Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 100 mm VAS score pain at function. Average pain during everyday living.
研究概览
简要总结
The purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment.
详细描述
Plantar 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 with proven effect. However treatment of overuse injury in other tendon/aponeurosis-like structures, has over the later years been dominated by an increasing documentation of a good curative effect of heavy controlled mechanical loading (eccentric strength exercises or heavy slow concentric strength training) upon tendinopathies in Achilles or patella tendon. However, no studies have looked at the influence of physical training (e.g. strength training) on the diseased plantar aponeurosis. Also no studies have looked at the effect of a combination of giving local glucocorticoid injection and training on this or other tendon overuse entities.
We hypothesize that heavy strength training will have a positive effect upon PF, and that a combination of training and glucocorticoid injections will have an additive effect upon this disease and be even more effective than each of the treatments alone. Glucocorticoid injection acting as the standard control treatment.
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
- Single (Outcomes Assessor)
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.
- •Age 20-65 years
- •Ultrasound scanning at the first visit shows thickness of the 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
- •Longlasting 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
- •Patient 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
Training
strengthening and stretching exercises.
干预措施: Training (Other)
Training
strengthening and stretching exercises.
干预措施: Reduction in impact (Behavioral)
Glucocorticosteroid injection
Injection of 40 mg methylprednisolone.
干预措施: Glucocorticosteroid injection (Drug)
Glucocorticosteroid injection
Injection of 40 mg methylprednisolone.
干预措施: Reduction in impact (Behavioral)
Training and Glucocorticosteroid injections
A combination treatment of the two above.
干预措施: Training (Other)
Training and Glucocorticosteroid injections
A combination treatment of the two above.
干预措施: Glucocorticosteroid injection (Drug)
Training and Glucocorticosteroid injections
A combination treatment of the two above.
干预措施: Reduction in impact (Behavioral)
结局指标
主要结局
100 mm VAS score pain at function. Average pain during everyday living.
时间窗: 6 month
Foot Function Index
时间窗: 6 month
Foot function Index is a validated score for patients with 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(at entry, 3 month (after intervention), 6 month, 12 month, 24 month)
- Ultrasound scanning thickness measure(at entry, 3 month (after intervention), 6 month, 12 month, 24 month)
- 100 mm VAS score pain at function. Average pain during everyday living.(3 months, 12 months, 24 months)
- Foot Function Index(3 month, 12 month, 24 month)
研究者
Finn Elkjær Johannsen
chief physician, MD, specialist in Rheumatology
Bispebjerg Hospital
