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

NCT ID: NCT04826263

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-03

Study Completion Date

2021-05-15

Brief Summary

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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).

Detailed Description

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Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESWT Group

The patients in the ESWT group will receive ESWT treatment and a home exercise program.

Group Type EXPERIMENTAL

Home Exercise Program

Intervention Type OTHER

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.

Extracorporeal Shockwave Therapy (ESWT)

Intervention Type OTHER

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.

LLLT Group

The patients in the LLLT Group will receive LLLT treatment and a home exercise program.

Group Type EXPERIMENTAL

Home Exercise Program

Intervention Type OTHER

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.

Low-Level Laser Therapy (LLLT)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Halit SELÇUK

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Halit SELÇUK

Role: CONTACT

+905384855543

Other Identifiers

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2021-36

Identifier Type: -

Identifier Source: org_study_id

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