Physiotherapy Protocols in Treating Plantar Fasciitis

NCT ID: NCT04967703

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-03-01

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.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Group A

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Group B

Intervention Type: 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

Combined therapy protocol

Patients in group C received a combination of both ultrasound therapy and radial shock wave therapy protocol.

Group Type: EXPERIMENTAL

Group C

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Group C

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

Intervention Type: PROCEDURE

Other Intervention Names

Ultrasound therapy protocol; Radial shock wave therapy protocol; Combined therapy protocol

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jouf University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Z. Fouda

Associate Professor of Physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled Z. Fouda, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Physical Therapy

Locations

Al Qurayyat General Hospital

Qurayyat, Jouf Region, Saudi Arabia

Countries

Saudi Arabia

Study Documents

Document Type: Full Paper

View Document

Related Links

https://www.europeanreview.org/article/32287

Free Full Paper

Other Identifiers

H-13-S-071(068)

Identifier Type: -

Identifier Source: org_study_id