Plantar FascitisNCT06516393
Kinesio Tape Application in the Treatment of Plantar Fasciitis
A study testing The radial shock wave device in people with Plantar Fascitis, run by Bihter Aslanyurek at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- The radial shock wave device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2023to 30 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of unilateral plantar fasciitis,
- The presence of a heel spur on a lateral radiograph
Who cannot join
- Lower extremity surgeries or traumas,
- Systemic inflammatory disease,
- Steroid injections administered within the past six months,
- Pacemaker usage,
- Coagulation disorders,
- Use of anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Kinesio Tape Negatively Affect the Treatment by Creating a Hard Floor in Plantar Fasciitis Treatment: A Randomized Clinical Trial
This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.
Read the detailed description
The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment.
- Conditions
- Plantar Fascitis
- Being tested
- The radial shock wave device
- Keywords
- Plantar Fasciitis, Radial Extracorporeal Shock Wave Therapy, Kinesio Taping, Pain
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The radial shock wave deviceDevice
Also called The r-ESWT+Kinesio taping (KT)
The r-ESWT+Kinesio Tape Application
| Study group | Role | What they receive |
|---|---|---|
| Radial extracorporeal shock wave therapy (r-ESWT) application group | Experimental | Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Receives: Device: The radial shock wave device |
| r-ESWT + Kinesio taping (KT) application group | Active comparator | Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Receives: Device: The radial shock wave device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the Visual Analog Scale (VAS) at week 5
VAS is a tool where patients indicate the level of pain they feel using a 10 cm ruler. VAS pain score "no pain" (score=0) and "worst pain" (score=10).
Measured: Baseline and week 5
Change from baseline Foot function via the Foot Function Index (FFI) at week 5
FFI is a safe and valid foot-specific assessment measure used to evaluate pain, disability, and activity limitation, filled out by the patient self-reported
Measured: Baseline and week 5
Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5
The patient was seated on a flat surface with the knees extended and the soles of the feet touching the wall. The tests were repeated three times and the average of the three measurements was taken.
Measured: Baseline and week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start13 Sep 2023
- Primary completion18 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- the patients were divided into subgroups by the sports physician according to age, height, body weight and body mass index. Patients with similar characteristics were randomized to one of two groups.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bihter Aslanyurek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516393
- Sponsor's protocol ID
- GEAH
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared
Publications
Kocahan T, Orscelik A, Gunaydin H, Buyukluoglu G, Karaaslan B, Asar E, Akinoglu B. Can kinesio tape negatively affect the treatment by creating a hard floor in plantar fasciitis treatment? A randomized clinical trial. PLoS One. 2025 May 5;20(5):e0322397. doi: 10.1371/journal.pone.0322397. eCollection 2025.
PubMed 40323967
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Kinesio Tape Negatively Affect the Treatment by Creating a Hard Floor in Plantar Fasciitis Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06516393
- Acronym / sponsor ID
- GEAH
- Conditions
- Plantar Fascitis
- Keywords
- Plantar Fasciitis, Radial Extracorporeal Shock Wave Therapy, Kinesio Taping, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bihter AslanyurekUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Jul 2024 (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.
This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.
Detailed description
The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the patients were divided into subgroups by the sports physician according to age, height, body weight and body mass index. Patients with similar characteristics were randomized to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Radial extracorporeal shock wave therapy (r-ESWT) application group | Experimental | Device: The radial shock wave devicePatients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. |
| r-ESWT + Kinesio taping (KT) application group | Active comparator | Device: The radial shock wave devicePatients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of unilateral plantar fasciitis,
- The presence of a heel spur on a lateral radiograph
Key exclusion criteria (6 listed)
- Lower extremity surgeries or traumas,
- Systemic inflammatory disease,
- Steroid injections administered within the past six months,
- Pacemaker usage,
- Coagulation disorders,
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 |
|---|---|---|
| The radial shock wave deviceAlso: The r-ESWT+Kinesio taping (KT)The r-ESWT+Kinesio Tape Application | Device | Radial extracorporeal shock wave therapy (r-ESWT) application group, r-ESWT + Kinesio taping (KT) application group |
Primary outcome
Change from baseline in pain on the Visual Analog Scale (VAS) at week 5
Time frame: Baseline and week 5
VAS is a tool where patients indicate the level of pain they feel using a 10 cm ruler. VAS pain score "no pain" (score=0) and "worst pain" (score=10).
Change from baseline Foot function via the Foot Function Index (FFI) at week 5
Time frame: Baseline and week 5
FFI is a safe and valid foot-specific assessment measure used to evaluate pain, disability, and activity limitation, filled out by the patient self-reported
Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5
Time frame: Baseline and week 5
The patient was seated on a flat surface with the knees extended and the soles of the feet touching the wall. The tests were repeated three times and the average of the three measurements was taken.
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 24 Jul 2024.
- Derived from this study: PubMed 40323967Kocahan T, Orscelik A, Gunaydin H, Buyukluoglu G, Karaaslan B, Asar E, Akinoglu B. Can kinesio tape negatively affect the treatment by creating a hard floor in plantar fasciitis treatment? A randomized clinical trial. PLoS One. 2025 May 5;20(5):e0322397. doi: 10.1371/journal.pone.0322397. eCollection 2025.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared
Related trials for Plantar Fascitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The radial shock wave device in people with Plantar Fascitis, run by Bihter Aslanyurek at 1 site 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 2 inclusion and 6 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline in pain on the Visual Analog Scale (VAS) at week 5 (time frame: Baseline and week 5). The study lists 3 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 NCT06516393, which also lists 1 linked publication.
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 24 Jul 2024.