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Completed

NCT Number: NCT04967703

Physiotherapy Protocols in Treating Plantar Fasciitis

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

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Qurayyat General Hospital

Qurayyat, Jouf Region, 77471, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group A

Procedure

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 names: Ultrasound therapy protocol

Group B

Procedure

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 names: Radial shock wave therapy protocol

group C

Procedure

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

Other names: Combined therapy protocol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Jouf University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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