Physiotherapy Protocols in Treating Plantar Fasciitis

Not Applicable

Completed

• Conditions: Plantar Fascitis
• Interventions: Procedure: Group B; Procedure: Group C; Procedure: Group A

• Registration Number: NCT04967703
• Lead Sponsor: Cairo University

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

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 Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-19
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-21
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial shock wave therapy protocol	Group B	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.
Combined therapy protocol	Group C	Patients in group C received a combination of both ultrasound therapy and radial shock wave therapy protocol.
Ultrasound therapy protocol	Group A	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).

Primary Outcome Measures

Name	Time	Method
Foot function	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

Name	Time	Method
Ankle dorsiflexion range of motion	From baseline to 4 weeks after treatment	A Baseline® bubble inclinometer was used to assess the change in Ankle dorsiflexion range of motion

Trial Locations

Locations (1)

Al Qurayyat General Hospital; 🇸🇦 Al Qurayyat, Jouf Region, Saudi Arabia