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

• ClinicalTrials.gov Identifier: NCT04637841
• Recruitment Status: Completed
• First Posted: November 20, 2020
• Last Update Posted: January 20, 2022
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Information provided by (Responsible Party): Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Plantar Fascia	Other: Kinesiology Taping Appliying; Other: Myofascial Release Technique Appliying	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 1, 2021
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: May 27, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Turkey

İstanbul Medeniyet City

İstanbul, Turkey

İstanbul Medeniyet University

Istanbul, Turkey

Sponsors and Collaborators

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

More Information

Publications of Results:

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. Review.

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.

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.

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.

• Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• ClinicalTrials.gov Identifier: NCT04637841
• Other Study ID Numbers: 09.2020.948
• First Posted: November 20, 2020
• Last Update Posted: January 20, 2022
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:

stiffness; creep; plantar fascia; diabetes mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases