NCT01994759

Brief Summary

The purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

November 10, 2013

Last Update Submit

July 10, 2018

Conditions

Plantar Fasciitis

Keywords

Plantar fasciitisTreatmentTrainingGlucocorticosteroid injection

Outcome Measures

Primary Outcomes (2)

  • 100 mm VAS score pain at function. Average pain during everyday living.

    6 month

  • Foot Function Index

    Foot function Index is a validated score for patients with plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230.

    6 month

Secondary Outcomes (4)

  • 100 mm VAS score for morning pain

    at entry, 3 month (after intervention), 6 month, 12 month, 24 month

  • Ultrasound scanning thickness measure

    at entry, 3 month (after intervention), 6 month, 12 month, 24 month

  • 100 mm VAS score pain at function. Average pain during everyday living.

    3 months, 12 months, 24 months

  • Foot Function Index

    3 month, 12 month, 24 month

Other Outcomes (2)

  • patient diary

    week 1,2,3,4,5,6,7,8,9,10,11,12,13

  • Contrast Enhanced Ultrasound

    at entry after 3-4 months and after 1 year

Study Arms (3)

Training

ACTIVE COMPARATOR

strengthening and stretching exercises.

Other: TrainingBehavioral: Reduction in impact

Glucocorticosteroid injection

ACTIVE COMPARATOR

Injection of 40 mg methylprednisolone.

Drug: Glucocorticosteroid injectionBehavioral: Reduction in impact

Training and Glucocorticosteroid injections

ACTIVE COMPARATOR

A combination treatment of the two above.

Other: TrainingDrug: Glucocorticosteroid injectionBehavioral: Reduction in impact

Interventions

TrainingOTHER

Patients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly

Also known as: Heavy slow resistance exercise, Eccentric training, stretching
TrainingTraining and Glucocorticosteroid injections
Glucocorticosteroid injectionDRUG

Ultra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris. Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections).

Also known as: Methylprednisolone, Depo-medrol
Glucocorticosteroid injectionTraining and Glucocorticosteroid injections
Reduction in impactBEHAVIORAL

advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.

Also known as: Shock absorbtion
Glucocorticosteroid injectionTrainingTraining and Glucocorticosteroid injections

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain at the medial attachment of fascia plantaris.
  • First step pain in the morning
  • Symptoms for at least 3 months.
  • Age 20-65 years
  • Ultrasound scanning at the first visit shows thickness of the fascia above 4 mm.
  • Patient can read and understand danish

You may not qualify if:

  • known arthritis, inflammatory bowl disease, psoriasis or clinical signs of any of these
  • Leg ulcerations
  • Longlasting oedema of the leg and foot
  • Palpatory decreased puls in the foot
  • Diabetes
  • Reduced sensibility in the foot
  • Infections in the foot
  • Daily use of pain killers
  • Pregnancy or planning to become pregnant
  • Earlier operations on the foot, that is judged to complicate training
  • Patient assessed not to be able to participate in the training for other reasons
  • Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (11)

  • Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):701-6. doi: 10.1016/j.apmr.2008.11.002.

    PMID: 19345789BACKGROUND

  • Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.

    PMID: 12917892BACKGROUND

  • Uden H, Boesch E, Kumar S. Plantar fasciitis - to jab or to support? A systematic review of the current best evidence. J Multidiscip Healthc. 2011;4:155-64. doi: 10.2147/JMDH.S20053. Epub 2011 May 24.

    PMID: 21655342BACKGROUND

  • Vohra PK, Kincaid BR, Japour CJ, Sobel E. Ultrasonographic evaluation of plantar fascia bands. A retrospective study of 211 symptomatic feet. J Am Podiatr Med Assoc. 2002 Sep;92(8):444-9. doi: 10.7547/87507315-92-8-444.

    PMID: 12237265BACKGROUND

  • Tobin L, Simonsen L, Bulow J. Real-time contrast-enhanced ultrasound determination of microvascular blood volume in abdominal subcutaneous adipose tissue in man. Evidence for adipose tissue capillary recruitment. Clin Physiol Funct Imaging. 2010 Nov;30(6):447-52. doi: 10.1111/j.1475-097X.2010.00964.x. Epub 2010 Aug 22.

    PMID: 20731685BACKGROUND

  • Roos E, Engstrom M, Soderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle Int. 2006 Aug;27(8):606-11. doi: 10.1177/107110070602700807.

    PMID: 16919213BACKGROUND

  • Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2006 Aug 9;7:64. doi: 10.1186/1471-2474-7-64.

    PMID: 16895612BACKGROUND

  • 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

  • Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, Kaldau NC, Kjaer M, Magnusson SP. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009 Dec;19(6):790-802. doi: 10.1111/j.1600-0838.2009.00949.x. Epub 2009 May 28.

    PMID: 19793213BACKGROUND

  • Cheng JW, Tsai WC, Yu TY, Huang KY. Reproducibility of sonographic measurement of thickness and echogenicity of the plantar fascia. J Clin Ultrasound. 2012 Jan;40(1):14-9. doi: 10.1002/jcu.20903. Epub 2011 Nov 22.

    PMID: 22109854BACKGROUND

  • Johannsen FE, Herzog RB, Malmgaard-Clausen NM, Hoegberget-Kalisz M, Magnusson SP, Kjaer M. Corticosteroid injection is the best treatment in plantar fasciitis if combined with controlled training. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):5-12. doi: 10.1007/s00167-018-5234-6. Epub 2018 Nov 15.

    PMID: 30443664DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

MethylprednisoloneMethylprednisolone Acetate

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Michael Kjær, Professor

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician, MD, specialist in Rheumatology

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 26, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 1, 2016

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

DK(1)