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Physiotherapy Protocols in Treating Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Group A
Group B
Group C
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring plantar fasciitis, foot function index, ultrasound, radial shock wave

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffered plantar fasciitis of more than 3 months
  • Maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning

Exclusion Criteria:

  • Bilateral plantar fasciitis
  • Previous ankle or foot surgery or pathology
  • If they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot
  • Circulatory disturbances in the lower extremities
  • Neuropathic or radicular pain in the lower limb
  • Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.

Sites / Locations

  • Al Qurayyat General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ultrasound therapy protocol

Radial shock wave therapy protocol

Combined therapy protocol

Arm Description

Patients in group A received ultrasound therapy protocol with the following parameters (1 MHz frequency, intensity of 1.5 W/cm2 and use of continuous mode of ultrasound for 5 minutes).

Patients in group B received radial shock wave therapy protocol with the following parameters: (1) the energy level was 0.12 mJ/mm2 equivalent to 2.5 bar intensity, (2) the number of shoots was 2000, (3) the frequency was 8 Hz.

Patients in group C received a combination of both ultrasound therapy and radial shock wave therapy protocol.

Outcomes

Primary Outcome Measures

Foot function
A modified version of the original foot function index was used to assess the change in foot function

Secondary Outcome Measures

Ankle dorsiflexion range of motion
A Baseline® bubble inclinometer was used to assess the change in Ankle dorsiflexion range of motion

Full Information

First Posted
July 7, 2021
Last Updated
May 21, 2023
Sponsor
Cairo University
Collaborators
Jouf University
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1. Study Identification

Unique Protocol Identification Number
NCT04967703
Brief Title
Physiotherapy Protocols in Treating Plantar Fasciitis
Official Title
Effect of Radial Shock Wave and Ultrasound Therapy Combined With Traditional Physical Therapy Exercises on Foot Function and Dorsiflexion Range in Plantar Fasciitis: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Jouf University

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
This study aimed to investigate the efficacy of different physical therapy protocols in the treatment of chronic plantar fasciitis patients. Patients in this study were randomly assigned into 3 groups. Group A received ultrasound therapy protocol, group B received radial shock wave therapy protocol and group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients were also received a traditional physical therapy program. Foot function was evaluated by foot function index and ankle dorsiflexion range of motion was measured by Baseline® bubble inclinometer at the baseline and 4 weeks after treatment
Detailed Description
Sixty nine patients having unilateral chronic plantar fasciitis will be recruited for the study from Al-Qurayyat General Hospital, in Al-Jouf Region, Saudi Arabia. The inclusion criteria were as follows: patients suffered planter fasciitis of more than 3 months, maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning. Patients were excluded if they had previous ankle or foot surgery or pathology, or if they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot, circulatory disturbances in the lower extremities, neuropathic or radicular pain in the lower limbs. Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study. The patients were randomly assigned into 3 equal groups (n = 23). Group A received ultrasound therapy protocol using Enraf Nonius Sonoplus 490, Netherlands. Group B received radial shock wave therapy protocol using Swiss DolorClast® Master, Electro Medical Systems, SA, Nyon, Switzerland. Group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients also received a traditional physical therapy program (3 sessions per week, for 4 weeks) consisting of Calf muscles stretching and plantar fascia stretching. Foot function and Ankle dorsiflexion range of motion were evaluated at the baseline and 4 weeks after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
plantar fasciitis, foot function index, ultrasound, radial shock wave

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ultrasound therapy protocol
Arm Type
Experimental
Arm Description
Patients in group A received ultrasound therapy protocol with the following parameters (1 MHz frequency, intensity of 1.5 W/cm2 and use of continuous mode of ultrasound for 5 minutes).
Arm Title
Radial shock wave therapy protocol
Arm Type
Experimental
Arm Description
Patients in group B received radial shock wave therapy protocol with the following parameters: (1) the energy level was 0.12 mJ/mm2 equivalent to 2.5 bar intensity, (2) the number of shoots was 2000, (3) the frequency was 8 Hz.
Arm Title
Combined therapy protocol
Arm Type
Experimental
Arm Description
Patients in group C received a combination of both ultrasound therapy and radial shock wave therapy protocol.
Intervention Type
Procedure
Intervention Name(s)
Group A
Other Intervention Name(s)
Ultrasound therapy protocol
Intervention Description
Patients received ultrasound therapy protocol with the following parameters (1 MHz frequency, intensity of 1.5 W/cm2 and use of continuous mode of ultrasound for 5 minutes), in addition to a conventional physiotherapy program consisting of calf muscles stretching, plantar fascia stretch, strengthening exercises and manual massage for 3 sessions per week, for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
Group B
Other Intervention Name(s)
Radial shock wave therapy protocol
Intervention Description
Patients received radial shock wave therapy protocol with the following parameters (1) the energy level was 0.12 mJ/mm2 equivalent to 2.5 bar intensity, (2) the number of shoots was 2000, (3) the frequency was 8 Hz, in addition to the same conventional physiotherapy program given for group A
Intervention Type
Procedure
Intervention Name(s)
Group C
Other Intervention Name(s)
Combined therapy protocol
Intervention Description
Patients received both ultrasound and radial shock wave therapy, in addition to the same conventional physiotherapy program given for group A
Primary Outcome Measure Information:
Title
Foot function
Description
A modified version of the original foot function index was used to assess the change in foot function
Time Frame
From baseline to 4 weeks after treatment
Secondary Outcome Measure Information:
Title
Ankle dorsiflexion range of motion
Description
A Baseline® bubble inclinometer was used to assess the change in Ankle dorsiflexion range of motion
Time Frame
From baseline to 4 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffered plantar fasciitis of more than 3 months Maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning Exclusion Criteria: Bilateral plantar fasciitis Previous ankle or foot surgery or pathology If they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot Circulatory disturbances in the lower extremities Neuropathic or radicular pain in the lower limb Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Z. Fouda, PhD
Organizational Affiliation
Associate Professor of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Qurayyat General Hospital
City
Al Qurayyat
State/Province
Jouf Region
ZIP/Postal Code
77471
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD will be shared including a summary of the results after the study completion date.
IPD Sharing Time Frame
The dead time for IPD will be 30 June. 2024
IPD Sharing Access Criteria
will be uploaded on the official site of CTR
IPD Sharing URL
https://www.europeanreview.org/article/32287
Links:
URL
https://www.europeanreview.org/article/32287
Description
Free Full Paper
Available IPD and Supporting Information:
Available IPD/Information Type
Full Paper
Available IPD/Information URL
http://www.europeanreview.org/article/32287

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Physiotherapy Protocols in Treating Plantar Fasciitis

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