Plantar FasciitisNCT06055933
Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
An observational study of Plantar Fasciitis, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Type of this study: Prospective randomized controlled study. Purpose: The aim of this study is to compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock Therapy (ESWT). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Plantar Fasciitis
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 4 Dec 2023
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers with a diagnosis of plantar fasciitis and meeting inclusion criteria
Who may be able to join
- Adult cases aged 18-65 years diagnosed with plantar fasciitis by a physical medicine and rehabilitation specialist,
- Cases willing to continue the study,
- In the anamnesis, cases with severe pain when taking the first step after waking up in the morning or after a long period of inactivity and progressive aggravation of the pain as the activity continues,
- Cases whose consent forms were obtained by being informed about the study.
Who cannot join
- Cases who have undergone foot and ankle surgery,
- Loss or decrease of sensation in the foot and ankle region for various reasons,
- Difficulty in communication that prevents treatment and evaluations from being carried out effectively,
- Pregnancy,
- Presence of local infection,
- Having a widespread or regional tumoral disease,
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- Having circulatory disorders in the lower extremities, bleeding,
- Anticoagulant use,
- Application of other treatment methods such as cold/hot application, exercise, orthosis use, electrotherapy agents,
- Cases with a history of systemic, inflammatory, neurological or vascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Pain Severity and Lower Extremity Functionality in Plantar Fasciitis
Type of this study: Prospective randomized controlled study. Purpose: The aim of this study is to compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock Therapy (ESWT).
To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis who received KT application in addition to ESWT treatment.
Read more
To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving placebo application.
90 volunteers will be included in the study as ESWT (n=30), placebo ESWT (n=30), ESWT and KT (n=30) application groups. How effective is ESWT, ESWT and Kinesiotape versus placebo ESWT acutely in the treatment of plantar fasciitis?
Read the detailed description
Plantar fasciitis is a common disease in athletes and the sedentary population, accompanied by pain and limitation of foot function. Hot-cold tampon application, nonsteroidal anti-inflammatory drug, heel cushion, night splint, plantar fascia and Achilles stretching exercise, kinesio taping (CT), ultrasound, and extracorporeal shock wave therapy are the methods used in the treatment of plantar fasciitis. The aim of this study is to compare the acute effect on pain level, lower extremity functionality and plantar fascia flexibility in patients with plantar fasciitis receiving ESWT, patients with plantar fasciitis receiving Kinesiotape in addition to ESWT, and patients with plantar fasciitis receiving placebo ESWT.
Age (years), height (cm) and body weight (kg) measured with an adult scale with a mechanical height measure, gender, occupation, affected side and dominant side of patients diagnosed with plantar fasciitis will be recorded.
Patients will be divided into three groups: ESWT (Group 1), ESWT and KT (Group 2), and Placebo/Sham (Group 3) application groups. ESWT (BTL-6000SWT, UK); A single session will be applied at 10 Hz frequency, 2.5 Barr energy and 2000 shocks/session.
For KT application, a tape consisting of 96% cotton, 4% lycra, water-resistant, porous and adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session and the tape will be asked to remain for a week. After the first examination of the physical therapy and rehabilitation specialist physician in the placebo/Sham group, the patient will be listened to the sound of the device through the audio device and ESWT application will be applied without the device working.
For clinical follow-up of the patients, visual pain scale (VAS) score, lower extremity functional scale score will be used before and one week after treatment, and plantar fascia flexibility will be evaluated.
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar fasciitis, extracorporeal shock wave therapy, ESWT, placebo ESWT, plantar fascia, Kinesio Taping
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ESWT | To the ESWT group, with the ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shock/session values was applied with a 15 mm head in a single session. Shock waves were applied directly to the most sensitive point detected in the medial of the calcaneus. | |
| Placebo ESWT | The placebo ESWT group was given the ESWT device sound recorded from the external audio device and the application was performed without the ESWT device operating. | |
| ESWT+KT | With ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shocks/session was applied in a single session with a 15 mm head. Shock waves will be applied directly to the most sensitive point detected in the medial calcaneus, then a tape consisting of 96% cotton and 4% lycra, water-resistant, porous and adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session and the tape will be asked to remain for a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
). VAS, with numbers from 0 to 10 on a 10 cm horizontal line; 0 means "no pain"; It was stated to the patients that 10 represented "unbearable pain". The degree of pain was recorded numerically between 0 and 10
Measured: baseline, post treatment (at 1th week)
Secondary outcomes (1)
Lower Extremity Functional Scale
Lower Extremity Functional Scale; It is a scale developed to evaluate individuals' lower extremity functions, skills and activity limitations, translated into Turkish, and its validity and reliability have been established. Scoring is made between 0-80, with higher values indicating better functional level.
Measured: baseline, post treatment (at 1th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start2 Oct 2023
- Primary completion9 Oct 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkadir dağbaşı, Necmettin Erbakan University
- Investigators
- Hanife Doğan, Principal investigator, Necmettin Erbakan Universityabdulkadir dağbaşı, Study chair, Necmettin Erbakan UniversityAynur Başaran, Study chair, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055933
- Sponsor's protocol ID
- ADagbasi001
- Status last verified
- Dec 2024
- First submitted
- 20 Sep 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Pain Severity and Lower Extremity Functionality in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06055933
- Acronym / sponsor ID
- ADagbasi001
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar fasciitis, extracorporeal shock wave therapy, ESWT, placebo ESWT, plantar fascia, Kinesio Taping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 28 Sep 2023 (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.
Type of this study: Prospective randomized controlled study. Purpose: The aim of this study is to compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock Therapy (ESWT).
To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis who received KT application in addition to ESWT treatment.
To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving placebo application.
90 volunteers will be included in the study as ESWT (n=30), placebo ESWT (n=30), ESWT and KT (n=30) application groups. How effective is ESWT, ESWT and Kinesiotape versus placebo ESWT acutely in the treatment of plantar fasciitis?
Detailed description
Plantar fasciitis is a common disease in athletes and the sedentary population, accompanied by pain and limitation of foot function. Hot-cold tampon application, nonsteroidal anti-inflammatory drug, heel cushion, night splint, plantar fascia and Achilles stretching exercise, kinesio taping (CT), ultrasound, and extracorporeal shock wave therapy are the methods used in the treatment of plantar fasciitis. The aim of this study is to compare the acute effect on pain level, lower extremity functionality and plantar fascia flexibility in patients with plantar fasciitis receiving ESWT, patients with plantar fasciitis receiving Kinesiotape in addition to ESWT, and patients with plantar fasciitis receiving placebo ESWT.
Age (years), height (cm) and body weight (kg) measured with an adult scale with a mechanical height measure, gender, occupation, affected side and dominant side of patients diagnosed with plantar fasciitis will be recorded.
Patients will be divided into three groups: ESWT (Group 1), ESWT and KT (Group 2), and Placebo/Sham (Group 3) application groups. ESWT (BTL-6000SWT, UK); A single session will be applied at 10 Hz frequency, 2.5 Barr energy and 2000 shocks/session.
For KT application, a tape consisting of 96% cotton, 4% lycra, water-resistant, porous and adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session and the tape will be asked to remain for a week. After the first examination of the physical therapy and rehabilitation specialist physician in the placebo/Sham group, the patient will be listened to the sound of the device through the audio device and ESWT application will be applied without the device working.
For clinical follow-up of the patients, visual pain scale (VAS) score, lower extremity functional scale score will be used before and one week after treatment, and plantar fascia flexibility will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT | – | –To the ESWT group, with the ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shock/session values was applied with a 15 mm head in a single session. Shock waves were applied directly to the most sensitive point detected in the medial of the calcaneus. |
| Placebo ESWT | – | –The placebo ESWT group was given the ESWT device sound recorded from the external audio device and the application was performed without the ESWT device operating. |
| ESWT+KT | – | –With ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shocks/session was applied in a single session with a 15 mm head. Shock waves will be applied directly to the most sensitive point detected in the medial calcaneus, then a tape consisting of 96% cotton and 4% lycra, water-resistant, porous and adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session and the tape will be asked to remain for a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with a diagnosis of plantar fasciitis and meeting inclusion criteria
Key inclusion criteria (4 listed)
- Adult cases aged 18-65 years diagnosed with plantar fasciitis by a physical medicine and rehabilitation specialist,
- Cases willing to continue the study,
- In the anamnesis, cases with severe pain when taking the first step after waking up in the morning or after a long period of inactivity and progressive aggravation of the pain as the activity continues,
- Cases whose consent forms were obtained by being informed about the study.
Key exclusion criteria (10 listed)
- Cases who have undergone foot and ankle surgery,
- Loss or decrease of sensation in the foot and ankle region for various reasons,
- Difficulty in communication that prevents treatment and evaluations from being carried out effectively,
- Pregnancy,
- Presence of local infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Scale (VAS)
Time frame: baseline, post treatment (at 1th week)
). VAS, with numbers from 0 to 10 on a 10 cm horizontal line; 0 means "no pain"; It was stated to the patients that 10 represented "unbearable pain". The degree of pain was recorded numerically between 0 and 10
1 secondary outcome
Lower Extremity Functional Scale
Time frame: baseline, post treatment (at 1th week)
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 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hanife Doğan principal investigator
Necmettin Erbakan University
abdulkadir dağbaşı study chair
Necmettin Erbakan University
Aynur Başaran study chair
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fasciitis, run by Necmettin Erbakan University 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 4 inclusion and 10 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 27 Dec 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?
Visual Analogue Scale (VAS) (time frame: baseline, post treatment (at 1th week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.