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Conservative Therapy Interventions in Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT03367468
Recruitment Status : Unknown
Verified October 2019 by Sulenur Yildiz, Hacettepe University.
Recruitment status was:  Recruiting
First Posted : December 8, 2017
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sulenur Yildiz, Hacettepe University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Plantar Fascitis Pain Other: Exercise Other: Mobilization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Different Conservative Therapy Interventions in Plantar Fasciitis
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367468


Contacts
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Contact: Sulenur YILDIZ, PT, MSc +903123051576 ext 139 sulenur.subasi@hacettepe.edu.tr
Contact: Nilgun BEK, PT, PhD, Professor nilgunbek@gmail.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Sulenur YILDIZ, PT, MSc       sulenur.subasi@hacettepe.edu.tr   
Sponsors and Collaborators
Sulenur Yildiz
Investigators
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Study Director: Nilgun BEK, PT, PhD, Professor Hacettepe University
Publications:

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Responsible Party: Sulenur Yildiz, Research assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT03367468    
Other Study ID Numbers: 06144834
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sulenur Yildiz, Hacettepe University:
Plantar fascitis
Pain
Exercise
Physiotherapy
Quality of life
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases