Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Foot Function Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
endoscopic surgery
Endoscopic operation through 2 portals profound for the fascia plantaris
干预措施: endoscopic surgery (Procedure)
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).
干预措施: methylprednisolon (Drug)
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).
干预措施: lidokaine (Drug)
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).
干预措施: Training (Behavioral)
结局指标
主要结局
Foot Function Index
时间窗: 12 months
Foot Function Index (FFI) is a validated score usefull for 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
次要结局
- 100 mm VAS score for morning pain(24 months)
- 100 mm VAS score for pain at function(24 months)
- Tantalum pearle-calcaneus distance(12 months)
- single leg jumping length(12 months)
- positionel MR scanning (pMRI)(12 months)
- Foot Function Index(24 months)
研究者
Finn Elkjær Johannsen
chief physician
Bispebjerg Hospital