Conservative Therapy Interventions in Plantar Fasciitis

October 9, 2019 updated by: Sulenur Yildiz

Comparison of the Different Conservative Therapy Interventions in Plantar Fasciitis

Plantar fasciitis is seen common in clinics and responsible from most of foot related pain problems. There are many treatment modalities in the literature as well as there is no golden standard to treat plantar fasciitis in non-surgical ways. The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Plantar fasciitis is frequently seen in adult population as a pain related problem of the foot. Pain, as a most prominent symptom, is caused from repetitive microtraumas and inflammation where plantar fascia attaches to the calcaneus. Pain starts from heel pad or medial tubercule of the calcaneus and spreads through plantar fascia and medial longitudinal arch.

Obesity, increased foot pronation, difference in extremity length, long standing duration and Achilles tendon tightness are some of the factors which stress plantar fascia and sometimes cause degenerative changes on it. Weakness of intrinsic muscle is also another factor which is thought to be related with plantar fasciitis.

Diagnosis is mostly depends on history and physical examination. First steps in the morning, walking after long rest, and palpation of medial tubercule of calcaneus are painful.

According to the literature, non-surgical treatment modalities relieve symptoms of patients successfully. Orthotics, night splints, manipulation interventions with conventional methods are effective to decrease pain and improve function. There are various physiotherapy treatment approaches in plantar fasciitis but there is no consensus about most effective treatment program. Stretching of plantar flexor muscles and plantar fascia is one of the core elements of the treatment plan. Strengthening exercises together with stretching were shown more effective than only stretching. Foot orthoses are thought to prevent increased pronation and relieving stress on plantar fascia in patients with plantar fasciitis. Usage of insoles with night splints is found more effective. Taping is also helpful to acute pain control. Short foot exercises as isolated intrinsic foot muscles strengthening helps to providing subtalar foot position and supports plantar fascia and foot arches. Manual techniques improve lower extremity joint mobility and decreases related pain. Extracorporeal Shock Wave Therapy is suggested to try after at least six month ineffective conservative treatments. If symptoms resist more than six months and non-conservative treatments are found ineffective, invasive approaches as steroid injections are applicable.

Treatment of this common problem in population is important to ensure patients returning in earliest period to daily life with full physical capacity. There are many conservative options to treat plantar fasciitis but best treatment program combination was not clear The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.

Study Type

Interventional

Enrollment (Anticipated)

63

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 Contact

Study Contact Backup

Study Locations

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Older than 18 years, Baseline Roles and Maudsley score > 2, Accepting and signing consent form Daily usage of insoles which was prescribed by doctor No history of systemic disease and surgery that affects foot biomechanics No history of cognitive, mental, neurological or psychological problems.

Exclusion Criteria:

Presence of chronic or active infection in treatment site, Not accepting to participate in the study Systemic, neurologic, rheumatologic,and vascular disease history, Pregnancy, BMI > 35 kg/m2, History of foot and/or ankle surgery.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physiotherapy group
Strengthening and stretching exercises,cross friction massage (supervised by physiotherapist) Mobilization techniques Daily usage of prescribed orthotic insole
Other: Exercise
Strengthening exercises ( extrinsic and intrinsic foot muscles) Stretcthing exercises (plantar fascia, plantar flexor muscles)
Other: Mobilization
Antero-posterior gliding, talocrural traction, metatarsal mobilization
Active Comparator: Home exercise group
Strenthening and stretching exercises Daily usage of prescribed orthotic insole
Other: Mobilization
Antero-posterior gliding, talocrural traction, metatarsal mobilization
No Intervention: Control group
Follow ups Daily usage of prescribed orthotic insole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of pain
Time Frame: 6 weeks

Perception of pain with Visual Analog Scale (VAS) with palpation, first steps in the morning and after long walk.

The Visual Analog Scale is a valid and reliable measure of pain intensity. To rate pain intensity a mark is placed on a 100-mm VAS. The VAS is horizontally positioned with the extremes labeled''least possible pain'' and ''worst possible pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Subjects will be asked to rate pain in three different conditions as palpation, first steps in the morning and after long walk.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of quality of life
Time Frame: 6 weeks
The World Health Organization (WHO) Quality of Life - Bref Questionnaire is a 26-item self-administered instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher score presents better quality of life.
6 weeks

Collaborators and Investigators

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

Sponsor

Sulenur Yildiz

Investigators

  • Study Director: Nilgun BEK, PT, PhD, Professor, Hacettepe 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

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)

July 15, 2018

Primary Completion (Anticipated)

December 15, 2019

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06144834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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