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

Primary Purpose

Plantar Fascitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Exercise Program
Low-Level Laser Therapy (LLLT)
Extracorporeal Shockwave Therapy (ESWT)
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring ESWT, LLLT, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ESWT Group

    LLLT Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2021
    Last Updated
    March 29, 2021
    Sponsor
    Trakya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04826263
    Brief Title
    Comparison of the Effectiveness of LLLT and ESWT in Plantar Fasciitis Treatment
    Official Title
    Comparison of the Effectiveness of Low-level Laser Therapy and Extracorporeal Shock Wave Therapy in Plantar Fasciitis Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 3, 2021 (Anticipated)
    Primary Completion Date
    May 10, 2021 (Anticipated)
    Study Completion Date
    May 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Trakya University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fascitis
    Keywords
    ESWT, LLLT, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESWT Group
    Arm Type
    Experimental
    Arm Description
    The patients in the ESWT group will receive ESWT treatment and a home exercise program.
    Arm Title
    LLLT Group
    Arm Type
    Experimental
    Arm Description
    The patients in the LLLT Group will receive LLLT treatment and a home exercise program.
    Intervention Type
    Other
    Intervention Name(s)
    Home Exercise Program
    Intervention Description
    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
    Intervention Name(s)
    Low-Level Laser Therapy (LLLT)
    Intervention Description
    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
    Intervention Name(s)
    Extracorporeal Shockwave Therapy (ESWT)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Foot Function Index (FFI)
    Description
    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.
    Time Frame
    It will be reported at baseline
    Title
    Foot Function Index (FFI)
    Description
    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.
    Time Frame
    It will be reported at the end of treatment (3 weeks)
    Title
    Gait Speed
    Description
    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.
    Time Frame
    It will be reported at baseline (5 minutes after the FFI)
    Title
    Gait Speed
    Description
    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.
    Time Frame
    It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)
    Title
    Cadence
    Description
    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.
    Time Frame
    It will be reported at baseline (5 minutes after the FFI)
    Title
    Cadence
    Description
    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.
    Time Frame
    It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Halit SELÇUK
    Phone
    +905384855543
    Email
    selcukhalit@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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