Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.
NCT ID: NCT01994759
Last Updated: 2018-07-11
Study Results
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Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2013-09-01
2016-12-01
Brief Summary
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Detailed Description
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Orthosis and glucocorticoid injections are 2 widely used treatments with proven effect. However treatment of overuse injury in other tendon/aponeurosis-like structures, has over the later years been dominated by an increasing documentation of a good curative effect of heavy controlled mechanical loading (eccentric strength exercises or heavy slow concentric strength training) upon tendinopathies in Achilles or patella tendon. However, no studies have looked at the influence of physical training (e.g. strength training) on the diseased plantar aponeurosis. Also no studies have looked at the effect of a combination of giving local glucocorticoid injection and training on this or other tendon overuse entities.
We hypothesize that heavy strength training will have a positive effect upon PF, and that a combination of training and glucocorticoid injections will have an additive effect upon this disease and be even more effective than each of the treatments alone. Glucocorticoid injection acting as the standard control treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Training
strengthening and stretching exercises.
Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Training
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
Glucocorticosteroid injection
Injection of 40 mg methylprednisolone.
Glucocorticosteroid injection
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).
Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Training and Glucocorticosteroid injections
A combination treatment of the two above.
Glucocorticosteroid injection
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).
Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Training
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
Interventions
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Glucocorticosteroid injection
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).
Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Training
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Fonden for Faglig Udvikling af Speciallægepraksis, Denmark
UNKNOWN
Bispebjerg Hospital
OTHER
Responsible Party
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Finn Elkjær Johannsen
chief physician, MD, specialist in Rheumatology
Principal Investigators
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Michael Kjær, Professor
Role: STUDY_CHAIR
University of Copenhagen
Locations
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Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen, , Denmark
Countries
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References
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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.
Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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H-2-2012-150-FJ
Identifier Type: -
Identifier Source: org_study_id
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