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

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Training
Glucocorticosteroid injection
Reduction in impact
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar fasciitis, Treatment, Training, Glucocorticosteroid injection

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Training

Glucocorticosteroid injection

Training and Glucocorticosteroid injections

Arm Description

strengthening and stretching exercises.

Injection of 40 mg methylprednisolone.

A combination treatment of the two above.

Outcomes

Primary Outcome Measures

100 mm VAS score pain at function. Average pain during everyday living.
Foot Function Index
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
Ultrasound scanning thickness measure
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.
Foot Function Index
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.

Full Information

First Posted
November 10, 2013
Last Updated
July 10, 2018
Sponsor
Bispebjerg Hospital
Collaborators
Fonden for Faglig Udvikling af Speciallægepraksis, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01994759
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Fonden for Faglig Udvikling af Speciallægepraksis, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar fasciitis, Treatment, Training, Glucocorticosteroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Active Comparator
Arm Description
strengthening and stretching exercises.
Arm Title
Glucocorticosteroid injection
Arm Type
Active Comparator
Arm Description
Injection of 40 mg methylprednisolone.
Arm Title
Training and Glucocorticosteroid injections
Arm Type
Active Comparator
Arm Description
A combination treatment of the two above.
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
Heavy slow resistance exercise, Eccentric training, stretching
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Glucocorticosteroid injection
Other Intervention Name(s)
Methylprednisolone, Depo-medrol
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Reduction in impact
Other Intervention Name(s)
Shock absorbtion
Intervention Description
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
Primary Outcome Measure Information:
Title
100 mm VAS score pain at function. Average pain during everyday living.
Time Frame
6 month
Title
Foot Function Index
Description
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
100 mm VAS score for morning pain
Time Frame
at entry, 3 month (after intervention), 6 month, 12 month, 24 month
Title
Ultrasound scanning thickness measure
Description
measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning
Time Frame
at entry, 3 month (after intervention), 6 month, 12 month, 24 month
Title
100 mm VAS score pain at function. Average pain during everyday living.
Time Frame
3 months, 12 months, 24 months
Title
Foot Function Index
Description
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.
Time Frame
3 month, 12 month, 24 month
Other Pre-specified Outcome Measures:
Title
patient diary
Description
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.
Time Frame
week 1,2,3,4,5,6,7,8,9,10,11,12,13
Title
Contrast Enhanced Ultrasound
Description
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.
Time Frame
at entry after 3-4 months and after 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kjær, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
City
Kobenhavn
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

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19345789
Citation
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derived

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

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