Plantar Fasciitis, Operation or Conservative Treatment
Ключові слова
Анотація
Опис
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.
Дати
| Востаннє перевірено: | 02/28/2017 |
| Перший поданий: | 05/09/2015 |
| Орієнтовна реєстрація подана: | 05/14/2015 |
| Опубліковано вперше: | 05/18/2015 |
| Останнє оновлення надіслано: | 07/09/2018 |
| Останнє оновлення опубліковано: | 07/10/2018 |
| Фактична дата початку навчання: | 03/31/2015 |
| Розрахункова дата первинного завершення: | 10/31/2016 |
| Розрахункова дата завершення дослідження: | 10/31/2017 |
Стан або захворювання
Втручання / лікування
Procedure: endoscopic surgery
Drug: conservative treatment
Drug: conservative treatment
Behavioral: conservative treatment
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Active Comparator: endoscopic surgery Endoscopic operation through 2 portals profound for the fascia plantaris | Procedure: 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, |
| Active Comparator: 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). | Drug: conservative treatment 1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible |
Критерії прийнятності
| Вік, придатний для навчання | 20 Years До 20 Years |
| Стать, яка підходить для вивчення | All |
| Приймає здорових добровольців | Так |
| Критерії | 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 |
Результат
Заходи первинного результату
1. Foot Function Index [6 months]
2. Foot Function Index [12 months]
Заходи вторинного результату
1. 100 mm VAS score for morning pain [3 months]
2. 100 mm VAS score for morning pain [6 months]
3. 100 mm VAS score for morning pain [12 months]
4. 100 mm VAS score for morning pain [24 months]
5. 100 mm VAS score for pain at function [3 months]
6. 100 mm VAS score for pain at function [6 months]
7. 100 mm VAS score for pain at function [12 months]
8. 100 mm VAS score for pain at function [24 months]
9. single leg jumping length [12 months]
10. positionel MR scanning (pMRI) [12 months]
11. Tantalum pearle-calcaneus distance [12 months]
12. Foot Function Index [24 months]
