Shockwave Phonophoresis on Calcaneal Spur Patients

Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal Spur Patients: A Randomized Controlled Trial

The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Therefore, the present study might help in the treatment of calcaneal spur patients and also might improve the quality of life in a fast and efficient way.

Study Overview

• Status: Not yet recruiting
• Conditions: Calcaneal Spur
• Intervention / Treatment: Device: Shock wave Therapy; Device: Acetic acid shockwave phonophoresis therapy; Other: conventional physical therapy program

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of physical therapy, Cairo University
    • Contact: Nabil Abdel-Aal, PhD; Phone Number: +201200133613; Email: nabil.mahmoud@cu.edu.eg
    • Principal Investigator: Nabil M Abdel-Aal, PHD
    • Principal Investigator: Fatama SEDDEK, PHD
    • Principal Investigator: Mostafa Elwan, MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Heel pain with a calcaneal spur.
• Calcaneal spur in a lateral calcaneal x-ray.
• Patient's age ranged from 30 to 65 years.
• Patients with a calcaneal spur.
• Patients with intact sensory perception.
• At least 6 weeks from last corticosteroid injection; 4 weeks from the last local anaesthetic injection, iontophoresis, ultrasound, and electrotherapy

Exclusion Criteria:

• History of fracture or surgery of the heel or ankle.
• Presence of inflammatory joint disease.
• Marked osteoporotic patient.
• Presence of ankylosing spondylitis or other inflammatory joint diseases.
• Heart pacemaker use.
• Patient on anticoagulant and coagulation disease.
• Skin wound or ulcers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shock wave Therapy; This group will be composed of subjects who represented the experimental group 1. They will receive shock wave therapy	Device: Shock wave Therapy; This group composed of subjects and represented the control group who will receive shock wave therapy
Experimental: Acetic acid shockwave phonophoresis therapy; This group will be composed of subjects who represented the experimental group 2. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice	Device: Acetic acid shockwave phonophoresis therapy; This group composed of subjects. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice
Active Comparator: conventional physical therapy program; This group will be composed of subjects who represented the control group Exercise program: Standing calf-stretching exercise; Towel stretch: stretching exercise; Ice bottle; Towel pickup exercise; Marble pickups exercise; Calf raises exercises -Static and dynamic balance exercise	Other: conventional physical therapy program; Exercise program: Standing calf-stretching exercise; Towel stretch: stretching exercise; Ice bottle; Towel pickup exercise; Marble pickups exercise; Calf raises exercises -Static and dynamic balance exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calcaneal spur length by X-ray (mm)	X-ray on the affected foot to measure the length of the calcaneal spur	three months
calcaneal spur width by X-ray (mm)	X-ray on the affected foot to measure the width of the calcaneal spur	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FPX 50 wagner Pressure pain threshold (PPT)	this device used to measure the pressure pain threshold	three months
Activity of daily living: by Foot and Ankle Ability Measure scale	This scale formed from 29 item, the minimum score for each item is 0 and maximum score is 4 , the Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction	three months
visual analogue scale.	this scale for pain intensity level assessment and contain minimum score is 0 and maximum score is 100 mm, the higher score indicate more pain (sever dysfunction)	three months

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Self

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2022
• Primary Completion (Anticipated): November 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Bone Diseases; Exostoses; Hyperostosis; Heel Spur; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunologic Factors; Protective Agents; Anti-Bacterial Agents; Adjuvants, Immunologic; Anticarcinogenic Agents; Acetic Acid; Retinol acetate
• Other Study ID Numbers: shockwave phonophoresis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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