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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bispebjerg Hospital
Sponsor:
Collaborator:
Fonden for Faglig Udvikling af Speciallægepraksis
Information provided by (Responsible Party):
Finn Elkjær Johannsen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01994759
First received: November 10, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Plantar Fasciitis
Other: Training
Drug: Glucocorticosteroid injection
Behavioral: Reduction in impact
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • 100 mm VAS score pain at function. Average pain during everyday living. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Foot Function Index [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 100 mm VAS score for morning pain [ Time Frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month ] [ Designated as safety issue: No ]
  • Ultrasound scanning thickness measure [ Time Frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Foot Function Index [ Time Frame: 3 month, 12 month, 24 month ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • patient diary [ Time Frame: week 1,2,3,4,5,6,7,8,9,10,11,12,13 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at entry after 3-4 months and after 1 year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Heavy slow resistance exercise
  • Eccentric training
  • stretching
Behavioral: Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Other Name: Shock absorbtion
Active Comparator: Glucocorticosteroid injection
Injection of 40 mg methylprednisolone.
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:
  • Methylprednisolone
  • Depo-medrol
Behavioral: Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Other Name: Shock absorbtion
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:
  • Heavy slow resistance exercise
  • Eccentric training
  • stretching
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:
  • Methylprednisolone
  • Depo-medrol
Behavioral: Reduction in impact
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Other Name: Shock absorbtion

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994759

Contacts
Contact: Finn E Johannsen, MD 004531671057 f.e.johannsen@dadlnet.dk

Locations
Denmark
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Recruiting
Kobenhavn, Denmark, 2400
Contact: Finn E Johannsen, MD    004531671057    f.e.johannsen@dadlnet.dk   
Sub-Investigator: Jessica Pingel, PhD         
Sub-Investigator: Rasmus Bechshoeft, MD         
Sub-Investigator: Nikolaj Malmgaard-Clausen, stud.med.         
Sub-Investigator: Robert Herzog, PT         
Principal Investigator: Michael Kjær, Professor         
Sub-Investigator: Rikke Broholm, MD         
Sub-Investigator: Lene Rørdam, MD, DMSc         
Sub-Investigator: Jens J Bülow, Professor         
Sponsors and Collaborators
Bispebjerg Hospital
Fonden for Faglig Udvikling af Speciallægepraksis
Investigators
Study Chair: Michael Kjær, Professor University of Copenhagen
  More Information

Publications:

Responsible Party: Finn Elkjær Johannsen, chief physician, MD, specialist in Rheumatology, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01994759     History of Changes
Other Study ID Numbers: H-2-2012-150-FJ
Study First Received: November 10, 2013
Last Updated: November 21, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:
Plantar fasciitis
Treatment
Training
Glucocorticosteroid injection

Additional relevant MeSH terms:
Fasciitis, Plantar
Fasciitis
Foot Diseases
Musculoskeletal Diseases
Glucocorticoids
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014