Effect of Extracorporeal Shockwave Therapy, High Power-LASER & Platelet-rich Protein on Pain and Function in Females With Calcaneal Spur A Randomized Comparative Study.

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?

Study Overview

• Status: Completed
• Conditions: Calcaneal Spur
• Intervention / Treatment: Other: Shockwave therapy; Other: High power LASER; Other: Ice application; Other: Sham LASER; Drug: Platelet rich plasma

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 12311
      • Badr University in Cairo (BUC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shockwave therapy; Shockwave therapy for calcaneal spur	Other: Shockwave therapy; Shockwave therapy sessions for the heel
Experimental: High-power LASER therapy; High-power LASER therapy for calcaneal spur	Other: High power LASER; High power LASER sessions for the heel
Sham Comparator: Control; cold application with receive 6 sessions of sham LASER therapy.	Other: Ice application; Ice application for the heel; Other: Sham LASER; Sham LASER for the heel
Experimental: Platelet rich plasma; Platelet-rich plasma injection for the heel	Drug: Platelet rich plasma; Platelet-rich plasma for the heel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Helwan University; Badr University; Suez University
• Investigators: Study Chair: 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 Director: 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 Chair: Doaa Saeed, Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Badr University in Cairo, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Foot Diseases; Exostoses; Hyperostosis; Heel Spur; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: SU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No