Different Treatment Methods in Patients With Plantar Fasciitis

August 13, 2021 updated by: Seyit Çıtaker, Gazi University

Comparison of the Effectiveness of Different Treatment Methods in Patients With Plantar Fasciitis

The aim of this study is to determine the different treatment methods efficacy in adult individuals with plantar fasciitis. Pain, functionality level, range of motion, muscle performance, quality of life will be examined.

In the studies carried out to date; The comparison of the effectiveness of stretching exercises and Extracorporeal shock wave therapy (ESWT), the comparison of ESWT therapy and ultrasound therapy, the comparison of manual therapy methods and stretching exercises were studied. The effects of the use of double air cushion shoes and exercise therapy on pain management and functional status were investigated.

However, no study has been conducted to compare the effectiveness of ESWT treatment, transverse friction massage and exercise training, and to determine whether technics have superiority over each other. In this study, in addition to the evaluation of pain and functionality; joint range of motion, muscle performance and quality of life are the distinguishing features of the study. That's why researcher came up with the idea to work on this topic. This study will shed light on future studies and will contribute to the literature in the treatment of this diagnosis group. It will give us information about whether the different treatment methods researcher use in physical therapy are superior to each other.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted with adults over the age of 18, who applied to the Şanlıurfa Training and Research Hospital Physical Therapy Unit, were diagnosed with plantar fasciitis, had pain for at least 3 months, and agreed to participate in the study. Patients with diabetes, systemic inflammatory disease, previous foot injury, foot fracture or malignancy, neurological disease and pregnant women will not be included in the study. A total of 54 people will be included in the study. Patients will be divided into 3 groups of 18 people each in a randomized controlled manner with a computer program. Different treatment methods with proven effectiveness in the treatment of plantar fasciitis will be applied to each group. The 1st group will be given ESWT therapy, the 2nd group will be given transverse friction massage, and the 3rd group will be given exercises that are used in the treatment of plantar fasciitis and have proven effectiveness.

  1. Group ESWT treatment: "6000 SWT Easy" device will be used for ESWT treatment. The plantar fascia of the patients will be applied once a week for 3 weeks. In each application, 2400 beats, 2.0 bar pressure and 12 frequency doses of ESWT will be applied.
  2. Group transverse friction massage: Transverse friction massage will be applied to the plantar fascia of the patients for 3 weeks, 3 days a week, on Mondays, Wednesdays, and Fridays, with a break for 1 day and 15 minutes each. Transverse friction massage, when the patient is in the supine semi-lying position, the big toe will be dorsiflexed and the plantar fascia will be stretched, and in this position, it will be applied in the direction that will be transverse to the plantar fascia.
  3. Group exercise group: Stretching the plantar fascia and gastrocsoleus muscles of the patients, towel picking exercises with the foot intrinsic muscles, heel drop exercises will be given. All stretching and exercises will be applied once a day, 5 days a week, for 3 weeks. Plantar fascia stretching exercises will be performed with a physiotherapist; While the patient is lying in the supine position, 30 seconds of stretching will be performed using the windlass (windlass) mechanism (toes are brought to dorsi flexion). This stretch will be repeated 3 times. Gastrocsoleus stretching exercises will be studied with a physiotherapist. In the supine position, the gastrocsoleus muscles will be stretched for 10 seconds and stretching will be performed with 10 repetitions. Towel collection exercises for the foot intrinsic muscles will be practiced in 3 sets, 15 repetitions per day. Heel drop exercise will be applied in 3 sets of 15 repetitions per day.

All patients will be evaluated before treatment and 3 days after the end of 3 weeks of treatment. In the evaluations to be made; Sociodemographic information such as diagnosis, age, height, weight, education level, gender of the patients will be recorded with the prepared data registration form.

Pain sensation will be evaluated with a visual analog scale. For pain severity, a 100mm horizontal line will be written as 0 points at the beginning "no pain" and 10 points at the end of "worst pain imaginable". Patients will be asked to mark the pain patients feel on this 100 mm long horizontal line. The length of the place marked by the patient will be recorded in mm. Pain at rest, during activity, and at night will be evaluated.

Foot functional evaluation will be done with the foot function index. This index consists of 3 sub-scales in which various functional states and pain sensation are evaluated and a total of 23 questions. Patients will score the questions in these subscales between 0 and 10. It will be evaluated out of 230 points in total. The higher the score, the worse the functional status is affected.

Functional status will be evaluated with triple hop test. The patient will be asked to stand on a single extremity to be tested and hop forward 3 times consecutively at the maximum level, the total distance taken will be recorded, the average of the 3 repetitions will be taken and recorded in cm.

Joint range of motion will be evaluated with a universal goniometer. The patient will be asked to bring the ankle to dorsi flexion and plantar flexion while lying on back, and how far patient can move will be measured in degrees with a goniometer. The active maximum amount of movement made by the patient will be measured and recorded in degrees (°).

Quality of life will be evaluated with the Short Form-36 scale. The scale consists of 8 sub-parameters and 36 questions. These sub-parameters are; physical function, body pain, limitation due to physical problems, limitation due to emotional problems, emotional well-being, social function, energy/fatigue, general health perception. The higher the score obtained from the scale, the higher the patient's quality of life.

The performance of the foot flexor muscles will be evaluated with the heel rise test. While standing, the patient will be asked to raise the heel as many times as possible for 30 seconds. How many times patients raise their heels in 30 seconds will be recorded.

For this study, permission was obtained from the Harran University Health Sciences Institute Non-Drug Clinical Research Ethics Committee before starting the research.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral plantar fasciitis
  • adults over the age of 18
  • diagnosis of plantar fasciitis
  • pain for at least 3 months

Exclusion Criteria:

  • diabetes
  • systemic inflammatory disease
  • previous foot injury
  • foot fracture
  • foot malignancy
  • neurological disease
  • pregnant women.
  • Those who have received physical therapy before
  • Those who have had prp before
  • Those who have had a previous steroid injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. Group ESWT treatment
6000 SWT Easy" device will be used for ESWT treatment. The plantar fascia of the patients will be applied once a week for 3 weeks. In each application, 2400 beats, 2.0 bar pressure and 12 frequency doses of ESWT will be applied
Other: physiotherapy
The 1st group will be given ESWT therapy, the 2nd group will be given transverse friction massage, and the 3rd group will be given exercises that are used in the treatment of plantar fasciitis and have proven effectiveness
Active Comparator: 2. Group transverse friction massage
Transverse friction massage will be applied to the plantar fascia of the patients for 3 weeks, 3 days a week, on Mondays, Wednesdays, and Fridays, with a break for 1 day and 15 minutes each. Transverse friction massage, when the patient is in the supine semi-lying position, the big toe will be dorsiflexed and in this position, it will be applied in the direction that will be transverse to the plantar fascia.
Other: physiotherapy
The 1st group will be given ESWT therapy, the 2nd group will be given transverse friction massage, and the 3rd group will be given exercises that are used in the treatment of plantar fasciitis and have proven effectiveness
Active Comparator: 3. Group exercise group
Stretching the plantar fascia and gastrocsoleus muscles of the patients, towel picking exercises with the foot intrinsic muscles, heel drop exercises will be given. All stretching and exercises will be applied once a day, 5 days a week, for 3 weeks. Plantar fascia stretching exercises will be performed with a physiotherapist; While the patient is lying in the supine position, 30 seconds of stretching will be performed using the windlass (windlass) mechanism (toes are brought to dorsi flexion). This stretch will be repeated 3 times. Gastrocsoleus stretching exercises will be studied with a physiotherapist. In the supine position, the gastrocsoleus muscles will be stretched for 10 seconds and stretching will be performed with 10 repetitions. Towel collection exercises for the foot intrinsic muscles will be practiced in 3 sets, 15 repetitions per day. Heel drop exercise will be applied in 3 sets of 15 repetitions per day.
Other: physiotherapy
The 1st group will be given ESWT therapy, the 2nd group will be given transverse friction massage, and the 3rd group will be given exercises that are used in the treatment of plantar fasciitis and have proven effectiveness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain will be examined
Time Frame: three weeks
Pain sensation will be evaluated with a visual analog scale. Patients can score a minimum of 0 and a maximum of 10. Getting a high score indicates a bad situation.
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Principal Investigator: Seyit s ÇITAKER, Phd, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Anticipated)

June 14, 2022

Study Completion (Anticipated)

December 19, 2022

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRU/21.10.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the study is completed, its content will be shared with all researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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