A Phase 4 interventional study of Training and Glucocorticosteroid injection in Plantar Fasciitis, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Bispebjerg Hospital · Phase 4, Interventional, and Treatment
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.
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.
235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.
This study's enrollment of 90 is above the median of 54 across 192 interventional studies indexed under Fasciitis.
Browse Fasciitis studies →Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
strengthening and stretching exercises.
Other: Training · Behavioral: Reduction in impact
Injection of 40 mg methylprednisolone.
Drug: Glucocorticosteroid injection · Behavioral: Reduction in impact
A combination treatment of the two above.
Other: Training · Drug: Glucocorticosteroid injection · Behavioral: Reduction in impact
Patients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly
Also known as: Heavy slow resistance exercise, Eccentric training, stretching
Ultra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris. Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections).
Also known as: Methylprednisolone, Depo-medrol
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Also known as: Shock absorbtion
100 mm VAS score pain at function. Average pain during everyday living.
Time frame: 6 month
Foot Function Index
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.
Time frame: 6 month
100 mm VAS score for morning pain
Time frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
Ultrasound scanning thickness measure
measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning
Time frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
100 mm VAS score pain at function. Average pain during everyday living.
Time frame: 3 months, 12 months, 24 months
Foot Function Index
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.
Time frame: 3 month, 12 month, 24 month
patient diary
100 mm VAS score for morning pain (average in the week). 100 mm VAS score for pain at function (average in the week). Compliance to the treatment. Side effects to glucocorticosteroid injections is described.
Time frame: week 1,2,3,4,5,6,7,8,9,10,11,12,13
Contrast Enhanced Ultrasound
For determining bloodflow of the plantar fascia we inject 2 ml SonoVue®. Ultrasound contrast agent, that amplifies the ultrasound signal. After injection we simultaneously ultrasound scan both feet for 3 minutes. The perfusion of the fascia can hereby bee calculated. Only patients with unilateral plantar fasciitis will bee offered this evaluation.
Time frame: at entry after 3-4 months and after 1 year
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Bispebjerg Hospital