Physiotherapy Protocols in Treating Plantar Fasciitis

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • 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
  • 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
  • Procedure: Group C
    • Patients received both ultrasound and radial shock wave therapy, in addition to the same conventional physiotherapy program given for group A

Arms, Groups and Cohorts

  • 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).
  • 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.
  • Experimental: Combined therapy protocol
    • Patients in group C received a combination of both ultrasound therapy and radial shock wave therapy protocol.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Collaborator
    • Jouf University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Khaled Z. Fouda, Associate Professor of Physical therapy – Cairo University
  • Overall Official(s)
    • Khaled Z. Fouda, PhD, Principal Investigator, Associate Professor of Physical Therapy

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