NCT05373225

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

April 17, 2022

Last Update Submit

July 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • FPX 50 wagner Pressure pain threshold (PPT)

    three months

  • Activity of daily living: by Foot and Ankle Ability Measure scale

    three months

  • visual analogue scale.

    three months

Study Arms (3)

Shock wave Therapy

EXPERIMENTAL

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

Device: Shock wave Therapy

Acetic acid shockwave phonophoresis therapy

EXPERIMENTAL

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

conventional physical therapy program

ACTIVE COMPARATOR

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

This group composed of subjects. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice

Acetic acid shockwave phonophoresis therapy

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

Shock wave Therapy

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

conventional physical therapy program

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Heel Spur

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

ExostosesHyperostosisBone DiseasesMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Lecturer at department of basic science and biomechanics at faculty of physical therapy

Study Record Dates

First Submitted

April 17, 2022

First Posted

May 13, 2022

Study Start

August 15, 2022

Primary Completion

November 15, 2022

Study Completion

December 15, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations