Plantar Fasciitis Clinical Trial
Official title:
Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.
Verified date | July 2018 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 1, 2016 |
Est. primary completion date | July 1, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Institute of Sports Medicine Copenhagen, Bispebjerg Hospital | Kobenhavn |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital | Fonden for Faglig Udvikling af Speciallægepraksis, Denmark |
Denmark,
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. — View Citation
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. — View Citation
Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. Review. Update in: Cochrane Database Syst Rev. 2010;(1):CD000416. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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Tobin L, Simonsen L, Bülow 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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | patient diary | 100 mm VAS score for morning pain (average in the week). 100 mm VAS score for pain at function (average in the week). Compliance to the treatment. Side effects to glucocorticosteroid injections is described. | week 1,2,3,4,5,6,7,8,9,10,11,12,13 | |
Other | Contrast Enhanced Ultrasound | For determining bloodflow of the plantar fascia we inject 2 ml SonoVue®. Ultrasound contrast agent, that amplifies the ultrasound signal. After injection we simultaneously ultrasound scan both feet for 3 minutes. The perfusion of the fascia can hereby bee calculated. Only patients with unilateral plantar fasciitis will bee offered this evaluation. |
at entry after 3-4 months and after 1 year | |
Primary | 100 mm VAS score pain at function. Average pain during everyday living. | 6 month | ||
Primary | 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 | 100 mm VAS score for morning pain | at entry, 3 month (after intervention), 6 month, 12 month, 24 month | ||
Secondary | Ultrasound scanning thickness measure | measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning | at entry, 3 month (after intervention), 6 month, 12 month, 24 month | |
Secondary | 100 mm VAS score pain at function. Average pain during everyday living. | 3 months, 12 months, 24 months | ||
Secondary | 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. | 3 month, 12 month, 24 month |
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