Study Results
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Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2015-04-01
2017-11-01
Brief Summary
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Detailed Description
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Once the condition gets chronic the response to several kinds of treatment is less predictable. However it has been demonstrated that endoscopic surgery for plantar fasciitis using a deep-fascial approach was successful in individuals with an active sports anamnesis, and all patients returned with this treatment to full athletic activities within 8-15 weeks. This high succesrate is not seen in conservative treatment with decrease in activity, training and injections of glucocorticosteroid, eventhough they had shorter disease duration. Therefore the investigators think it would be interesting to offer this minimal invasive operation to patients much earlier in the disease, especially as there is no reported severe sideeffects .
However, surgery is very seldom compared with results of other treatment modalities, and no randomized studies exist on the effect of operation vs the normal conservative standard-treatment.
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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endoscopic surgery
Endoscopic operation through 2 portals profound for the fascia plantaris
endoscopic surgery
Through 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus.
A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion).
Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days,
conservative treatment
The standard treatment here acting as controle treatment . All patients are informed to decrease activity level, use shoes with good shock absorption and are recommended to use insoles (standard orthoses) for increased shock absorption. Training is supervised every third week by a physiotherapist (week 1,3,6,9), and daily training is carried out at home. Glucocorticoid injections of 1 ml Glucocorticosteroid (methylprednisolon 40 mg) and 1 ml of Lidokaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris are given every month until the fascia thickness is below 4 mm (max 3 injections).
methylprednisolon
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
lidokaine
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
Training
the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.
Interventions
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endoscopic surgery
Through 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus.
A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion).
Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days,
methylprednisolon
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
lidokaine
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
Training
the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.
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
* ultrasound scanning at the first visit shows thickness of the proximal fascia above 4 mm
* patient can read and understand danish
Exclusion Criteria
* leg ulcerations
* long lasting 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.
* patients 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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The Danish Rheumatism Association
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Finn Elkjær Johannsen
chief physician
Principal Investigators
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Finn MD Johannsen, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark
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.
Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
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.
Komatsu F, Takao M, Innami K, Miyamoto W, Matsushita T. Endoscopic surgery for plantar fasciitis: application of a deep-fascial approach. Arthroscopy. 2011 Aug;27(8):1105-9. doi: 10.1016/j.arthro.2011.02.037. Epub 2011 Jun 24.
Bazaz R, Ferkel RD. Results of endoscopic plantar fascia release. Foot Ankle Int. 2007 May;28(5):549-56. doi: 10.3113/FAI.2007.0549.
Jerosch J, Schunck J, Liebsch D, Filler T. Indication, surgical technique and results of endoscopic fascial release in plantar fasciitis (E FRPF). Knee Surg Sports Traumatol Arthrosc. 2004 Sep;12(5):471-7. doi: 10.1007/s00167-004-0496-6. Epub 2004 Apr 14.
Kalaci A, Cakici H, Hapa O, Yanat AN, Dogramaci Y, Sevinc TT. Treatment of plantar fasciitis using four different local injection modalities: a randomized prospective clinical trial. J Am Podiatr Med Assoc. 2009 Mar-Apr;99(2):108-13. doi: 10.7547/0980108.
Other Identifiers
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H-2-2012-151
Identifier Type: -
Identifier Source: org_study_id
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