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Plantar Fasciitis, Operation or Conservative Treatment

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
endoscopic surgery
methylprednisolon
lidokaine
Training
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

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
  • ultrasound scanning at the first visit shows thickness of the proximal 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
  • long lasting 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.
  • patients 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 Type

Active Comparator

Active Comparator

Arm Label

endoscopic surgery

conservative treatment

Arm Description

Endoscopic operation through 2 portals profound for the fascia plantaris

The standard treatment here acting as controle treatment . All patients are informed to decrease activity level, use shoes with good shock absorption and are recommended to use insoles (standard orthoses) for increased shock absorption. Training is supervised every third week by a physiotherapist (week 1,3,6,9), and daily training is carried out at home. Glucocorticoid injections of 1 ml Glucocorticosteroid (methylprednisolon 40 mg) and 1 ml of Lidokaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris are given every month until the fascia thickness is below 4 mm (max 3 injections).

Outcomes

Primary Outcome Measures

Foot Function Index
Foot Function Index (FFI) is a validated score usefull for 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
Foot Function Index
Foot Function Index (FFI) is a validated score usefull for 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
100 mm VAS score for morning pain
100 mm VAS score for morning pain
100 mm VAS score for morning pain
100 mm VAS score for pain at function
100 mm VAS score for pain at function
100 mm VAS score for pain at function
100 mm VAS score for pain at function
single leg jumping length
Standing on the diseased leg, the patient jumps as far as possible landing on the same leg. the best of 3 trials.
positionel MR scanning (pMRI)
only for the operated patients the change in bone position in standing is measured using a pMRI, where bone position is measured in supine and standing before and 12 months after the operation. This will also include patients referred directly to operation and therefore not included in the RCT
Tantalum pearle-calcaneus distance
only for operated patients the distance from calcaneus to a Tantalum pearle inserted in the plantar fascia during operation is measured by lying and standing X-ray. This will also include patients referred directly to operation and therefore not included in the RCT
Foot Function Index
Foot Function Index (FFI) is a validated score usefull for 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
May 10, 2015
Last Updated
July 10, 2018
Sponsor
Bispebjerg Hospital
Collaborators
The Danish Rheumatism Association
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1. Study Identification

Unique Protocol Identification Number
NCT02448316
Brief Title
Plantar Fasciitis, Operation or Conservative Treatment
Official Title
Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
The Danish Rheumatism Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.
Detailed Description
Plantars 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 and in most clinics the standard treatment, despite the fact that a recent Cochrane review found limited evidence for treatment of plantar heelpain. Once the condition gets chronic the response to several kinds of treatment is less predictable. However it has been demonstrated that endoscopic surgery for plantar fasciitis using a deep-fascial approach was successful in individuals with an active sports anamnesis, and all patients returned with this treatment to full athletic activities within 8-15 weeks. This high succesrate is not seen in conservative treatment with decrease in activity, training and injections of glucocorticosteroid, eventhough they had shorter disease duration. Therefore the investigators think it would be interesting to offer this minimal invasive operation to patients much earlier in the disease, especially as there is no reported severe sideeffects . However, surgery is very seldom compared with results of other treatment modalities, and no randomized studies exist on the effect of operation vs the normal conservative standard-treatment. The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endoscopic surgery
Arm Type
Active Comparator
Arm Description
Endoscopic operation through 2 portals profound for the fascia plantaris
Arm Title
conservative treatment
Arm Type
Active Comparator
Arm Description
The standard treatment here acting as controle treatment . All patients are informed to decrease activity level, use shoes with good shock absorption and are recommended to use insoles (standard orthoses) for increased shock absorption. Training is supervised every third week by a physiotherapist (week 1,3,6,9), and daily training is carried out at home. Glucocorticoid injections of 1 ml Glucocorticosteroid (methylprednisolon 40 mg) and 1 ml of Lidokaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris are given every month until the fascia thickness is below 4 mm (max 3 injections).
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgery
Other Intervention Name(s)
Fascial release, Heel spur resection, Training
Intervention Description
Through 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus. A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion). Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days,
Intervention Type
Drug
Intervention Name(s)
methylprednisolon
Other Intervention Name(s)
Depo-medrol, Glucocorticosteroid injection
Intervention Description
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
Intervention Type
Drug
Intervention Name(s)
lidokaine
Other Intervention Name(s)
Xylocain
Intervention Description
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
Intervention Type
Behavioral
Intervention Name(s)
Training
Other Intervention Name(s)
strength training, stretching
Intervention Description
the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.
Primary Outcome Measure Information:
Title
Foot Function Index
Description
Foot Function Index (FFI) is a validated score usefull for 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 months
Title
Foot Function Index
Description
Foot Function Index (FFI) is a validated score usefull for 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
12 months
Secondary Outcome Measure Information:
Title
100 mm VAS score for morning pain
Time Frame
3 months
Title
100 mm VAS score for morning pain
Time Frame
6 months
Title
100 mm VAS score for morning pain
Time Frame
12 months
Title
100 mm VAS score for morning pain
Time Frame
24 months
Title
100 mm VAS score for pain at function
Time Frame
3 months
Title
100 mm VAS score for pain at function
Time Frame
6 months
Title
100 mm VAS score for pain at function
Time Frame
12 months
Title
100 mm VAS score for pain at function
Time Frame
24 months
Title
single leg jumping length
Description
Standing on the diseased leg, the patient jumps as far as possible landing on the same leg. the best of 3 trials.
Time Frame
12 months
Title
positionel MR scanning (pMRI)
Description
only for the operated patients the change in bone position in standing is measured using a pMRI, where bone position is measured in supine and standing before and 12 months after the operation. This will also include patients referred directly to operation and therefore not included in the RCT
Time Frame
12 months
Title
Tantalum pearle-calcaneus distance
Description
only for operated patients the distance from calcaneus to a Tantalum pearle inserted in the plantar fascia during operation is measured by lying and standing X-ray. This will also include patients referred directly to operation and therefore not included in the RCT
Time Frame
12 months
Title
Foot Function Index
Description
Foot Function Index (FFI) is a validated score usefull for 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
24 months

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 ultrasound scanning at the first visit shows thickness of the proximal 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 long lasting 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. patients 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
Finn MD Johannsen, MD
Organizational Affiliation
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
City
Kobenhavn
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19345789
Citation
Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):701-6. doi: 10.1016/j.apmr.2008.11.002.
Results Reference
background
PubMed Identifier
12917892
Citation
Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
Results Reference
background
PubMed Identifier
18524985
Citation
Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
Results Reference
background
PubMed Identifier
16353228
Citation
Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
Results Reference
background
PubMed Identifier
21655342
Citation
Uden H, Boesch E, Kumar S. Plantar fasciitis - to jab or to support? A systematic review of the current best evidence. J Multidiscip Healthc. 2011;4:155-64. doi: 10.2147/JMDH.S20053. Epub 2011 May 24.
Results Reference
background
PubMed Identifier
21704466
Citation
Komatsu F, Takao M, Innami K, Miyamoto W, Matsushita T. Endoscopic surgery for plantar fasciitis: application of a deep-fascial approach. Arthroscopy. 2011 Aug;27(8):1105-9. doi: 10.1016/j.arthro.2011.02.037. Epub 2011 Jun 24.
Results Reference
background
PubMed Identifier
17559761
Citation
Bazaz R, Ferkel RD. Results of endoscopic plantar fascia release. Foot Ankle Int. 2007 May;28(5):549-56. doi: 10.3113/FAI.2007.0549.
Results Reference
background
PubMed Identifier
15088083
Citation
Jerosch J, Schunck J, Liebsch D, Filler T. Indication, surgical technique and results of endoscopic fascial release in plantar fasciitis (E FRPF). Knee Surg Sports Traumatol Arthrosc. 2004 Sep;12(5):471-7. doi: 10.1007/s00167-004-0496-6. Epub 2004 Apr 14.
Results Reference
background
PubMed Identifier
19299346
Citation
Kalaci A, Cakici H, Hapa O, Yanat AN, Dogramaci Y, Sevinc TT. Treatment of plantar fasciitis using four different local injection modalities: a randomized prospective clinical trial. J Am Podiatr Med Assoc. 2009 Mar-Apr;99(2):108-13. doi: 10.7547/0980108.
Results Reference
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Plantar Fasciitis, Operation or Conservative Treatment

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