NCT03367468

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.

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
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

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

First Submitted

Initial submission to the registry

November 10, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

November 10, 2017

Last Update Submit

October 9, 2019

Conditions

Keywords

Plantar fascitisPainExercisePhysiotherapyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Perception of pain

    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 Outcomes (1)

  • Perception of quality of life

    6 weeks

Study Arms (3)

Physiotherapy group

ACTIVE COMPARATOR

Strengthening and stretching exercises,cross friction massage (supervised by physiotherapist) Mobilization techniques Daily usage of prescribed orthotic insole

Other: ExerciseOther: Mobilization

Home exercise group

ACTIVE COMPARATOR

Strenthening and stretching exercises Daily usage of prescribed orthotic insole

Other: Mobilization

Control group

NO INTERVENTION

Follow ups Daily usage of prescribed orthotic insole

Interventions

Strengthening exercises ( extrinsic and intrinsic foot muscles) Stretcthing exercises (plantar fascia, plantar flexor muscles)

Physiotherapy group

Antero-posterior gliding, talocrural traction, metatarsal mobilization

Home exercise groupPhysiotherapy group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (11)

  • Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.

    PMID: 10229276BACKGROUND
  • Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.

    PMID: 21916393BACKGROUND
  • Podolsky R, Kalichman L. Taping for plantar fasciitis. J Back Musculoskelet Rehabil. 2015;28(1):1-6. doi: 10.3233/BMR-140485.

    PMID: 24867905BACKGROUND
  • Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouche R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010 May-Jun;49(3 Suppl):S1-19. doi: 10.1053/j.jfas.2010.01.001.

    PMID: 20439021BACKGROUND
  • Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.

    PMID: 25361863BACKGROUND
  • Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.

    PMID: 16882901BACKGROUND
  • Sweeting D, Parish B, Hooper L, Chester R. The effectiveness of manual stretching in the treatment of plantar heel pain: a systematic review. J Foot Ankle Res. 2011 Jun 25;4:19. doi: 10.1186/1757-1146-4-19.

    PMID: 21703003BACKGROUND
  • Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.

    PMID: 26655866BACKGROUND
  • Moon DC, Kim K, Lee SK. Immediate Effect of Short-foot Exercise on Dynamic Balance of Subjects with Excessively Pronated Feet. J Phys Ther Sci. 2014 Jan;26(1):117-9. doi: 10.1589/jpts.26.117. Epub 2014 Feb 6.

    PMID: 24567688BACKGROUND
  • McKeon PO, Fourchet F. Freeing the foot: integrating the foot core system into rehabilitation for lower extremity injuries. Clin Sports Med. 2015 Apr;34(2):347-61. doi: 10.1016/j.csm.2014.12.002. Epub 2015 Jan 24.

    PMID: 25818718BACKGROUND
  • Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.

    PMID: 9770933BACKGROUND

MeSH Terms

Conditions

PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nilgun BEK, PT, PhD, Professor

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

Sulenur YILDIZ, PT, MSc

CONTACT

Nilgun BEK, PT, PhD, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

November 10, 2017

First Posted

December 8, 2017

Study Start

July 15, 2018

Primary Completion

December 15, 2019

Study Completion

March 15, 2020

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations