NCT02448316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 11, 2018

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

May 10, 2015

Last Update Submit

July 10, 2018

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (2)

  • 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

    6 months

  • 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

    12 months

Secondary Outcomes (12)

  • 100 mm VAS score for morning pain

    3 months

  • 100 mm VAS score for morning pain

    6 months

  • 100 mm VAS score for morning pain

    12 months

  • 100 mm VAS score for morning pain

    24 months

  • 100 mm VAS score for pain at function

    3 months

  • +7 more secondary outcomes

Study Arms (2)

endoscopic surgery

ACTIVE COMPARATOR

Endoscopic operation through 2 portals profound for the fascia plantaris

Procedure: endoscopic surgery

conservative treatment

ACTIVE COMPARATOR

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).

Drug: methylprednisolonDrug: lidokaineBehavioral: Training

Interventions

endoscopic surgeryPROCEDURE

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,

Also known as: Fascial release, Heel spur resection, Training
endoscopic surgery
methylprednisolonDRUG

1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible

Also known as: Depo-medrol, Glucocorticosteroid injection
conservative treatment
lidokaineDRUG

1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible

Also known as: Xylocain
conservative treatment
TrainingBEHAVIORAL

the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.

Also known as: strength training, stretching
conservative treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 19345789BACKGROUND

  • Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.

    PMID: 12917892BACKGROUND

  • 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.

    PMID: 18524985BACKGROUND

  • 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.

    PMID: 16353228BACKGROUND

  • 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.

    PMID: 21655342BACKGROUND

  • 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.

    PMID: 21704466BACKGROUND

  • 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.

    PMID: 17559761BACKGROUND

  • 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.

    PMID: 15088083BACKGROUND

  • 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.

    PMID: 19299346BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

EndoscopyMethylprednisoloneMethylprednisolone AcetateResistance Training

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Finn MD Johannsen, MD

    Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 19, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2017

Last Updated

July 11, 2018

Record last verified: 2017-03

Locations

DK(1)