Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Plantar Fasciitis

Treatments: Other: Training; Drug: Glucocorticosteroid injection; Behavioral: Reduction in impact

Study type: Interventional

Funder types: Other

Identifiers

NCT01994759

H-2-2012-150-FJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Training

Active Comparator group

Description:

strengthening and stretching exercises.

Treatment:

Behavioral: Reduction in impact

Other: Training

Glucocorticosteroid injection

Active Comparator group

Description:

Injection of 40 mg methylprednisolone.

Treatment:

Behavioral: Reduction in impact

Drug: Glucocorticosteroid injection

Training and Glucocorticosteroid injections

Active Comparator group

Description:

A combination treatment of the two above.

Treatment:

Behavioral: Reduction in impact

Drug: Glucocorticosteroid injection

Other: Training