Heel SpurNCT06067659
Comparison Of The Treatment Effects Of Different Methods In Patients With Calcaneal Spur
A study testing Extracorporeal shock wave therapy, Kinesiology taping and Extracorporeal shock wave therapy+Kinesiology taping in people with Heel Spur, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
Calcaneal spur (heel spur) is one of the most common disorders associated with foot pain. Patients may complain of pain at every step during the day, so it is important to find the most effective treatment method for patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Heel Spur
- What is being tested?
- Extracorporeal shock wave therapy, Kinesiology taping and Extracorporeal shock wave therapy+Kinesiology taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 9 Dec 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of calcaneal spur by the physician
- Be between 30-70 years old
- The patient complains of pain in the heel region
- Appearance of the calcaneal protrusion on the radiographic image
- Not taking any other treatment or medication (NSAI, steroids, other analgesics) until 4 weeks before the start of the study.
- The patient's willingness to participate in the study.
Who cannot join
- Those who received injection therapy to the foot area in the last 3 months (corticosteroids or corticosteroids/anesthetics),
- Those with rheumatic disease, coagulopathy, thrombophlebitis, neoplasia history, systemic inflammatory disease
- Those with a history of outpatient surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Treatment Effects Of Extracorporeal Shockwave Therapy And Kinesiological Banding In Patients With Calcaneal Spur
Calcaneal spur (heel spur) is one of the most common disorders associated with foot pain. Patients may complain of pain at every step during the day, so it is important to find the most effective treatment method for patients. The aim of this study is to compare the therapeutic efficacy of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KB) in patients with calcaneal spurs.
Thirty patients with calcaneal spurs will be included in the study. The gender, age, body weight, height, body mass index, and affected side of the patients will be recorded. Patients will be randomly divided into three treatment groups: ESWT to the first group, KB therapy to the second group, and combined ESWT+KB to the third group. Each group will be treated for five sessions, once a week for five weeks. ESWT 15Hz frequency will be applied as 2.5 Barr energy and 2000 Shock/session. It will be applied with the KB I and fan method and the tape will not be removed for three days after the application. In the pre- and post-treatment evaluations of the patients, heel sensitivity and sensory perception will be evaluated with the Foot structure Foot Posture Index (API). Visual Analog Scale (VAS), Quality of Life Short Form-36 (SF-36), Foot Function Index (AFI) and Windlass Test will be used.
Read the detailed description
One of the most common pathologies that causes foot pain, negatively affects the individual's walking and reduces the quality of life is calcaneal spur (heel spur). Calcaneal spurs are fibro-cartilaginous protrusions varying in size that form around the calcaneal bone, the strongest, most important and rearmost bone in the foot.
Treatment aims to reduce pain, reduce inflation, and shrink and eliminate the spur. Conservative treatment includes exercises, massage, ultrasound, phonophoresis, laser, short wave diathermy, cryotherapy and extracorporeal shock wave therapy (ESWT) as physiotherapy applications.
ESWT are pressure waves delivered to the body to stimulate soft tissue growth through local hyperemia, neovascularization, reduction of calcification, inhibition of pain receptors and denervation to provide pain relief and healing of chronic processes. ESWT is also used effectively in the treatment of calcaneal spur.
The aim of this study is to observe the superiority, if any, of ESWT and KB in the treatment of each other or to show how effective the combined application of the two is in the treatment of calcaneal spur.
This study will be a single-blind, randomized controlled trial to compare the effectiveness of BP and ESWT in patients with calcaneal spurs. All procedures used will be carried out in accordance with the ethical rules of the Declaration of Helsinki and were approved by the Amasya University Clinical Research Ethics Committee (E-30640013-050.01.04-126508). The study will be carried out on patients who applied to the Physical Therapy and Rehabilitation Polyclinic of a hospital between 10.10.2023 and 10.12.2023 with the complaint of heel pain and diagnosed with calcaneal spur.
Inclusion criteria for the study were diagnosis of calcaneal spur by a physician, being in the age range of 30-70 years, patient complaining of pain in the heel region, appearance of calcaneal protrusion in the radiographic image, no other treatment or medication (NSAI). , steroids, other drugs, etc.) analgesics) and the patient volunteered to participate in the study. Exclusion criteria were those who received injection therapy to the foot area (corticosteroids or corticosteroids/anesthetics), those with a history of rheumatic disease, coagulopathy, thrombophlebitis, neoplasia, systemic inflammatory disease, and outpatient surgery in the last 3 months. No other treatment or medication (NSAI, steroids, other analgesics) will be used during the study period.
- Conditions
- Heel Spur
- Being tested
- Extracorporeal shock wave therapy, Kinesiology taping, Extracorporeal shock wave therapy+Kinesiology taping
- Keywords
- Extracorporeal Shock Wave Therapy, Heel Spur, Kinesio Taping
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyOther
Also called GRUP A
ESWT (EMS Swiss DolorClast® Classic) application will be applied to patients in groups 1 and 3 with a frequency of 15 Hz, a 2000 shock wave and an energy density of 2.5 bar. In practice, patients will be asked to lie in the prone position and keep the knee and hip joints in a neutral position. By placing a towel roll under the ankle, the heel will be stabilized to be applied. Using the ultrasound gel as an intermediate, the ESWT device will be applied to the medial part of the calcaneus.
Kinesiology tapingOther
The material used in the taping will be 5 cm wide and 0.5 mm thick Kinesio® Tape. In practice, the patients were placed in the prone position and the ankle would be dorsiflexed at 10 degrees, and the band would be divided into 4 equal parts on the metatarsals of the 1/3 of the foot from the cruis, starting from the calcaneus. Then, taping will be performed from the medial to the lateral of the calcaneus, passing over the area where the pain is intense. Patients will be asked not to remove the applied tape for 3 days.
Extracorporeal shock wave therapy+Kinesiology tapingOther
Patients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Extracorporeal shock wave therapy | Experimental | ESWT (EMS Swiss DolorClast® Classic) application will be applied to patients in groups 1 and 3 with a frequency of 15 Hz, a 2000 shock wave and an energy density of 2.5 bar. In practice, patients will be asked to lie in the prone position and keep the knee and hip joints in a neutral position. By placing a towel roll under the ankle, the heel will be stabilized to be applied. Using the ultrasound gel as an intermediate, the ESWT device will be applied to the medial part of the calcaneus. Receives: Other: Extracorporeal shock wave therapy |
| Group B: Kinesiology taping | Experimental | The material used in the taping will be 5 cm wide and 0.5 mm thick Kinesio® Tape. In practice, the patients were placed in the prone position and the ankle would be dorsiflexed at 10 degrees, and the band would be divided into 4 equal parts on the metatarsals of the 1/3 of the foot from the cruis, starting from the calcaneus. Then, taping will be performed from the medial to the lateral of the calcaneus, passing over the area where the pain is intense. Patients will be asked not to remove the applied tape for 3 days. Receives: Other: Kinesiology taping |
| Group C: Extracorporeal shock wave therapy+Kinesiology taping | Experimental | Patients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape. Receives: Other: Extracorporeal shock wave therapy; Other: Kinesiology taping; Other: Extracorporeal shock wave therapy+Kinesiology taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a subjective evaluation method that converts some values that cannot be measured numerically into numbers. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line (no pain at all, I have excruciating pain) and the patient will be asked to indicate where on this line their situation is appropriate by drawing a line or pointing or pointing.
Measured: Day 1 and 5 weeks later
Foot Function Index
It is a self-filled form developed to measure the effects of foot pathologies on pain, disability and activity limitation. Foot function index; It consists of 23 items with 3 subgroups as pain, disability and activity limitation. A higher score indicates more pain, disability, and activity limitation.
Measured: Day 1 and 5 weeks later
Secondary outcomes (3)
Sociodemographic information
Participants' age will be recorded in years, height in centimeters, body weight in kilograms, gender in male and female, and affected side in left and right.
Measured: Day 1 and 5 weeks later
Quality of Life Short Form-36
It is a thirty-six-question questionnaire that asks questions about the quality of daily life and the general health of the person, including how he or she has been feeling lately. SF-36 consists of 36 items assessing nine subscales. Evaluation: Each of the 36 items is given a score between 0 and 100, depending on the answers. The higher the score, the better the quality of life It means at a high level.
Measured: Day 1 and 5 weeks later
Windlass Test
The plantar fascia is stretched when a load is present on the sole of the foot. The medial longitudinal arch is stretched to create more than 20 degrees of extension in the tarsal bones, and with it, a tensile force occurs in the plantar fascia. It is aimed to further stretch the fascia by extending the toes while the sole of the foot is in contact and the plantar fascia is taut. On physical examination, there is tenderness with finger pressure around the medial calcaneal tubercle, which is the attachment point of the plantar fascia to the calcaneus. When the thumb is forced into dorsiflexion, the plantar fascia will be stretched, causing pain at the attachment point of the fascia to the calcaneus. This is known as the windlass test.
Measured: Day 1 and 5 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 Jun 2023
- Primary completion20 Nov 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Factorial Assignment randomized controlled trial 3 groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
- Investigators
- Yasemin şAHBAZ, Study director, İstanbul Beykent Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067659
- Sponsor's protocol ID
- UBeykent-5
- Status last verified
- Dec 2023
- First submitted
- 4 Sep 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Treatment Effects Of Extracorporeal Shockwave Therapy And Kinesiological Banding In Patients With Calcaneal Spur
- ClinicalTrials.gov ID
- NCT06067659
- Acronym / sponsor ID
- UBeykent-5
- Conditions
- Heel Spur
- Keywords
- Extracorporeal Shock Wave Therapy, Heel Spur, Kinesio Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 5 Oct 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.
Calcaneal spur (heel spur) is one of the most common disorders associated with foot pain. Patients may complain of pain at every step during the day, so it is important to find the most effective treatment method for patients. The aim of this study is to compare the therapeutic efficacy of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KB) in patients with calcaneal spurs.
Thirty patients with calcaneal spurs will be included in the study. The gender, age, body weight, height, body mass index, and affected side of the patients will be recorded. Patients will be randomly divided into three treatment groups: ESWT to the first group, KB therapy to the second group, and combined ESWT+KB to the third group. Each group will be treated for five sessions, once a week for five weeks. ESWT 15Hz frequency will be applied as 2.5 Barr energy and 2000 Shock/session. It will be applied with the KB I and fan method and the tape will not be removed for three days after the application. In the pre- and post-treatment evaluations of the patients, heel sensitivity and sensory perception will be evaluated with the Foot structure Foot Posture Index (API). Visual Analog Scale (VAS), Quality of Life Short Form-36 (SF-36), Foot Function Index (AFI) and Windlass Test will be used.
Detailed description
One of the most common pathologies that causes foot pain, negatively affects the individual's walking and reduces the quality of life is calcaneal spur (heel spur). Calcaneal spurs are fibro-cartilaginous protrusions varying in size that form around the calcaneal bone, the strongest, most important and rearmost bone in the foot.
Treatment aims to reduce pain, reduce inflation, and shrink and eliminate the spur. Conservative treatment includes exercises, massage, ultrasound, phonophoresis, laser, short wave diathermy, cryotherapy and extracorporeal shock wave therapy (ESWT) as physiotherapy applications.
ESWT are pressure waves delivered to the body to stimulate soft tissue growth through local hyperemia, neovascularization, reduction of calcification, inhibition of pain receptors and denervation to provide pain relief and healing of chronic processes. ESWT is also used effectively in the treatment of calcaneal spur.
The aim of this study is to observe the superiority, if any, of ESWT and KB in the treatment of each other or to show how effective the combined application of the two is in the treatment of calcaneal spur.
This study will be a single-blind, randomized controlled trial to compare the effectiveness of BP and ESWT in patients with calcaneal spurs. All procedures used will be carried out in accordance with the ethical rules of the Declaration of Helsinki and were approved by the Amasya University Clinical Research Ethics Committee (E-30640013-050.01.04-126508). The study will be carried out on patients who applied to the Physical Therapy and Rehabilitation Polyclinic of a hospital between 10.10.2023 and 10.12.2023 with the complaint of heel pain and diagnosed with calcaneal spur.
Inclusion criteria for the study were diagnosis of calcaneal spur by a physician, being in the age range of 30-70 years, patient complaining of pain in the heel region, appearance of calcaneal protrusion in the radiographic image, no other treatment or medication (NSAI). , steroids, other drugs, etc.) analgesics) and the patient volunteered to participate in the study. Exclusion criteria were those who received injection therapy to the foot area (corticosteroids or corticosteroids/anesthetics), those with a history of rheumatic disease, coagulopathy, thrombophlebitis, neoplasia, systemic inflammatory disease, and outpatient surgery in the last 3 months. No other treatment or medication (NSAI, steroids, other analgesics) will be used during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Crossover Assignment Factorial Assignment randomized controlled trial 3 groups
| Arm | Type | Receives |
|---|---|---|
| Group A: Extracorporeal shock wave therapy | Experimental | Other: Extracorporeal shock wave therapyESWT (EMS Swiss DolorClast® Classic) application will be applied to patients in groups 1 and 3 with a frequency of 15 Hz, a 2000 shock wave and an energy density of 2.5 bar. In practice, patients will be asked to lie in the prone position and keep the knee and hip joints in a neutral position. By placing a towel roll under the ankle, the heel will be stabilized to be applied. Using the ultrasound gel as an intermediate, the ESWT device will be applied to the medial part of the calcaneus. |
| Group B: Kinesiology taping | Experimental | Other: Kinesiology tapingThe material used in the taping will be 5 cm wide and 0.5 mm thick Kinesio® Tape. In practice, the patients were placed in the prone position and the ankle would be dorsiflexed at 10 degrees, and the band would be divided into 4 equal parts on the metatarsals of the 1/3 of the foot from the cruis, starting from the calcaneus. Then, taping will be performed from the medial to the lateral of the calcaneus, passing over the area where the pain is intense. Patients will be asked not to remove the applied tape for 3 days. |
| Group C: Extracorporeal shock wave therapy+Kinesiology taping | Experimental | Other: Extracorporeal shock wave therapy, Other: Kinesiology taping, Other: Extracorporeal shock wave therapy+Kinesiology tapingPatients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of calcaneal spur by the physician
- Be between 30-70 years old
- The patient complains of pain in the heel region
- Appearance of the calcaneal protrusion on the radiographic image
- Not taking any other treatment or medication (NSAI, steroids, other analgesics) until 4 weeks before the start of the study.
Key exclusion criteria (3 listed)
- Those who received injection therapy to the foot area in the last 3 months (corticosteroids or corticosteroids/anesthetics),
- Those with rheumatic disease, coagulopathy, thrombophlebitis, neoplasia history, systemic inflammatory disease
- Those with a history of outpatient surgery
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 |
|---|---|---|
| Extracorporeal shock wave therapyAlso: GRUP AESWT (EMS Swiss DolorClast® Classic) application will be applied to patients in groups 1 and 3 with a frequency of 15 Hz, a 2000 shock wave and an energy density of 2.5 bar. In practice, patients will be asked to lie in the prone position and keep the knee and hip joints in a neutral position. By placing a towel roll under the ankle, the heel will be stabilized to be applied. Using the ultrasound gel as an intermediate, the ESWT device will be applied to the medial part of the calcaneus. | Other | Group A: Extracorporeal shock wave therapy, Group C: Extracorporeal shock wave therapy+Kinesiology taping |
| Kinesiology tapingThe material used in the taping will be 5 cm wide and 0.5 mm thick Kinesio® Tape. In practice, the patients were placed in the prone position and the ankle would be dorsiflexed at 10 degrees, and the band would be divided into 4 equal parts on the metatarsals of the 1/3 of the foot from the cruis, starting from the calcaneus. Then, taping will be performed from the medial to the lateral of the calcaneus, passing over the area where the pain is intense. Patients will be asked not to remove the applied tape for 3 days. | Other | Group B: Kinesiology taping, Group C: Extracorporeal shock wave therapy+Kinesiology taping |
| Extracorporeal shock wave therapy+Kinesiology tapingPatients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape. | Other | Group C: Extracorporeal shock wave therapy+Kinesiology taping |
Primary outcome
Visual Analog Scale
Time frame: Day 1 and 5 weeks later
It is a subjective evaluation method that converts some values that cannot be measured numerically into numbers. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line (no pain at all, I have excruciating pain) and the patient will be asked to indicate where on this line their situation is appropriate by drawing a line or pointing or pointing.
Foot Function Index
Time frame: Day 1 and 5 weeks later
It is a self-filled form developed to measure the effects of foot pathologies on pain, disability and activity limitation. Foot function index; It consists of 23 items with 3 subgroups as pain, disability and activity limitation. A higher score indicates more pain, disability, and activity limitation.
3 secondary outcomes
Sociodemographic information
Time frame: Day 1 and 5 weeks later
Quality of Life Short Form-36
Time frame: Day 1 and 5 weeks later
Windlass Test
Time frame: Day 1 and 5 weeks later
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 18 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Yasemin şAHBAZ study director
İstanbul Beykent Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy, Kinesiology taping and Extracorporeal shock wave therapy+Kinesiology taping in people with Heel Spur, run by University of Beykent 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 6 inclusion and 3 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 18 Dec 2023. 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 Analog Scale (time frame: Day 1 and 5 weeks later). The study lists 2 primary outcomes in all. 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 18 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.