Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-04-17 @ 7:09 AM
Study NCT ID:
NCT01994759
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2013-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2013-11-10', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'patient diary', 'timeFrame': 'week 1,2,3,4,5,6,7,8,9,10,11,12,13', '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.'}, {'measure': 'Contrast Enhanced Ultrasound', 'timeFrame': 'at entry after 3-4 months and after 1 year', '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.\n\nOnly patients with unilateral plantar fasciitis will bee offered this evaluation.'}], 'primaryOutcomes': [{'measure': '100 mm VAS score pain at function. Average pain during everyday living.', 'timeFrame': '6 month'}, {'measure': 'Foot Function Index', 'timeFrame': '6 month', '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.'}], 'secondaryOutcomes': [{'measure': '100 mm VAS score for morning pain', 'timeFrame': 'at entry, 3 month (after intervention), 6 month, 12 month, 24 month'}, {'measure': 'Ultrasound scanning thickness measure', 'timeFrame': 'at entry, 3 month (after intervention), 6 month, 12 month, 24 month', 'description': 'measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning'}, {'measure': '100 mm VAS score pain at function. Average pain during everyday living.', 'timeFrame': '3 months, 12 months, 24 months'}, {'measure': 'Foot Function Index', 'timeFrame': '3 month, 12 month, 24 month', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plantar fasciitis', 'Treatment', 'Training', 'Glucocorticosteroid injection'], 'conditions': ['Plantar Fasciitis']}, 'referencesModule': {'references': [{'pmid': '19345789', 'type': 'BACKGROUND', '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.'}, {'pmid': '12917892', 'type': 'BACKGROUND', 'citation': 'Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.'}, {'pmid': '21655342', 'type': 'BACKGROUND', '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.'}, {'pmid': '12237265', 'type': 'BACKGROUND', 'citation': 'Vohra PK, Kincaid BR, Japour CJ, Sobel E. Ultrasonographic evaluation of plantar fascia bands. A retrospective study of 211 symptomatic feet. J Am Podiatr Med Assoc. 2002 Sep;92(8):444-9. doi: 10.7547/87507315-92-8-444.'}, {'pmid': '20731685', 'type': 'BACKGROUND', 'citation': 'Tobin L, Simonsen L, Bulow J. Real-time contrast-enhanced ultrasound determination of microvascular blood volume in abdominal subcutaneous adipose tissue in man. Evidence for adipose tissue capillary recruitment. Clin Physiol Funct Imaging. 2010 Nov;30(6):447-52. doi: 10.1111/j.1475-097X.2010.00964.x. Epub 2010 Aug 22.'}, {'pmid': '16919213', 'type': 'BACKGROUND', 'citation': 'Roos E, Engstrom M, Soderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle Int. 2006 Aug;27(8):606-11. doi: 10.1177/107110070602700807.'}, {'pmid': '16895612', 'type': 'BACKGROUND', 'citation': 'Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2006 Aug 9;7:64. doi: 10.1186/1471-2474-7-64.'}, {'pmid': '10229276', 'type': 'BACKGROUND', 'citation': 'Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.'}, {'pmid': '19793213', 'type': 'BACKGROUND', 'citation': 'Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, Kaldau NC, Kjaer M, Magnusson SP. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009 Dec;19(6):790-802. doi: 10.1111/j.1600-0838.2009.00949.x. Epub 2009 May 28.'}, {'pmid': '22109854', 'type': 'BACKGROUND', 'citation': 'Cheng JW, Tsai WC, Yu TY, Huang KY. Reproducibility of sonographic measurement of thickness and echogenicity of the plantar fascia. J Clin Ultrasound. 2012 Jan;40(1):14-9. doi: 10.1002/jcu.20903. Epub 2011 Nov 22.'}, {'pmid': '30443664', 'type': 'DERIVED', 'citation': 'Johannsen FE, Herzog RB, Malmgaard-Clausen NM, Hoegberget-Kalisz M, Magnusson SP, Kjaer M. Corticosteroid injection is the best treatment in plantar fasciitis if combined with controlled training. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):5-12. doi: 10.1007/s00167-018-5234-6. Epub 2018 Nov 15.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOrthosis 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain at the medial attachment of fascia plantaris.\n* First step pain in the morning\n* Symptoms for at least 3 months.\n* Age 20-65 years\n* Ultrasound scanning at the first visit shows thickness of the fascia above 4 mm.\n* Patient can read and understand danish\n\nExclusion Criteria:\n\n* known arthritis, inflammatory bowl disease, psoriasis or clinical signs of any of these\n* Leg ulcerations\n* Longlasting oedema of the leg and foot\n* Palpatory decreased puls in the foot\n* Diabetes\n* Reduced sensibility in the foot\n* Infections in the foot\n* Daily use of pain killers\n* Pregnancy or planning to become pregnant\n* Earlier operations on the foot, that is judged to complicate training\n* Patient assessed not to be able to participate in the training for other reasons\n* Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT01994759', 'briefTitle': 'Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.', 'orgStudyIdInfo': {'id': 'H-2-2012-150-FJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Training', 'description': 'strengthening and stretching exercises.', 'interventionNames': ['Other: Training', 'Behavioral: Reduction in impact']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucocorticosteroid injection', 'description': 'Injection of 40 mg methylprednisolone.', 'interventionNames': ['Drug: Glucocorticosteroid injection', 'Behavioral: Reduction in impact']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Training and Glucocorticosteroid injections', 'description': 'A combination treatment of the two above.', 'interventionNames': ['Other: Training', 'Drug: Glucocorticosteroid injection', 'Behavioral: Reduction in impact']}], 'interventions': [{'name': 'Training', 'type': 'OTHER', 'otherNames': ['Heavy slow resistance exercise', 'Eccentric training', 'stretching'], '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', 'armGroupLabels': ['Training', 'Training and Glucocorticosteroid injections']}, {'name': 'Glucocorticosteroid injection', 'type': 'DRUG', 'otherNames': ['Methylprednisolone', 'Depo-medrol'], '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.\n\nGlucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections).', 'armGroupLabels': ['Glucocorticosteroid injection', 'Training and Glucocorticosteroid injections']}, {'name': 'Reduction in impact', 'type': 'BEHAVIORAL', 'otherNames': ['Shock absorbtion'], 'description': 'advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.', 'armGroupLabels': ['Glucocorticosteroid injection', 'Training', 'Training and Glucocorticosteroid injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Michael Kjær, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonden for Faglig Udvikling af Speciallægepraksis, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician, MD, specialist in Rheumatology', 'investigatorFullName': 'Finn Elkjær Johannsen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}