Plantar Fasciitis, Operation or Conservative Treatment

Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Procedure: endoscopic surgery; Drug: methylprednisolon; Drug: lidokaine; Behavioral: Training

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: endoscopic surgery; Endoscopic operation through 2 portals profound for the fascia plantaris	Procedure: endoscopic surgery; 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,; Other Names: Training; Fascial release; Heel spur resection
Active Comparator: conservative treatment; 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: methylprednisolon; 1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible; Other Names: Depo-medrol; Glucocorticosteroid injection; Drug: lidokaine; 1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible; Other Names: Xylocain; Behavioral: Training; the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.; Other Names: strength training; stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
100 mm VAS score for pain at function		6 months
100 mm VAS score for pain at function		12 months
100 mm VAS score for pain at function		24 months
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.	12 months
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	12 months
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	12 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	24 months

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: The Danish Rheumatism Association
• Investigators: Principal Investigator: Finn MD Johannsen, MD, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: May 10, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: H-2-2012-151