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

Phase 4
Completed
Conditions
Plantar Fasciitis
Interventions
Other: Training
Drug: Glucocorticosteroid injection
Behavioral: Reduction in impact
Registration Number
NCT01994759
Lead Sponsor
Bispebjerg Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TrainingTrainingstrengthening and stretching exercises.
TrainingReduction in impactstrengthening and stretching exercises.
Glucocorticosteroid injectionGlucocorticosteroid injectionInjection of 40 mg methylprednisolone.
Glucocorticosteroid injectionReduction in impactInjection of 40 mg methylprednisolone.
Training and Glucocorticosteroid injectionsTrainingA combination treatment of the two above.
Training and Glucocorticosteroid injectionsGlucocorticosteroid injectionA combination treatment of the two above.
Training and Glucocorticosteroid injectionsReduction in impactA combination treatment of the two above.
Primary Outcome Measures
NameTimeMethod
Foot Function Index6 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.6 month
Secondary Outcome Measures
NameTimeMethod
100 mm VAS score for morning painat entry, 3 month (after intervention), 6 month, 12 month, 24 month
Ultrasound scanning thickness measureat 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

100 mm VAS score pain at function. Average pain during everyday living.3 months, 12 months, 24 months
Foot Function Index3 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.

Trial Locations

Locations (1)

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

🇩🇰

Kobenhavn, Denmark

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