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Shockwave Phonophoresis on Calcaneal Spur Patients

Primary Purpose

Calcaneal Spur

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acetic acid shockwave phonophoresis therapy
Shock wave Therapy
conventional physical therapy program
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneal Spur

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Shock wave Therapy

Acetic acid shockwave phonophoresis therapy

conventional physical therapy program

Arm Description

This group will be composed of subjects who represented the experimental group 1. They will receive shock wave 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

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

Outcomes

Primary Outcome Measures

calcaneal spur length by X-ray (mm)
X-ray on the affected foot to measure the length of the calcaneal spur
calcaneal spur width by X-ray (mm)
X-ray on the affected foot to measure the width of the calcaneal spur

Secondary Outcome Measures

FPX 50 wagner Pressure pain threshold (PPT)
this device used to measure the pressure pain threshold
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
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)

Full Information

First Posted
April 17, 2022
Last Updated
July 18, 2022
Sponsor
Beni-Suef University
Collaborators
Self
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1. Study Identification

Unique Protocol Identification Number
NCT05373225
Brief Title
Shockwave Phonophoresis on Calcaneal Spur Patients
Official Title
Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal Spur Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Self

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneal Spur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shock wave Therapy
Arm Type
Experimental
Arm Description
This group will be composed of subjects who represented the experimental group 1. They will receive shock wave therapy
Arm Title
Acetic acid shockwave phonophoresis therapy
Arm Type
Experimental
Arm Description
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
Arm Title
conventional physical therapy program
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Acetic acid shockwave phonophoresis therapy
Intervention Description
This group composed of subjects. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice
Intervention Type
Device
Intervention Name(s)
Shock wave Therapy
Intervention Description
This group composed of subjects and represented the control group who will receive shock wave therapy
Intervention Type
Other
Intervention Name(s)
conventional physical therapy program
Intervention Description
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
Primary Outcome Measure Information:
Title
calcaneal spur length by X-ray (mm)
Description
X-ray on the affected foot to measure the length of the calcaneal spur
Time Frame
three months
Title
calcaneal spur width by X-ray (mm)
Description
X-ray on the affected foot to measure the width of the calcaneal spur
Time Frame
three months
Secondary Outcome Measure Information:
Title
FPX 50 wagner Pressure pain threshold (PPT)
Description
this device used to measure the pressure pain threshold
Time Frame
three months
Title
Activity of daily living: by Foot and Ankle Ability Measure scale
Description
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
Time Frame
three months
Title
visual analogue scale.
Description
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)
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabil Abdel-Aal, PhD
Phone
+201200133613
Email
nabil.mahmoud@cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nabil M Abdel-Aal, PHD
First Name & Middle Initial & Last Name & Degree
Fatama SEDDEK, PHD
First Name & Middle Initial & Last Name & Degree
Mostafa Elwan, MSc.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Shockwave Phonophoresis on Calcaneal Spur Patients

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