Physiotherapy Protocols in Treating Plantar Fasciitis

NCT04967703 | Completed

• 1 other identifier: H-13-S-071(068)
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

Plantar Fascitis

Keywords

plantar fasciitis; foot function index; ultrasound; radial shock wave

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ankle dorsiflexion range of motion

  From baseline to 4 weeks after treatment

Study Arms (3)

Ultrasound therapy protocol

EXPERIMENTAL

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).

Procedure: Group A

Radial shock wave therapy protocol

EXPERIMENTAL

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.

Procedure: Group B

Combined therapy protocol

EXPERIMENTAL

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

Procedure: Group C

Interventions

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

Also known as: Ultrasound therapy protocol

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

Also known as: Radial shock wave therapy protocol

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

Also known as: Combined therapy protocol

Combined therapy protocol

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Jouf University: collaborator

Study Sites (1)

Al Qurayyat General Hospital

Qurayyat, Jouf Region, 77471, Saudi Arabia

Location

Related Links

• Free Full Paper

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Khaled Z. Fouda, PhD

  Associate Professor of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical therapy

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 19, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 1, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The dead time for IPD will be 30 June. 2024
• Access Criteria: will be uploaded on the official site of CTR

Locations

SA (1)