Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00735735
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Substance P in Saliva of Low Back Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of Substance P in the saliva', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'chronic', 'Substance P'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '2162020', 'type': 'BACKGROUND', 'citation': 'LeVasseur SA, Gibson SJ, Helme RD. The measurement of capsaicin-sensitive sensory nerve fiber function in elderly patients with pain. Pain. 1990 Apr;41(1):19-25. doi: 10.1016/0304-3959(90)91104-Q.'}, {'pmid': '2480554', 'type': 'BACKGROUND', 'citation': 'Morton CR, Hutchison WD. Release of sensory neuropeptides in the spinal cord: studies with calcitonin gene-related peptide and galanin. Neuroscience. 1989;31(3):807-15. doi: 10.1016/0306-4522(89)90443-0.'}, {'pmid': '1696295', 'type': 'BACKGROUND', 'citation': 'Kowalski ML, Sliwinska-Kowalska M, Kaliner MA. Neurogenic inflammation, vascular permeability, and mast cells. II. Additional evidence indicating that mast cells are not involved in neurogenic inflammation. J Immunol. 1990 Aug 15;145(4):1214-21.'}, {'pmid': '2469033', 'type': 'BACKGROUND', 'citation': 'Thomas KL, Andrews PV, Khalil Z, Helme RD. Substance P induced hydrolysis of inositol phospholipids in rat skin in an in vivo model of inflammation. Neuropeptides. 1989 Apr;13(3):191-6. doi: 10.1016/0143-4179(89)90091-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain\n* A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)\n* Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)\n\nFor healthy subjects:\n\n* Volunteers with no pain (anywhere)\n* That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.\n\nExclusion Criteria:\n\n* Subjects with pain that is additional to or different from chronic low back pain'}, 'identificationModule': {'nctId': 'NCT00735735', 'briefTitle': 'Measurement of Substance P in Saliva of Low Back Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kovacs Foundation'}, 'officialTitle': 'Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain', 'orgStudyIdInfo': {'id': 'FK 26'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The taking of a saliva sample from each subject.', 'type': 'OTHER', 'description': "After taking the sample, the saliva will be transferred via a pipette to a clean tube which will be labeled with the subject's name, the date and the hour. Once a month the tubes will be sent to the collaborating laboratory for analysis."}]}, 'contactsLocationsModule': {'locations': [{'zip': '07012', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Kovacs Foundation', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Francisco M Kovacs, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kovacs Foundation, Palma de Mallorca, 07012, Spain'}, {'name': 'Mario Gestoso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kovacs Foundation,Palma de Mallorca, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovacs Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Scientific Department, Kovacs Foundation', 'investigatorFullName': 'Francisco M. Kovacs', 'investigatorAffiliation': 'Kovacs Foundation'}}}}