Comparions the Effect of Different Treatment Modalities on Chronic Plantar Fasiitis

NCT04323319 | Completed DMC

• 1 other identifier: BAP.2018-03.01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Plantar fasciitis is a common cause of heel pain affecting about 20% of the general population. The basic treatment of plantar fasciitis is conservative. Approximately 85-90% of plantar fasciitis patients can be successfully treated without surgery. Methods include resting, nonsteroidal anti-inflammatory drugs, stretching, shoe orthotics, corticosteroid injections, physical therapy, night splints, and extracorporeal shock wave therapy (ESWT) and ultrasound therapy. Plantar fasciitis treatment is a chronic treatment that has been clearly described in the literature despite the use of treatment modalities. In the literature, treatment modalities which should be used respectively in the treatment of plantar fasciitis are expressed. Nevertheless, it is a chronic disease caused by skipping the treatment steps for various reasons or applying the treatments in the wrong hierarchy. The aim of this project is to compare the effects of stretching exercises, ESWT and instrument-assisted myofascial relaxation technique (Graston Technique®) in the treatment of chronic plantar fasciitis in terms of pain, disability level, quality of life and static and dynamic plantar pressure analysis.

Conditions

Plantar Fasciitis, Chronic

Keywords

Plantar Fasciitis; Extracorporeal shock wave therapy; Graston Technique; Instrument assisted soft tissue mobilization; Stretching; Plantar pressure analysis

Outcome Measures

Primary Outcomes (3)

• First step pain: Visuel Analog Scale (VAS)

  Visuel Analog Scale by using 10 cm likert scale.

  Changes in the VAS scores of the three groups before the treatment.

• First step pain: Visuel Analog Scale (VAS)

  Visuel Analog Scale by using 10 cm likert scale.

  Changes in the VAS scores of the three groups 4 weeks after treatment.

• First step pain: Visuel Analog Scale (VAS)

  Visuel Analog Scale by using 10 cm likert scale.

  Changes in the VAS scores of the three groups 8 weeks after treatment.

Secondary Outcomes (6)

• Pressure Pain Threshold

  Changes in the pressure pain threshold (mean value of three measurement) of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.

• Kinesiophobia

  Changes in the Tampa scores of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.

• Foot Function Index

  Changes in the Foot function Index scores of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.

• SF-12

  Pre-intervention, 5th weeks (post-intervention) and 8th weeks.

• Plantar Pressure Analysis

  Changes in the VAChanges in the Plantar Pressure Analysis of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.

Study Arms (3)

ESWT Group

EXPERIMENTAL

Patients in the ESWT group will be treated with ESWT once a week for 4 weeks. Each patient was treated with epine calcaneus and its surroundings. The treatment dose of 10 Hz, 2.5 bar, 2000 shock wave with BTL L-6000 SWT device will be applied by the same therapist. Patient completed plantar fascia and gastrocnemius streching exercises right after treatment. The patient completed the plantar fascia and gastrocnemius stretching exercises right after treatment and also continue at home for 4 weeks, 2 sets per day. Completed 3 repetation for each exercise and stayed in the same position for 30 seconds.

Device: ESWT, Graston Technique

Graston Technique® Group

EXPERIMENTAL

The application was carried out by Graston Technique® (GT®) certified, a therapist with orthopedic rehabilitation and soft tissue treatments for over 12 years. GT® instruments were used to diagnose and treat the damaged soft tissue of gastrocnemius and plantar fascia. The application protocol and the instruments used according to the regions were determined with reference to the GT® manual. GT® treatment can be given to the same region twice a week. A minimum of 2 days break was given between the applications. Gastrocnemius and plantar fascia application completed in 5 minutes in one leg. GT2, GT4 and GT6 instruments used for application.The patient completed the plantar fascia and gastrocnemius stretching exercises right after treatment and also continue at home for 4 weeks, 2 sets per day. Completed 3 repetation for each exercise and stayed in the same position for 30 seconds.

Device: ESWT, Graston Technique

Control Group

EXPERIMENTAL

Stretching group was accepted as the control group. the patient monitored once a week at the hospital and continue home stretching program at home. These patients will be given information about plantar fasciitis as well as other groups. Plantar fascia and gastrosoleus self-stretching exercises will be required to be performed twice a day for thirty seconds and three repetitions for 4 weeks. The patients will be followed with an exercise follow-up form.

Device: ESWT, Graston Technique

Interventions

ESWT, Graston Technique DEVICE

The treatment period for each group was determined as 4 weeks. Stretching program for each group will be given as home exercise program. Stretching exercises will be completed in 3 sets, 2 sets per day, stretching for 30 seconds. Graston Technique Group will take treatment 2 times per week, ESWT group will take treatment 1 time per week.

Also known as: stretching

Control Group; ESWT Group; Graston Technique® Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis with plantar fasciitis, between age o 18-60 and have pain for more than 3 months,
• patients with at least 3 conservative treatments were unsuccessful (include usage of anti-inflammatory drugs, cortisone injection and surgical),
• according to Visual Analogue Scale (VAS), patients with (VAS)≥5

You may not qualify if:

• calcaneal fracture and implants,
• tarsal tunnel syndrome,
• infection,
• neurological problems,
• tumor,
• coagulated impairments,
• pregnancy

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Pelin Pişirici

Istanbul, Beşiktaş/İstanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Pelin Pişirici, PT, PhD

  Medipol University Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Dilber Karagozoglu Coskunsu, PT, PhD

  Bahçeşehir University Faculty of Health Sciences

  STUDY DIRECTOR

• Feryal Subaşı, PT, Prof

  Yeditepe University Faculty of Health Sciences

  STUDY CHAIR

• Uğur Şaylı, MD. Prof.

  Yeditepe University Hospital

  STUDY CHAIR

• Elif Tugce Cil, PT, MSc

  Yeditepe University Faculty of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There is blind assessor who has 20 year experienced PhD PT. Participants are also blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PHD (c), Lecturer

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: March 26, 2020
• Study Start: December 27, 2018
• Primary Completion: January 30, 2020
• Study Completion: March 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

TU (1)