Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-05 @ 1:02 AM
Study NCT ID:
NCT02696057
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in pain severity', 'timeFrame': 'change from baseline in pain severity at 6 weeks.', 'description': 'Visual Analog Scale:It is used in assessing the severity of pain. The scale is 10 cm long, which is labeled differently on each end (0= no pain, 10= the most severe pain)'}], 'secondaryOutcomes': [{'measure': 'Changes of functional status', 'timeFrame': 'change from baseline in back functions at 6 weeks.', 'description': 'Oswestry Disability Index: Various daily living activities are assessed by 10 questions each having a score of 0 to 5; points scored between 0 to 4 are recorded as no disability. Total score summed.'}, {'measure': 'Changes in Quality of life', 'timeFrame': 'change form baseline in life quality levels at 6 weeks.', 'description': 'SF-36 Quality of Life: this scale consists 36 item which assess pain, functional-emotional status, sleep, general health, mental health, social status and energy levels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '22386046', 'type': 'RESULT', 'citation': 'Slater SL, Ford JJ, Richards MC, Taylor NF, Surkitt LD, Hahne AJ. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Man Ther. 2012 Jun;17(3):201-12. doi: 10.1016/j.math.2012.01.006. Epub 2012 Mar 3.'}, {'pmid': '22072093', 'type': 'RESULT', 'citation': 'Steiger F, Wirth B, de Bruin ED, Mannion AF. Is a positive clinical outcome after exercise therapy for chronic non-specific low back pain contingent upon a corresponding improvement in the targeted aspect(s) of performance? A systematic review. Eur Spine J. 2012 Apr;21(4):575-98. doi: 10.1007/s00586-011-2045-6. Epub 2011 Nov 10.'}, {'pmid': '15125860', 'type': 'RESULT', 'citation': 'Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.'}, {'pmid': '9112710', 'type': 'RESULT', 'citation': 'Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM. Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2860-71; discussion 2872-3. doi: 10.1097/00007632-199612150-00013.'}, {'pmid': '25426289', 'type': 'RESULT', 'citation': 'Dougherty PE, Karuza J, Savino D, Katz P. Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2014 Nov 18;22(1):41. doi: 10.1186/s12998-014-0041-8. eCollection 2014.'}, {'pmid': '25816037', 'type': 'RESULT', 'citation': 'Huang SL, Liu YX, Yuan GL, Zhang J, Yan HW. Characteristics of lumbar disc herniation with exacerbation of presentation due to spinal manipulative therapy. Medicine (Baltimore). 2015 Mar;94(12):e661. doi: 10.1097/MD.0000000000000661.'}, {'pmid': '15969885', 'type': 'RESULT', 'citation': 'Kosinski MR, Schein JR, Vallow SM, Ascher S, Harte C, Shikiar R, Frank L, Margolis MK, Vorsanger G. An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system. Curr Med Res Opin. 2005 Jun;21(6):849-62. doi: 10.1185/030079905X46377.'}]}, 'descriptionModule': {'briefSummary': 'Identification of the effects of spinal stabilization exercises and manual therapy methods on pain, function and quality of life in individuals with low back pain.', 'detailedDescription': '113 patients participating in the study were divided into two groups. The patients in the physiotherapy group were instructed to perform special spinal stabilization exercises, while the patients in the manual therapy group were instructed to perform soft tissue mobilizations, muscle-energy techniques, joint mobilizations and/or manipulation methods depending on the nature of their lower back pain problems. Both groups were offered stabilization, strengthening, stretching, balance and exercise trainings as well as recommendations as to the daily life activities in line with the requirements of each individual. The severity of the pain suffered by the individuals was evaluated through a Visual Analog Scale. Oswestry Disability Index and Short Form-36 (SF-36) Scale were made respectively with respect to the functional condition and life quality. Assessments were repeated before and after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic low back pain\n* must have pain at least 3 or more according to Visual analog scale\n\nExclusion Criteria:\n\n* Clinical diagnosis of Rheumatoid Arthritis\n* Clinical diagnosis of Alzheimer\n* Clinical diagnosis of Peripheral Neuropathy\n* Clinical diagnosis of Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT02696057', 'briefTitle': 'The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Bel-boyun ağrısı Nedeniyle başvuran Hastalarda farklı Fizyoterapi ve Manuel Terapi yöntemlerinin ağrı, Fonksiyon ve yaşam Kalitesi düzeyleri üzerin Etkisi', 'orgStudyIdInfo': {'id': 'GO13/550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual technics', 'description': 'Manual technics was consisted of soft tissue technics, muscle energy technics, joint mobilization.', 'interventionNames': ['Other: manual technics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Spinal stabilization exercises were applied all the patients in this group accompanied by physiotherapist.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'manual technics', 'type': 'OTHER', 'description': 'soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.', 'armGroupLabels': ['Manual technics']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'spinal stabilization exercise applied three sessions per week, totally six week.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University, Health Sciences Faculty', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aynur Demirel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Ozlem Ulger, Asc. Proff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Seval Tamer, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Muzeyyen Oz, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Aynur Demirel', 'investigatorAffiliation': 'Hacettepe University'}}}}