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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637841
• Other study ID #: 09.2020.948
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 27, 2021

Study information

• Verified date: November 2023
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 27, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Plantar Fascia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet City	Istanbul
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.