Extracorporeal Shock Wave Therapy Versus High Power LASER Therapy for the Treatment of Females With Calcaneal Spur

NCT06510673 | Not Yet Recruiting

• 1 other identifier: SU1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: To compare the effect of Extracorporeal shock wave therapy and high-power LASER therapy for the treatment of patients with calcaneal spur Background: Calcaneal spur is a common musculoskeletal disorder of the foot that affect the quality-of-life Conservative treatment modalities include, cold application, platelet-rich plasma therapy (PRP), shoe modification, therapeutic ultrasound, extracorporeal shock wave therapy (ESWT), laser therapy (LLLT) are commonly used in the treatment of calcaneal spur. HYPOTHESES: There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on pain intensity in patients with calcaneal spur There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on function in patients with calcaneal spur. There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on the size of calcaneal spur in patients with calcaneal spur. RESEARCH QUESTION: Is there any difference between the effect of Extracorporeal shock wave therapy and High-power LASER on calcaneal spur?

Conditions

Calcaneal Spur

Outcome Measures

Primary Outcomes (3)

• Pain Visual Analog Scale

  It is a self reported outcome which is a 10 cm line with zero at one end indicating no pain and 10 at the other end indicating maximum pain. Patient will be asked to mark the current pain on the scale and the distance from the starting point (0) will be measured

  Baseline and after one month

• foot function index.

  measure the impact of foot pathology on function in terms of pain, disability and activity restriction. it is a self-administered index

  Baseline and after one month

• calcaneal Spur length

  Spur length will be measured by MRI

  Baseline and after one month

Study Arms (4)

Shockwave therapy

EXPERIMENTAL

Shockwave therapy for calcaneal spur

Other: Shockwave therapy

High-power LASER therapy

EXPERIMENTAL

High-power LASER therapy for calcaneal spur

Other: High power LASER

Control

SHAM COMPARATOR

cold application with receive 6 sessions of sham LASER therapy.

Other: Ice application; Other: Sham LASER

Platelet rich plasma

EXPERIMENTAL

Platelet-rich plasma injection for the heel

Drug: Platelet rich plasma

Interventions

Platelet rich plasma DRUG

Platelet-rich plasma for the heel

Platelet rich plasma

High power LASER OTHER

High power LASER sessions for the heel

High-power LASER therapy

Shockwave therapy OTHER

Shockwave therapy sessions for the heel

Shockwave therapy

Ice application OTHER

Ice application for the heel

Control

Sham LASER OTHER

Sham LASER for the heel

Control

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed with calcaneal spur based on clinical examination and radiological findings.

You may not qualify if:

• were as follows: acute trauma to the foot, history of fracture or surgery, lower extremity neurological deficit, polyneuropathy, radicular pain, autoimmune diseases tumor, thrombosis, soft tissue or bone infection, or skin disorder.

Sponsors & Collaborators

• Cairo University: lead
• Suez University: collaborator
• Badr University: collaborator
• Helwan University: collaborator

Study Sites (1)

Badr University in Cairo (BUC)

Cairo, 12311, Egypt

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

• Doaa Elsayed

  Department of Physical therapy for Woman's Health, Faculty of Physical Therapy, Badr University in Cairo, Cairo, Egypt

  STUDY CHAIR

• Doha Hamed

  Basic Sciences Department, Faculty of Physical Therapy, Badr University in Cairo

  STUDY CHAIR

• Ahmed Zakaria

  Department of orthopedic surgery, Helwan University

  STUDY CHAIR

• Omnya Samy

  Department of Physical Therapy for Pediatrics and Pediatric Surgery, Faculty of Physical Therapy, Badr University in Cairo

  STUDY DIRECTOR

• Fatma Zidan

  Department of Physical therapy for Neuromuscular Disorders & its Surgery, Faculty of Physical Therapy, Badr University in Cairo

  STUDY DIRECTOR

• Doaa Saeed

  Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Badr University in Cairo, Cairo, Egypt

  STUDY CHAIR

Central Study Contacts

Mina Wahba, PhD

CONTACT

01285170876; mina.magdy@the.suezuni.edu.eg

Doha Hamed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)