Diabetes MellitusNCT04637841
Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping
A study testing Kinesiology Taping Appliying and Myofascial Release Technique Appliying in people with Diabetes Mellitus and Plantar Fascia, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Plantar Fascia
- What is being tested?
- Kinesiology Taping Appliying and Myofascial Release Technique Appliying
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 27 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Medeniyet City
Istanbul
İstanbul Medeniyet University
Istanbul
About this study
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
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.
- Conditions
- Diabetes Mellitus, Plantar Fascia
- Being tested
- Kinesiology Taping Appliying, Myofascial Release Technique Appliying
- Keywords
- stiffness, creep, plantar fascia, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology Taping AppliyingOther
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 AppliyingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus Kinesiology Taping Group | Active comparator | Kinesiology tape will be applied to the left foot of the participants in diabetes mellitus group. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Myofascial Release Technique Appliying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of foot plantar pressure distribution
Plantar pressure distrubution (gr/ cm²) on the force platform will be measured.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Range of motion of ankle was measured with goniometer
Measured: 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).
Measured: 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)
Measured: Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Feb 2021
- Primary completion3 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637841
- Sponsor's protocol ID
- 09.2020.948
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24703512American 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.
PubMed 30559242Bernard 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.
PubMed 23084004Chen 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.
PubMed 31908942Hicks 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.
PubMed 11427329Kong 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.
PubMed 30479528
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04637841
- Acronym / sponsor ID
- 09.2020.948
- Conditions
- Diabetes Mellitus, Plantar Fascia
- Keywords
- stiffness, creep, plantar fascia, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus Kinesiology Taping Group | Active comparator | Other: Kinesiology Taping AppliyingKinesiology tape will be applied to the left foot of the participants in diabetes mellitus group. |
| Kinesiology Taping Control Group | Active comparator | Other: Kinesiology Taping AppliyingKinesiology tape will be applied to the left foot of the healthy participants in the control group. |
| Diabetes Mellitus Myofascial Release Group | Active comparator | Other: Myofascial Release Technique AppliyingMyofascial Release Technique will be applied to the right foot of the participants in diabetes mellitus group. |
| Myofascial Release Control Group | Active comparator | Other: Myofascial Release Technique AppliyingMyofascial Release Technique taping will be applied to the right foot of the healthy participants in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiology Taping AppliyingKinesiology 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. | Other | Diabetes Mellitus Kinesiology Taping Group, Kinesiology Taping Control Group |
| Myofascial Release Technique AppliyingMyofascial 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. | Other | Diabetes Mellitus Myofascial Release Group, Myofascial Release Control Group |
Primary outcome
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.
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).
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).
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).
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).
3 secondary outcomes
Evaluation of range of motion of ankle
Time frame: Change from baseline range of motion at following kinesiologic tape appliying and at 30min.
Evaluation of foot sole pain
Time frame: Change from baseline foot sole pain at following kinesiologic tape appliying and at 30min.
Evaluation of skin temperature
Time frame: Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Results publication: PubMed 24703512Ajimsha 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.
- Results publication: PubMed 30559242American 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.
- Results publication: PubMed 23084004Bernard 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.
- Results publication: PubMed 31908942Chen 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.
- Results publication: PubMed 11427329Hicks 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.
- Results publication: PubMed 30479528Kong 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.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology Taping Appliying and Myofascial Release Technique Appliying in people with Diabetes Mellitus and Plantar Fascia, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of foot plantar pressure distribution (time frame: Change from baseline plantar presure distrubution at following kinesiologic tape appliying and at 30min.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637841, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.