Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04826263
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Halit SELÇUK, Trakya University

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).

Condition or disease Intervention/treatment Phase
Plantar Fascitis Other: Home Exercise Program Other: Low-Level Laser Therapy (LLLT) Other: Extracorporeal Shockwave Therapy (ESWT) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Low-level Laser Therapy and Extracorporeal Shock Wave Therapy in Plantar Fasciitis Treatment
Estimated Study Start Date : April 3, 2021
Estimated Primary Completion Date : May 10, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.




Primary Outcome Measures :
  1. Foot Function Index (FFI) [ Time Frame: It will be reported at baseline ]
    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.

  2. Foot Function Index (FFI) [ Time Frame: It will be reported at the end of treatment (3 weeks) ]
    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.

  3. Gait Speed [ Time Frame: It will be reported at baseline (5 minutes after the FFI) ]
    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.

  4. Gait Speed [ Time Frame: It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI) ]
    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.

  5. Cadence [ Time Frame: It will be reported at baseline (5 minutes after the FFI) ]
    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.

  6. Cadence [ Time Frame: It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826263


Contacts
Layout table for location contacts
Contact: Halit SELÇUK +905384855543 selcukhalit@gmail.com

Sponsors and Collaborators
Trakya University
Layout table for additonal information
Responsible Party: Halit SELÇUK, Principal Investigator, Trakya University
ClinicalTrials.gov Identifier: NCT04826263    
Other Study ID Numbers: 2021-36
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halit SELÇUK, Trakya University:
ESWT
LLLT
Exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases