar fascia and foot sole pressure distribution in diabetic patients.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Plantar Fascia
• Intervention / Treatment: Other: Kinesiology Taping Appliying; Other: Myofascial Release Technique Appliying

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Medeniyet University
  • İstanbul, Turkey
    • İstanbul Medeniyet City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Those with diabetic foot ulcer development risk groups 1 and 2 according to the International Working Group on the Diabetic Foot (IWGDF)
• Those who have diabetes for at least 5 years
• Ambulation independently without using an assistive device

Exclusion Criteria:

• Those with foot posture deformity
• Having another disease that will affect connective tissue properties
• Presence of orthopedic or neurological disorders that will affect plantar load distribution
• History of surgery and fractures from the ankle-foot in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diabetes Mellitus Kinesiology Taping Group; Kinesiology tape will be applied to the left foot of the participants in diabetes mellitus group.	Other: Kinesiology Taping Appliying; Kinesiology tape will be applied to left foot plantar fascia of the participants in diabetes mellitus and control group. During taping, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position. A "Palm Shape" taping procedure will be applied to the plantar fascia.
Active Comparator: Kinesiology Taping Control Group; Kinesiology tape will be applied to the left foot of the healthy participants in the control group.	Other: Kinesiology Taping Appliying; Kinesiology tape will be applied to left foot plantar fascia of the participants in diabetes mellitus and control group. During taping, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position. A "Palm Shape" taping procedure will be applied to the plantar fascia.
Active Comparator: Diabetes Mellitus Myofascial Release Group; Myofascial Release Technique will be applied to the right foot of the participants in diabetes mellitus group.	Other: Myofascial Release Technique Appliying; Myofascial release technique will be applied (during 5 minutes) to right foot plantar fascia of the participants in diabetes mellitus and control group During appliying technique, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position.
Active Comparator: Myofascial Release Control Group; Myofascial Release Technique taping will be applied to the right foot of the healthy participants in the control group.	Other: Myofascial Release Technique Appliying; Myofascial release technique will be applied (during 5 minutes) to right foot plantar fascia of the participants in diabetes mellitus and control group During appliying technique, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of foot plantar pressure distribution	Plantar pressure distrubution (gr/ cm²) on the force platform will be measured.	Change from baseline plantar presure distrubution at following kinesiologic tape appliying and at 30min.
Evaluation of stiffness	Stiffness (N/m) of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).	Change from baseline stiffness of the plantar fascia at following kinesiologic tape appliying and at 30min.
Evaluation of decrement	Decrement of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).	Change from baseline decrement properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
Evaluation of creep	Creep of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).	Change from baseline creep properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
Evaluation of relaxation time	Relaxation time of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).	Change from baseline relaxation time properties of the plantar fascia at following kinesiologic tape appliying and at 30min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of range of motion of ankle	Range of motion of ankle was measured with goniometer	Change from baseline range of motion at following kinesiologic tape appliying and at 30min.
Evaluation of foot sole pain	Pain was evaluated by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain).	Change from baseline foot sole pain at following kinesiologic tape appliying and at 30min.
Evaluation of skin temperature	Plantar skin temperature will be measured by thermal imaging machine (Flir Sistem, ThermaCAM, Sweden)	Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.

Collaborators and Investigators

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

General Publications

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
• Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.
• American Diabetes Association. 16. Diabetes Advocacy: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S182-S183. doi: 10.2337/dc19-S016.
• Bernard V, Staffa E, Mornstein V, Bourek A. Infrared camera assessment of skin surface temperature--effect of emissivity. Phys Med. 2013 Nov;29(6):583-91. doi: 10.1016/j.ejmp.2012.09.003. Epub 2012 Oct 18.
• Chen TL, Wong DW, Peng Y, Zhang M. Prediction on the plantar fascia strain offload upon Fascia taping and Low-Dye taping during running. J Orthop Translat. 2019 Aug 7;20:113-121. doi: 10.1016/j.jot.2019.06.006. eCollection 2020 Jan.
• Kong PW, Chua YH, Kawabata M, Burns SF, Cai C. Effect of Post-Exercise Massage on Passive Muscle Stiffness Measured Using Myotonometry - A Double-Blind Study. J Sports Sci Med. 2018 Nov 20;17(4):599-606. eCollection 2018 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: November 8, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: stiffness; diabetes mellitus; plantar fascia; creep
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 09.2020.948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No