Comparison of the Effectiveness of LLLT and ESWT in Plantar Fasciitis Treatment

Comparison of the Effectiveness of Low-level Laser Therapy and Extracorporeal Shock Wave Therapy in Plantar Fasciitis Treatment

The aim of this study is to compare the efficacy of extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) in terms of pain, disability, activity limitation, gait speed, and cadence in patients with plantar fasciitis (PF).

Study Overview

• Status: Not yet recruiting
• Conditions: Plantar Fascitis
• Intervention / Treatment: Other: Home Exercise Program; Other: Extracorporeal Shockwave Therapy (ESWT); Other: Low-Level Laser Therapy (LLLT)

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Halit SELÇUK; Phone Number: +905384855543; Email: selcukhalit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Experience pain on the medial tuberosity or medial process of plantar fascia within the past one month
• Diagnosed with plantar fasciitis

Exclusion Criteria:

• arthritis in the foot or ankle
• Cardiac arrhythmia or pacemaker
• Previous foot or ankle surgery
• Cancer or tumor, acute trauma
• BMI over 40 kg/m2
• Corticosteroid injection in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESWT Group; The patients in the ESWT group will receive ESWT treatment and a home exercise program.	Other: Home Exercise Program; All patients will be instructed to follow a home exercise program for 3 weeks. Patients will be informed about the exercises by giving an exercise sheet describing the exercises and an exercise diary prepared to mark the days they exercise. The home exercise program will include previously recommended exercises such as Achilles tendon and plantar fascia stretching and toe curl exercises. Patients will be instructed to perform these exercises 10 repetitions each and 3 times per day for three weeks.; Other: Extracorporeal Shockwave Therapy (ESWT); Patients in the ESWT group will receive treatment with a radial ESWT system (EMS Swiss Dolor Clast), which transforms kinetic energy into a shock wave, which is then applied to the target tissue with pressure varying from 1 to 10 bar and penetrating up to 40 mm. The ESWT treatment will be administered to the patients once a week for three weeks, for a total dose of 2000 mJ/mm2 pulse per application. ESWT will be applied to the patients in prone position with their foot inverted. Ultrasound gel will be applied to the patient's heel The area of tenderness will be palpated and 1000 shock wave impulses were applied to this area, and 1000 pulses will be applied over the plantar fascia.
Experimental: LLLT Group; The patients in the LLLT Group will receive LLLT treatment and a home exercise program.	Other: Home Exercise Program; All patients will be instructed to follow a home exercise program for 3 weeks. Patients will be informed about the exercises by giving an exercise sheet describing the exercises and an exercise diary prepared to mark the days they exercise. The home exercise program will include previously recommended exercises such as Achilles tendon and plantar fascia stretching and toe curl exercises. Patients will be instructed to perform these exercises 10 repetitions each and 3 times per day for three weeks.; Other: Low-Level Laser Therapy (LLLT); Patients in the LLLT group will receive gallium-aluminum-arsenide (Ga-Al-As) low-level laser treatment with Chattanooga Vectra Genisys Transport model (Chattanooga Group) with a wavelength of 850 nm and a power of 100 mW. The LLLT treatment will be applied 3 times a week, a total of 10 sessions. A maximum energy density of 5.6 j/cm2 will be reached by delivering a continuously increasing dose of energy to each tender spot for one minute. The LLLT will be performed with patients in the prone position and will be applied to 5 points on the plantar fascia by positioning the laser head perpendicular to the treatment area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function Index (FFI)	FFI is a valid and reliable self-administered questionnaire that can evaluate the pain, activity limitation, and disability caused by foot and ankle disorders. A modified version of the Foot Function Questionnaire developed by Venditto et al. will be used for the study, which comprises 17 items (17-IFFI) separated into three subscales; pain (5 items), disability (9 items), and activity limitation (3 items). The VAS in the original version has been substituted with the Numerical Rating Scale (NRS) which is an 11-point scale from 0 to 10. The modified version of FFI has been reported to be a reliable and valid scale and its use has been recommended for musculoskeletal foot and ankle disorders including plantar fasciitis.	It will be reported at baseline
Foot Function Index (FFI)	FFI is a valid and reliable self-administered questionnaire that can evaluate the pain, activity limitation, and disability caused by foot and ankle disorders. A modified version of the Foot Function Questionnaire developed by Venditto et al. will be used for the study, which comprises 17 items (17-IFFI) separated into three subscales; pain (5 items), disability (9 items), and activity limitation (3 items). The VAS in the original version has been substituted with the Numerical Rating Scale (NRS) which is an 11-point scale from 0 to 10. The modified version of FFI has been reported to be a reliable and valid scale and its use has been recommended for musculoskeletal foot and ankle disorders including plantar fasciitis.	It will be reported at the end of treatment (3 weeks)
Gait Speed	Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. The subjects walking time will be recorded in seconds. Gait speed will be measured by dividing the 100 meters distance by the patients' walking time.	It will be reported at baseline (5 minutes after the FFI)
Gait Speed	Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. The subjects walking time will be recorded in seconds. Gait speed will be measured by dividing the 100 meters distance by the patients' walking time.	It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)
Cadence	Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. Cadence will be measured by the number of steps in the walking test.	It will be reported at baseline (5 minutes after the FFI)
Cadence	Patients will be instructed to walk a 25 meters corridor back and forth for 4 times (100 m total). Patients will be instructed to walk as quickly as possible but running will not be allowed. Cadence will be measured by the number of steps in the walking test.	It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 3, 2021
• Primary Completion (Anticipated): May 10, 2021
• Study Completion (Anticipated): May 15, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; LLLT; ESWT
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 2021-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No