Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT03367468
Status:
UNKNOWN
Last Update Posted:
2019-10-10
First Post:
2017-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Therapy Interventions in Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2017-11-10', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception of pain', 'timeFrame': '6 weeks', 'description': 'Perception of pain with Visual Analog Scale (VAS) with palpation, first steps in the morning and after long walk.\n\nThe Visual Analog Scale is a valid and reliable measure of pain intensity. To rate pain intensity a mark is placed on a 100-mm VAS. The VAS is horizontally positioned with the extremes labeled\'\'least possible pain\'\' and \'\'worst possible pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Subjects will be asked to rate pain in three different conditions as palpation, first steps in the morning and after long walk.'}], 'secondaryOutcomes': [{'measure': 'Perception of quality of life', 'timeFrame': '6 weeks', 'description': 'The World Health Organization (WHO) Quality of Life - Bref Questionnaire is a 26-item self-administered instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher score presents better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plantar fascitis', 'Pain', 'Exercise', 'Physiotherapy', 'Quality of life'], 'conditions': ['Plantar Fascitis', 'Pain']}, 'referencesModule': {'references': [{'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': '21916393', 'type': 'BACKGROUND', 'citation': 'Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.'}, {'pmid': '24867905', 'type': 'BACKGROUND', 'citation': 'Podolsky R, Kalichman L. Taping for plantar fasciitis. J Back Musculoskelet Rehabil. 2015;28(1):1-6. doi: 10.3233/BMR-140485.'}, {'pmid': '20439021', 'type': 'BACKGROUND', 'citation': 'Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouche R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010 May-Jun;49(3 Suppl):S1-19. doi: 10.1053/j.jfas.2010.01.001.'}, {'pmid': '25361863', 'type': 'BACKGROUND', 'citation': 'Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.'}, {'pmid': '16882901', 'type': 'BACKGROUND', 'citation': 'Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.'}, {'pmid': '21703003', 'type': 'BACKGROUND', 'citation': 'Sweeting D, Parish B, Hooper L, Chester R. The effectiveness of manual stretching in the treatment of plantar heel pain: a systematic review. J Foot Ankle Res. 2011 Jun 25;4:19. doi: 10.1186/1757-1146-4-19.'}, {'pmid': '26655866', 'type': 'BACKGROUND', 'citation': 'Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.'}, {'pmid': '24567688', 'type': 'BACKGROUND', 'citation': 'Moon DC, Kim K, Lee SK. Immediate Effect of Short-foot Exercise on Dynamic Balance of Subjects with Excessively Pronated Feet. J Phys Ther Sci. 2014 Jan;26(1):117-9. doi: 10.1589/jpts.26.117. Epub 2014 Feb 6.'}, {'pmid': '25818718', 'type': 'BACKGROUND', 'citation': 'McKeon PO, Fourchet F. Freeing the foot: integrating the foot core system into rehabilitation for lower extremity injuries. Clin Sports Med. 2015 Apr;34(2):347-61. doi: 10.1016/j.csm.2014.12.002. Epub 2015 Jan 24.'}, {'pmid': '9770933', 'type': 'BACKGROUND', 'citation': 'Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.'}]}, 'descriptionModule': {'briefSummary': 'Plantar fasciitis is seen common in clinics and responsible from most of foot related pain problems. There are many treatment modalities in the literature as well as there is no golden standard to treat plantar fasciitis in non-surgical ways. The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.', 'detailedDescription': 'Plantar fasciitis is frequently seen in adult population as a pain related problem of the foot. Pain, as a most prominent symptom, is caused from repetitive microtraumas and inflammation where plantar fascia attaches to the calcaneus. Pain starts from heel pad or medial tubercule of the calcaneus and spreads through plantar fascia and medial longitudinal arch.\n\nObesity, increased foot pronation, difference in extremity length, long standing duration and Achilles tendon tightness are some of the factors which stress plantar fascia and sometimes cause degenerative changes on it. Weakness of intrinsic muscle is also another factor which is thought to be related with plantar fasciitis.\n\nDiagnosis is mostly depends on history and physical examination. First steps in the morning, walking after long rest, and palpation of medial tubercule of calcaneus are painful.\n\nAccording to the literature, non-surgical treatment modalities relieve symptoms of patients successfully. Orthotics, night splints, manipulation interventions with conventional methods are effective to decrease pain and improve function. There are various physiotherapy treatment approaches in plantar fasciitis but there is no consensus about most effective treatment program. Stretching of plantar flexor muscles and plantar fascia is one of the core elements of the treatment plan. Strengthening exercises together with stretching were shown more effective than only stretching. Foot orthoses are thought to prevent increased pronation and relieving stress on plantar fascia in patients with plantar fasciitis. Usage of insoles with night splints is found more effective. Taping is also helpful to acute pain control. Short foot exercises as isolated intrinsic foot muscles strengthening helps to providing subtalar foot position and supports plantar fascia and foot arches. Manual techniques improve lower extremity joint mobility and decreases related pain. Extracorporeal Shock Wave Therapy is suggested to try after at least six month ineffective conservative treatments. If symptoms resist more than six months and non-conservative treatments are found ineffective, invasive approaches as steroid injections are applicable.\n\nTreatment of this common problem in population is important to ensure patients returning in earliest period to daily life with full physical capacity. There are many conservative options to treat plantar fasciitis but best treatment program combination was not clear The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOlder than 18 years, Baseline Roles and Maudsley score \\> 2, Accepting and signing consent form Daily usage of insoles which was prescribed by doctor No history of systemic disease and surgery that affects foot biomechanics No history of cognitive, mental, neurological or psychological problems.\n\nExclusion Criteria:\n\nPresence of chronic or active infection in treatment site, Not accepting to participate in the study Systemic, neurologic, rheumatologic,and vascular disease history, Pregnancy, BMI \\> 35 kg/m2, History of foot and/or ankle surgery.'}, 'identificationModule': {'nctId': 'NCT03367468', 'briefTitle': 'Conservative Therapy Interventions in Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Comparison of the Different Conservative Therapy Interventions in Plantar Fasciitis', 'orgStudyIdInfo': {'id': '06144834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy group', 'description': 'Strengthening and stretching exercises,cross friction massage (supervised by physiotherapist) Mobilization techniques Daily usage of prescribed orthotic insole', 'interventionNames': ['Other: Exercise', 'Other: Mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home exercise group', 'description': 'Strenthening and stretching exercises Daily usage of prescribed orthotic insole', 'interventionNames': ['Other: Mobilization']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Follow ups Daily usage of prescribed orthotic insole'}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Strengthening exercises ( extrinsic and intrinsic foot muscles) Stretcthing exercises (plantar fascia, plantar flexor muscles)', 'armGroupLabels': ['Physiotherapy group']}, {'name': 'Mobilization', 'type': 'OTHER', 'description': 'Antero-posterior gliding, talocrural traction, metatarsal mobilization', 'armGroupLabels': ['Home exercise group', 'Physiotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sulenur YILDIZ, PT, MSc', 'role': 'CONTACT', 'email': 'sulenur.subasi@hacettepe.edu.tr'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Sulenur YILDIZ, PT, MSc', 'role': 'CONTACT', 'email': 'sulenur.subasi@hacettepe.edu.tr', 'phone': '+903123051576', 'phoneExt': '139'}, {'name': 'Nilgun BEK, PT, PhD, Professor', 'role': 'CONTACT', 'email': 'nilgunbek@gmail.com'}], 'overallOfficials': [{'name': 'Nilgun BEK, PT, PhD, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sulenur Yildiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Sulenur Yildiz', 'investigatorAffiliation': 'Hacettepe University'}}}}