Plantar Fasciitis, Operation or Conservative Treatment

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Plantar Fasciitis

Treatments: Drug: methylprednisolon; Procedure: endoscopic surgery; Drug: lidokaine; Behavioral: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02448316

H-2-2012-151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

endoscopic surgery

Active Comparator group

Description:

Endoscopic operation through 2 portals profound for the fascia plantaris

Treatment:

Procedure: endoscopic surgery

conservative treatment

Active Comparator group

Description:

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).

Treatment:

Behavioral: Training

Drug: lidokaine

Drug: methylprednisolon