NCT05011695

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 10, 2021

Last Update Submit

August 13, 2021

Conditions

Keywords

Plantar fasciitisexerciseESWTphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Pain will be examined

    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

Study Arms (3)

1. Group ESWT treatment

ACTIVE COMPARATOR

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

2. Group transverse friction massage

ACTIVE COMPARATOR

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

3. Group exercise group

ACTIVE COMPARATOR

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

Interventions

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 treatment2. Group transverse friction massage3. Group exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Wheeler PC, Tattersall C. Extracorporeal Shockwave Therapy Plus Rehabilitation for Patients With Chronic Plantar Fasciitis Might Reduce Pain and Improve Function but Still Not Lead to Increased Activity: A Case-Series Study With Multiple Outcome Measures. J Foot Ankle Surg. 2018 Mar-Apr;57(2):339-345. doi: 10.1053/j.jfas.2017.07.001. Epub 2017 Oct 9.

  • Ugurlar M, Sonmez MM, Ugurlar OY, Adiyeke L, Yildirim H, Eren OT. Effectiveness of Four Different Treatment Modalities in the Treatment of Chronic Plantar Fasciitis During a 36-Month Follow-Up Period: A Randomized Controlled Trial. J Foot Ankle Surg. 2018 Sep-Oct;57(5):913-918. doi: 10.1053/j.jfas.2018.03.017.

Related Links

MeSH Terms

Conditions

Fasciitis, PlantarMotor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Seyit s ÇITAKER, Phd

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will not know which treatment group they are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be divided into 3 groups. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 18, 2021

Study Start

June 11, 2021

Primary Completion

June 14, 2022

Study Completion

December 19, 2022

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

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

Locations