Plantar Fasciitis
Conditions
Keywords
Plantar fasciitis, Treatment, Training, Glucocorticosteroid injection
Brief summary
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.
Detailed description
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.
Interventions
OTHERTraining
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
DRUGGlucocorticosteroid injection
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).
BEHAVIORALReduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Sponsors
Fonden for Faglig Udvikling af Speciallægepraksis, Denmark
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100 mm VAS score pain at function. Average pain during everyday living. | 6 month | — |
| Foot Function Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound scanning thickness measure | at entry, 3 month (after intervention), 6 month, 12 month, 24 month | measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning |
| Foot Function Index | 3 month, 12 month, 24 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. |
| 100 mm VAS score pain at function. Average pain during everyday living. | 3 months, 12 months, 24 months | — |
| 100 mm VAS score for morning pain | at entry, 3 month (after intervention), 6 month, 12 month, 24 month | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| patient diary | week 1,2,3,4,5,6,7,8,9,10,11,12,13 | 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. |
| Contrast Enhanced Ultrasound | at entry after 3-4 months and after 1 year | 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. |
Countries
Denmark
Outcome results
None listed