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Status unknownNCT05373225Updated Jul 19, 2022

Shockwave Phonophoresis on Calcaneal Spur Patients

An interventional study of Acetic acid shockwave phonophoresis therapy and Shock wave Therapy in Calcaneal Spur, sponsored by Beni-Suef University. Status unknown at 1 site in Egypt. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Calcaneal Spur

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03

In context

Heel Spur

26 studies on the registry are indexed under Heel Spur; 8 are open to participants now.

This study's planned enrollment of 60 is close to the median of 55 across 20 interventional studies indexed under Heel Spur.

Browse Heel Spur studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DeviceAcetic 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

  • DeviceShock wave Therapy

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

  • Otherconventional 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

06

What researchers measure

Primary outcomes

  1. calcaneal spur length by X-ray (mm)

    X-ray on the affected foot to measure the length of the calcaneal spur

    Time frame: three months

  2. calcaneal spur width by X-ray (mm)

    X-ray on the affected foot to measure the width of the calcaneal spur

    Time frame: three months

Secondary outcomes

  1. FPX 50 wagner Pressure pain threshold (PPT)

    this device used to measure the pressure pain threshold

    Time frame: three months

  2. 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

    Time frame: three months

  3. 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)

    Time frame: three months

07

Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Giza, Egypt
    • Nabil Abdel-Aal, PhD · Contact · nabil.mahmoud@cu.edu.eg · +201200133613
    • Nabil M Abdel-Aal, PHD · Principal investigator
    • Fatama SEDDEK, PHD · Principal investigator
    • Mostafa Elwan, MSc. · Principal investigator
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · May 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05373225
Lead sponsor
Beni-Suef University
Collaborators
Self
Responsible party
Mostafa Ali Elwan (Assistance Lecturer at department of basic science and biomechanics at faculty of physical therapy, Beni-Suef University) — Principal investigator
First posted
May 13, 2022
Start date
Aug 15, 2022 (estimated)
Primary completion
Nov 15, 2022 (estimated)
Completion
Dec 15, 2022 (estimated)
Last update
Jul 19, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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