Physiotherapy Protocols in Treating Plantar Fasciitis

• ClinicalTrials.gov Identifier: NCT04967703
• Recruitment Status: Completed
• First Posted: July 19, 2021
• Last Update Posted: May 23, 2023
• Sponsor: Cairo University
• Collaborator: Jouf University
• Information provided by (Responsible Party): Khaled Z. Fouda, Cairo University

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

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: March 1, 2022

Arms and Interventions

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, plantar fascia stretch, strengthening exercises and manual massage 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

Outcome Measures

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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 60 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:

• 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.

Contacts and Locations

Locations

Saudi Arabia

Al Qurayyat General Hospital

Al Qurayyat, Jouf Region, Saudi Arabia, 77471

Sponsors and Collaborators

Cairo University

Jouf University

Investigators

• Principal Investigator: Khaled Z. Fouda, PhD; Associate Professor of Physical Therapy

More Information

Additional Information:

Free Full Paper 

Study Data/Documents: Full Paper 

• Responsible Party: Khaled Z. Fouda, Associate Professor of Physical therapy, Cairo University
• ClinicalTrials.gov Identifier: NCT04967703
• Other Study ID Numbers: H-13-S-071(068)
• First Posted: July 19, 2021
• Last Update Posted: May 23, 2023
• Last Verified: May 2023

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
• Access Criteria: will be uploaded on the official site of CTR
• URL: https://www.europeanreview.org/article/32287

• 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:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases