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Physiotherapy Protocols in Treating Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT04967703
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
Jouf University
Information provided by (Responsible Party):
Khaled Z. Fouda, Cairo University

Brief Summary:
This study aimed to compare 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 Achilles tendon and plantar fascia stretches. 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

Condition or disease Intervention/treatment Phase
Plantar Fascitis Procedure: Group A Procedure: Group B Procedure: Group C Not Applicable

Detailed Description:

Sixty 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 and pregnancy.

The patients were randomly assigned into 3 equal groups (n = 20). 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Different Physical Therapy Protocols in the Treatment of Chronic Plantar Fasciitis Patients
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health Shock

Arm Intervention/treatment
Experimental: Ultrasound therapy protocol
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).
Procedure: Group A
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 and plantar fascia stretch for 3 sessions per week, for 4 weeks
Other Name: Ultrasound therapy protocol

Experimental: Radial shock wave therapy protocol
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.
Procedure: Group B
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
Other Name: Radial shock wave therapy protocol

Experimental: Combined therapy protocol
Patients in group C received a combination of both ultrasound therapy and radial shock wave therapy protocol.
Procedure: Group C
Patients received both ultrasound and radial shock wave therapy, in addition to the same conventional physiotherapy program given for group A
Other Name: Combined therapy protocol




Primary Outcome Measures :
  1. Foot function [ Time Frame: From baseline to 4 weeks after treatment ]
    A modified version of the original foot function index was used to assess the change in foot function

  2. Ankle dorsiflexion range of motion [ Time Frame: From baseline to 4 weeks after treatment ]
    A Baseline® bubble inclinometer was used to assess the change in Ankle dorsiflexion range of motion



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04967703


Contacts
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Contact: Heba A. Bahy, PhD 00966598185095 heba_bahy@yahoo.com
Contact: Mohammed S. Abdelsalam, PhD 00201287232366 m.shawki@pt.cu.edu.eg

Locations
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Saudi Arabia
Al Qurayyat General Hospital Recruiting
Al Qurayyat, Jouf Region, Saudi Arabia, 77471
Contact: Khaled Z. Fouda, PhD    00966543321830    kzfouda2004@yahoo.com   
Contact: Heba A. Bahy, PhD    00966598185095    Heba_Bahy@yahoo.com   
Principal Investigator: Khaled Z. Fouda, PhD         
Sub-Investigator: Heba A. Bahy, PhD         
Sub-Investigator: Mohammed S. Abdelsalam, PhD         
Sponsors and Collaborators
Cairo University
Jouf University
Investigators
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Principal Investigator: Khaled Z. Fouda, PhD Assistant Professor of Physical Therapy
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Responsible Party: Khaled Z. Fouda, Assistant Professor of Physical therapy, Cairo University
ClinicalTrials.gov Identifier: NCT04967703    
Other Study ID Numbers: H-13-S-071(068)
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD will be shared including a summary of the results after the study completion date.
Supporting Materials: Study Protocol
Time Frame: The dead time for IPD will be 30 June. 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Khaled Z. Fouda, Cairo University:
plantar fasciitis
foot function index
ultrasound
radial shock wave
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases