Calcaneal SpurNCT06533683
Effects of Kinesio Taping and Extracorporeal Shock Wave Therapy in the Calcaneal Spur
An observational study of Calcaneal Spur and Plantar Fasciitis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The term \"heel pain\" is used to describe a common, painful condition that is localized in the plantar part of the heel and worsens when weight is placed on the heel. Patients with heel pain are more likely to have thickened plantar fascia, abnormal plantar fascia tissue, thicker plantar heel fat pad, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calcaneal Spur, Plantar Fasciitis, Heel Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 2024
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Şişli Hamidiye Etfal Training and Research Hospital with complaints of heel pain were evaluated. The data of patients who underwent ESWT and kinesio taping were compared with the information on the hospital system.
Who may be able to join
- Aged 18 years and over with heel pain
- A calcaneal spur seen on foot radiographs
Who cannot join
- Those who had received a steroid injection into the heel within the past three months
- Those who had experienced trauma or surgery to the foot and ankle within the past six months
- Those with a rheumatic disease affecting the foot and ankle (e.g., spondyloarthritis)
- Those with open wounds or infections in the area to be treated with lesions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: Effects of Kinesio Taping Versus Extracorporeal Shock Wave Therapy on Pain in the Treatment of Calcaneal Spur: A Retrospective Clinical Study
The term \"heel pain\" is used to describe a common, painful condition that is localized in the plantar part of the heel and worsens when weight is placed on the heel. Patients with heel pain are more likely to have thickened plantar fascia, abnormal plantar fascia tissue, thicker plantar heel fat pad, and calcaneal spur. Calcaneal spurs are bony protrusions that typically occur just in front of the medial calcaneal tuberosity. Systemic medical treatments, physical therapy agents, exercise and local injections are often applied for heel pain caused by plantar fasciitis and calcaneal spur.
This study is to examine the effects of ESWT and kinesio taping on pain and other clinical outcomes in patients with calcaneal spurs.
Read the detailed description
The responses of patients who underwent ESWT or kinesio taping due to calcaneal spur before and after treatment will be compared. Pain, functionality and quality of life are the clinical parameters compared.
- Conditions
- Calcaneal Spur, Plantar Fasciitis, Heel Pain
- Keywords
- calcaneal spur, extracorporeal shock wave therapy, kinesio taping, plantar fasciitis
- Medical subject headings
- Heel Spur, 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 |
|---|---|---|
| Group 1 : ESWT treatment group | ESWT treatment is applied once a week for 5 weeks | |
| Group 2 : Kinesio taping treatment group | Kinesio taping was also applied once a week, for a total of 5 sessions. The rake method was used for kinesio taping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level before treatment and 3rd month after treatment
Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)
Measured: From enrollment to the end of treatment at 3rd month
Secondary outcomes (3)
Assessment of heel sensitivity
It will be evaluated with the Heel Tenderness index. (0=no pain; 1=painful; 2=painful and whines; 3=painful, whines, and withdraws)
Measured: From enrollment to the end of treatment at 3rd month
Assessment of functionality
Foot Function Index was used. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability, and activity limitation in patients. Pain, disability, and activity limitation subscale scores range from 0 to 100.
Measured: From enrollment to the end of treatment at 3rd month
Assessment of quality of life
The 12-item short-form health survey (SF-12) quality of life scale was used to evaluate general quality of life. It was presented as a physical component score (PCS) and mental component score (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: From enrollment to the end of treatment at 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneal SpurStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Banu Kuran, Professor, Study director, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533683
- Sponsor's protocol ID
- 26.09.2023 / 4096
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping Versus Extracorporeal Shock Wave Therapy on Pain in the Treatment of Calcaneal Spur: A Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT06533683
- Acronym / sponsor ID
- 26.09.2023 / 4096
- Conditions
- Calcaneal Spur, Plantar Fasciitis, Heel Pain
- Keywords
- calcaneal spur, extracorporeal shock wave therapy, kinesio taping, plantar fasciitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Aug 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.
The term \"heel pain\" is used to describe a common, painful condition that is localized in the plantar part of the heel and worsens when weight is placed on the heel. Patients with heel pain are more likely to have thickened plantar fascia, abnormal plantar fascia tissue, thicker plantar heel fat pad, and calcaneal spur. Calcaneal spurs are bony protrusions that typically occur just in front of the medial calcaneal tuberosity. Systemic medical treatments, physical therapy agents, exercise and local injections are often applied for heel pain caused by plantar fasciitis and calcaneal spur.
This study is to examine the effects of ESWT and kinesio taping on pain and other clinical outcomes in patients with calcaneal spurs.
Detailed description
The responses of patients who underwent ESWT or kinesio taping due to calcaneal spur before and after treatment will be compared. Pain, functionality and quality of life are the clinical parameters compared.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : ESWT treatment group | – | –ESWT treatment is applied once a week for 5 weeks |
| Group 2 : Kinesio taping treatment group | – | –Kinesio taping was also applied once a week, for a total of 5 sessions. The rake method was used for kinesio taping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Şişli Hamidiye Etfal Training and Research Hospital with complaints of heel pain were evaluated. The data of patients who underwent ESWT and kinesio taping were compared with the information on the hospital system.
Key inclusion criteria (2 listed)
- Aged 18 years and over with heel pain
- A calcaneal spur seen on foot radiographs
Key exclusion criteria (4 listed)
- Those who had received a steroid injection into the heel within the past three months
- Those who had experienced trauma or surgery to the foot and ankle within the past six months
- Those with a rheumatic disease affecting the foot and ankle (e.g., spondyloarthritis)
- Those with open wounds or infections in the area to be treated with lesions.
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
Pain level before treatment and 3rd month after treatment
Time frame: From enrollment to the end of treatment at 3rd month
Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)
3 secondary outcomes
Assessment of heel sensitivity
Time frame: From enrollment to the end of treatment at 3rd month
Assessment of functionality
Time frame: From enrollment to the end of treatment at 3rd month
Assessment of quality of life
Time frame: From enrollment to the end of treatment at 3rd month
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 1 Aug 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.
Banu Kuran, Professor study director
Şişli Hamidiye Etfal Training and Research Hospital
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 Calcaneal Spur and Plantar Fasciitis, run by Sisli Hamidiye Etfal Training and Research Hospital 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 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 1 Aug 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?
Pain level before treatment and 3rd month after treatment (time frame: From enrollment to the end of treatment at 3rd month). 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 1 Aug 2024.