NCT04637841

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 8, 2020

Last Update Submit

November 28, 2023

Conditions

Keywords

stiffnesscreepplantar fasciadiabetes mellitus

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 COMPARATOR

Kinesiology tape will be applied to the left foot of the participants in diabetes mellitus group.

Other: Kinesiology Taping Appliying

Kinesiology Taping Control Group

ACTIVE COMPARATOR

Kinesiology tape will be applied to the left foot of the healthy participants in the control group.

Other: Kinesiology Taping Appliying

Diabetes Mellitus Myofascial Release Group

ACTIVE COMPARATOR

Myofascial Release Technique will be applied to the right foot of the participants in diabetes mellitus group.

Other: Myofascial Release Technique Appliying

Myofascial Release Control Group

ACTIVE COMPARATOR

Myofascial Release Technique taping will be applied to the right foot of the healthy participants in the control group.

Other: Myofascial Release Technique Appliying

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.

Diabetes Mellitus Kinesiology Taping GroupKinesiology Taping Control Group

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.

Diabetes Mellitus Myofascial Release GroupMyofascial Release Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

Locations