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

July 10, 2018 updated by: Finn Elkjær Johannsen, Bispebjerg Hospital

Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kobenhavn, Denmark, 2400
        • Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training
strengthening and stretching exercises.
Other: Training
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
Other Names:
  • stretching
  • Heavy slow resistance exercise
  • Eccentric training
Behavioral: Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Other Names:
  • Shock absorbtion
Active Comparator: Glucocorticosteroid injection
Injection of 40 mg methylprednisolone.
Behavioral: Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Other Names:
  • Shock absorbtion
Drug: Glucocorticosteroid 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).

Other Names:
  • Depo-medrol
  • Methylprednisolone
Active Comparator: Training and Glucocorticosteroid injections
A combination treatment of the two above.
Other: Training
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
Other Names:
  • stretching
  • Heavy slow resistance exercise
  • Eccentric training
Behavioral: Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Other Names:
  • Shock absorbtion
Drug: Glucocorticosteroid 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).

Other Names:
  • Depo-medrol
  • Methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100 mm VAS score pain at function. Average pain during everyday living.
Time Frame: 6 month
6 month
Foot Function Index
Time Frame: 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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100 mm VAS score for morning pain
Time Frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
at entry, 3 month (after intervention), 6 month, 12 month, 24 month
Ultrasound scanning thickness measure
Time Frame: 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
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
3 months, 12 months, 24 months
Foot Function Index
Time Frame: 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.
3 month, 12 month, 24 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient diary
Time Frame: 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.
week 1,2,3,4,5,6,7,8,9,10,11,12,13
Contrast Enhanced Ultrasound
Time Frame: 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.
at entry after 3-4 months and after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Fonden for Faglig Udvikling af Speciallægepraksis, Denmark

Investigators

  • Study Chair: Michael Kjær, Professor, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2012-150-FJ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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