Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-04-17 @ 10:46 PM
Study NCT ID:
NCT02624635
Status:
TERMINATED
Last Update Posted:
2018-03-14
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip Strengthening and Manual Therapy for Heel Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Because of the lack of personnel and the recruitment failure of participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of intensity of pain', 'timeFrame': 'Up to three months', 'description': 'Level of intensity of pain assessed through the numerical pain scale.'}], 'secondaryOutcomes': [{'measure': 'Functional Status', 'timeFrame': 'Up to three months', 'description': 'Level of disability of the lower limb assessed through Lower Extremity Functional Scale.'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'Up to three months', 'description': 'Pressure pain threshold assessed through the algometer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Manual Therapy', 'Pain', 'Hip', 'Muscle Strength'], 'conditions': ['Plantar Fasciitis']}, 'referencesModule': {'references': [{'pmid': '9498581', 'type': 'BACKGROUND', 'citation': 'Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot Ankle Int. 1998 Feb;19(2):91-7. doi: 10.1177/107110079801900207.'}, {'pmid': '24703512', 'type': 'BACKGROUND', 'citation': 'Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.'}, {'pmid': '20627575', 'type': 'BACKGROUND', 'citation': 'Moore AR, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S, McQuay H; ACTINPAIN writing group of the IASP Special Interest Group (SIG) on Systematic Reviews in Pain Relief and the Cochrane Pain, Palliative and Supportive Care Systematic Review Group editors. "Evidence" in chronic pain--establishing best practice in the reporting of systematic reviews. Pain. 2010 Sep;150(3):386-389. doi: 10.1016/j.pain.2010.05.011. Epub 2010 Jun 2. No abstract available.'}, {'pmid': '16141740', 'type': 'BACKGROUND', 'citation': 'Babcock MS, Foster L, Pasquina P, Jabbari B. Treatment of pain attributed to plantar fasciitis with botulinum toxin a: a short-term, randomized, placebo-controlled, double-blind study. Am J Phys Med Rehabil. 2005 Sep;84(9):649-54. doi: 10.1097/01.phm.0000176339.73591.d7.'}, {'pmid': '2189536', 'type': 'BACKGROUND', 'citation': 'Bergmann JN. History and mechanical control of heel spur pain. Clin Podiatr Med Surg. 1990 Apr;7(2):243-59.'}, {'pmid': '10201543', 'type': 'BACKGROUND', 'citation': 'Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.'}, {'pmid': '12219661', 'type': 'BACKGROUND', 'citation': 'Buch M, Knorr U, Fleming L, Theodore G, Amendola A, Bachmann C, Zingas C, Siebert WE. [Extracorporeal shockwave therapy in symptomatic heel spurs. An overview]. Orthopade. 2002 Jul;31(7):637-44. doi: 10.1007/s00132-002-0323-z. German.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of manual therapy and of manual therapy associated with hip strengthening in the recovery of patients with heel pain.\n\nHeel pain decreases function, balance, walking and can cause change in the movement pattern. This alterations can induce a deficit in motor control of other structures as knee and hip. There is an importance to compare the effects of manual therapy and manual therapy associated with hip strengthening on the recover of patients with heel pain.', 'detailedDescription': 'After the initial assessment and data collection, participants will be randomly assigned to one of two intervention groups. Randomization will be held electronically in http://graphpad.com/quickcalcs/index.cfm site by simple random sampling. Patients will be treated for a maximum of 10 sessions, each session lasting about 40 minutes and each week two sessions. The maximum duration of treatment is 3 months. A physical therapist will be responsible for the screening of eligible patients and the random allocation of participants A second professional will be responsible for physical therapy initial and final evaluation and will be blind to the interventions. A third physical therapist will perform the interventions. The physiotherapist in charge of intervention will be blind to the initial and final evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with heel pain, that increases on the first steps after a period without activity and with long periods on standing position, regardless of age and gender and that didn't went under any physiotherapeutic treatment in the last 3 months.\n\nExclusion Criteria:\n\n* Patients who have a history of surgery on the lower limb on the past 6 months; patients with bilateral heel pain; patients under psychiatric treatment; patients that went under a manual therapy scheme treatment for heel pain before; rheumatic syndromes; patients who receive some benefit labor or patients underage."}, 'identificationModule': {'nctId': 'NCT02624635', 'briefTitle': 'Hip Strengthening and Manual Therapy for Heel Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitário Augusto Motta'}, 'officialTitle': 'Effects of Adding Hip Strengthening to Manual Therapy for Heel Pain Patients', 'orgStudyIdInfo': {'id': 'U1111-1174-3946'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Therapy', 'description': 'The treatment for this group will be manual therapy.', 'interventionNames': ['Other: Manual Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Therapy and Hip Strengthening', 'description': 'It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip.', 'interventionNames': ['Other: Manual Therapy and Hip Strengthening']}], 'interventions': [{'name': 'Manual Therapy', 'type': 'OTHER', 'description': 'The scheme established for that intervention is as follows: joint manipulation passive ankle and foot, myofascial release technique (gastrocnemius, soleus muscle and plantar fascia), neural mobilization (nerve tibial) and stretching the plantar region and sural triceps, following the recommendations described by Mcpoil et al. (2008).', 'armGroupLabels': ['Manual Therapy']}, {'name': 'Manual Therapy and Hip Strengthening', 'type': 'OTHER', 'description': 'It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip (iliac muscle, psoas, gluteus maximus, gluteus medius and gluteus minimus) and the treatment schedule established for this intervention is the use of exercises with progressive resistance. Will be performed 3 sets of 10 reps with 30 seconds rest between each set, according to the guidelines of the American College of Sports Medicine (ACSM, 2014). The home exercises consist of repeating the same procedures performed for supervised strengthening. The calculation of the ideal individual load will be carried by Brzycki formula, i.e. one repetition maximum (1RM) = weight ÷ \\[1.0278 - (0.0278 x number of repetitions)\\] as was used by (Shirazi et al., 2007).', 'armGroupLabels': ['Manual Therapy and Hip Strengthening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitário Gaffréé Guinle', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Leandro AC Nogueira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Universitário Augusto Motta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitário Augusto Motta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}