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Comparison Of The Treatment Effects Of Different Methods In Patients With Calcaneal Spur

Primary Purpose

Heel Spur

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Kinesiology taping
Extracorporeal shock wave therapy+Kinesiology taping
Sponsored by
University of Beykent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heel Spur focused on measuring Extracorporeal Shock Wave Therapy, Heel Spur, Kinesio Taping

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Yasemin ŞAHBAZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A: Extracorporeal shock wave therapy

Group B: Kinesiology taping

Group C: Extracorporeal shock wave therapy+Kinesiology taping

Arm Description

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.

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.

Patients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 4, 2023
Last Updated
October 2, 2023
Sponsor
University of Beykent
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1. Study Identification

Unique Protocol Identification Number
NCT06067659
Brief Title
Comparison Of The Treatment Effects Of Different Methods In Patients With Calcaneal Spur
Official Title
Comparison Of The Treatment Effects Of Extracorporeal Shockwave Therapy And Kinesiological Banding In Patients With Calcaneal Spur
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Beykent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heel Spur
Keywords
Extracorporeal Shock Wave Therapy, Heel Spur, Kinesio Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment Factorial Assignment randomized controlled trial 3 groups
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Extracorporeal shock wave therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: Kinesiology taping
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C: Extracorporeal shock wave therapy+Kinesiology taping
Arm Type
Experimental
Arm Description
Patients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape.
Intervention Type
Other
Intervention Name(s)
Extracorporeal shock wave therapy
Other Intervention Name(s)
GRUP A
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiology taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Extracorporeal shock wave therapy+Kinesiology taping
Intervention Description
Patients in this group will be treated with both extracorporeal shock wave therapy and kinesiotape.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Day 1 and 5 weeks later
Title
Foot Function Index
Description
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.
Time Frame
Day 1 and 5 weeks later
Secondary Outcome Measure Information:
Title
Sociodemographic information
Description
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.
Time Frame
Day 1 and 5 weeks later
Title
Quality of Life Short Form-36
Description
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.
Time Frame
Day 1 and 5 weeks later
Title
Windlass Test
Description
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.
Time Frame
Day 1 and 5 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin şAHBAZ
Phone
05455649695
Email
fztyaseminsahbaz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin şAHBAZ
Phone
05455649695
Email
yaseminsahbaz@beykent.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin şAHBAZ
Organizational Affiliation
İstanbul Beykent Üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Yasemin ŞAHBAZ
City
Beyli̇kdüzü
State/Province
İstanbul
ZIP/Postal Code
34500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin ŞAHBAZ
Phone
05455649695
Email
yaseminsahbaz@beykent.edu.tr
First Name & Middle Initial & Last Name & Degree
Yasemin ŞAHBAZ
Phone
05455649695
Email
fztyaseminsahbaz@gmail.com
First Name & Middle Initial & Last Name & Degree
Eylem Küçük
First Name & Middle Initial & Last Name & Degree
Sema Gül
First Name & Middle Initial & Last Name & Degree
Tuğçe Şahin
First Name & Middle Initial & Last Name & Degree
Yeşim Sarı
First Name & Middle Initial & Last Name & Degree
Cansu Yılmaz
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Tiryaki

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Of The Treatment Effects Of Different Methods In Patients With Calcaneal Spur

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