Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping
1 other identifier
interventional
26
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Feb 2021
Shorter than P25 for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2021
CompletedNovember 29, 2023
November 1, 2023
3 months
November 8, 2020
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
Evaluation of range of motion of ankle
Change from baseline range of motion at following kinesiologic tape appliying and at 30min.
Evaluation of foot sole pain
Change from baseline foot sole pain at following kinesiologic tape appliying and at 30min.
Evaluation of skin temperature
Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.
Study Arms (4)
Diabetes Mellitus Kinesiology Taping Group
ACTIVE COMPARATORKinesiology tape will be applied to the left foot of the participants in diabetes mellitus group.
Kinesiology Taping Control Group
ACTIVE COMPARATORKinesiology tape will be applied to the left foot of the healthy participants in the control group.
Diabetes Mellitus Myofascial Release Group
ACTIVE COMPARATORMyofascial Release Technique will be applied to the right foot of the participants in diabetes mellitus group.
Myofascial Release Control Group
ACTIVE COMPARATORMyofascial Release Technique taping will be applied to the right foot of the healthy participants in the control group.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
İstanbul Medeniyet City
Istanbul, Turkey (Türkiye)
İstanbul Medeniyet University
Istanbul, Turkey (Türkiye)
Related 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.
PMID: 24703512RESULTAmerican 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.
PMID: 30559242RESULTBernard 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.
PMID: 23084004RESULTChen 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.
PMID: 31908942RESULTHicks 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.
PMID: 11427329RESULTKong 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.
PMID: 30479528RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2020
First Posted
November 20, 2020
Study Start
February 1, 2021
Primary Completion
May 3, 2021
Study Completion
May 27, 2021
Last Updated
November 29, 2023
Record last verified: 2023-11