Physiotherapy Protocols in Treating Plantar Fasciitis

Plantar Fascitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967703
• Other study ID #: H-13-S-071(068)
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Al Qurayyat General Hospital	Al Qurayyat	Jouf Region

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Jouf University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot function	A modified version of the original foot function index was used to assess the change in foot function	From baseline to 4 weeks after treatment
Secondary	Ankle dorsiflexion range of motion	A Baseline® bubble inclinometer was used to assess the change in Ankle dorsiflexion range of motion	From baseline to 4 weeks after treatment

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