Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04826263
Other study ID # 2021-36
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 3, 2021
Est. completion date May 15, 2021

Study information

Verified date March 2021
Source Trakya University
Contact Halit SELÇUK
Phone +905384855543
Email selcukhalit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date May 15, 2021
Est. primary completion date May 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
See also
  Status Clinical Trial Phase
Completed NCT05071365 - Early Access to Virtual Resources for the Self-management of Plantar Fasciitis N/A
Not yet recruiting NCT05479526 - Effect of The Superficial Back Line on the Development of Plantar Fasciitis
Not yet recruiting NCT05479500 - Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis N/A
Recruiting NCT04423900 - Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain N/A
Completed NCT04204824 - Ultrasound Treatment in the Management of Plantar Fasciitis N/A
Completed NCT04162262 - Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment N/A
Completed NCT03246087 - Acupuncture for Plantar Fasciosis in the Primary Care Setting N/A
Completed NCT05647291 - Is ESWT Better in Plantar Fasciitis Treatment? N/A
Withdrawn NCT03873207 - Offloading Device for Post Surgical Foot Procedures N/A
Completed NCT05347264 - Comparative Effects of Gun Massager and Transverse Friction Massage in Patients With Plantar Fasciitis N/A
Recruiting NCT04175288 - The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis N/A
Completed NCT03731897 - Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study N/A
Recruiting NCT05462002 - Intrinsic Foot Muscle Morphology and Function in Runners With and Without Plantar Fasciitis
Active, not recruiting NCT06466616 - Shock Waves Combined With Leg Stretches in Patients With Plantar Fasciitis N/A
Completed NCT05207592 - Urdu Version of Foot and Ankle Disability Index: A Reliability and Validity Study
Not yet recruiting NCT06394336 - Early Intervention With Therapeutic Exercise in Plantar Fasciopathy N/A
Completed NCT06023836 - Myofascial Pain Syndrome and Plantar Fasciitis Treatment N/A
Completed NCT05856019 - Effects of J Stroke Myofascial Release in Patients With Planter Fasciitis N/A
Completed NCT05867888 - Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis N/A
Completed NCT06446167 - Comparative Efficacy of Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes N/A