Clinical trial NCT01994759: Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.
Official title: Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plantar Fasciitis
Keywords: Plantar fasciitis
Treatment
Training
Glucocorticosteroid injection
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Fonden for Faglig Udvikling af Speciallægepraksis, Denmark
First posted: 2013-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 100 mm VAS score pain at function. Average pain during everyday living.
timeFrame: 6 month
measure: Foot Function Index
timeFrame: 6 month
Secondary outcomes:
measure: 100 mm VAS score for morning pain
timeFrame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
measure: Ultrasound scanning thickness measure
timeFrame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
measure: 100 mm VAS score pain at function. Average pain during everyday living.
timeFrame: 3 months, 12 months, 24 months
measure: Foot Function Index
timeFrame: 3 month, 12 month, 24 month
Other outcomes:
measure: patient diary
timeFrame: week 1,2,3,4,5,6,7,8,9,10,11,12,13
measure: Contrast Enhanced Ultrasound
timeFrame: at entry after 3-4 months and after 1 year
Locations:
city: Kobenhavn
country: Denmark
facility: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Study officials:
affiliation: University of Copenhagen
name: Michael Kjær, Professor
role: STUDY_CHAIR
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