Clinical trial NCT02448316: Plantar Fasciitis, Operation or Conservative Treatment
Official title: Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plantar Fasciitis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
First posted: 2015-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Plantars fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development ( Orthosis and glucocorticoid injections are 2 widely used treatments and in most clinics the standard treatment, despite the fact that a recent Cochrane review found limited evidence for treatment of plantar heelpain.

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.

Eligibility criteria: Inclusion Criteria:

* pain at the medial attachment of fascia plantaris
* 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:

* known arthritis inflammatory bowl disease, psoriasis or clinical signs of any of these.
* 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

Primary outcomes:
measure: Foot Function Index
timeFrame: 6 months
measure: Foot Function Index
timeFrame: 12 months
Secondary outcomes:
measure: 100 mm VAS score for morning pain
timeFrame: 3 months
measure: 100 mm VAS score for morning pain
timeFrame: 6 months
measure: 100 mm VAS score for morning pain
timeFrame: 12 months
measure: 100 mm VAS score for morning pain
timeFrame: 24 months
measure: 100 mm VAS score for pain at function
timeFrame: 3 months
measure: 100 mm VAS score for pain at function
timeFrame: 6 months
measure: 100 mm VAS score for pain at function
timeFrame: 12 months
measure: 100 mm VAS score for pain at function
timeFrame: 24 months
measure: single leg jumping length
timeFrame: 12 months
measure: positionel MR scanning (pMRI)
timeFrame: 12 months
measure: Tantalum pearle-calcaneus distance
timeFrame: 12 months
measure: Foot Function Index
timeFrame: 24 months
Other outcomes:
Locations:
city: Kobenhavn
country: Denmark
facility: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark
name: Finn MD Johannsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.