Shockwave Phonophoresis on Calcaneal Spur Patients

Calcaneal Spur Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05373225
• Other study ID #: shockwave phonophoresis
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2022
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calcaneal Spur
• Heel Spur

Intervention

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
• Shock wave Therapy
This group composed of subjects and represented the control group who will receive shock wave therapy

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Self

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calcaneal spur length by X-ray (mm)	X-ray on the affected foot to measure the length of the calcaneal spur	three months
Primary	calcaneal spur width by X-ray (mm)	X-ray on the affected foot to measure the width of the calcaneal spur	three months
Secondary	FPX 50 wagner Pressure pain threshold (PPT)	this device used to measure the pressure pain threshold	three months
Secondary	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
Secondary	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