Clinical trial NCT06067659: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heel Spur
Keywords: Extracorporeal Shock Wave Therapy
Heel Spur
Kinesio Taping
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Factorial Assignment randomized controlled trial 3 groups
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Day 1 and 5 weeks later
measure: Foot Function Index
timeFrame: Day 1 and 5 weeks later
Secondary outcomes:
measure: Sociodemographic information
timeFrame: Day 1 and 5 weeks later
measure: Quality of Life Short Form-36
timeFrame: Day 1 and 5 weeks later
measure: Windlass Test
timeFrame: Day 1 and 5 weeks later
Other outcomes:
Locations:
city: Beyli̇kdüzü
country: Turkey
facility: Yasemin ŞAHBAZ
state: İstanbul
Study officials:
affiliation: İstanbul Beykent Üniversitesi
name: Yasemin şAHBAZ
role: STUDY_DIRECTOR
References: