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

NCT06067659 | Completed

• 1 other identifier: UBeykent-5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heel Spur

Keywords

Extracorporeal Shock Wave Therapy; Heel Spur; Kinesio Taping

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1 and 5 weeks later

Secondary Outcomes (3)

• Sociodemographic information

  Day 1 and 5 weeks later

• Quality of Life Short Form-36

  Day 1 and 5 weeks later

• Windlass Test

  Day 1 and 5 weeks later

Study Arms (3)

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.

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.

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.

Other: Extracorporeal shock wave therapy; Other: Kinesiology taping; Other: Extracorporeal shock wave therapy+Kinesiology taping

Interventions

Extracorporeal shock wave therapy OTHER

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.

Also known as: GRUP A

Group A: Extracorporeal shock wave therapy; Group C: Extracorporeal shock wave therapy+Kinesiology taping

Kinesiology taping OTHER

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.

Group B: Kinesiology taping; Group C: Extracorporeal shock wave therapy+Kinesiology taping

Extracorporeal shock wave therapy+Kinesiology taping OTHER

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

Group C: Extracorporeal shock wave therapy+Kinesiology taping

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Yasemin ŞAHBAZ

Beyli̇kdüzü, Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heel Spur

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yasemin şAHBAZ

  İstanbul Beykent Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Crossover Assignment Factorial Assignment randomized controlled trial 3 groups

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 5, 2023
• Study Start: June 20, 2023
• Primary Completion: November 20, 2023
• Study Completion: December 9, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)