Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:34 PM
Study NCT ID:
NCT01825460
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2013-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy to Treat Acute Whiplash Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014911', 'term': 'Whiplash Injuries'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-22', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-04-02', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on Numerical Pain Rating Scale', 'timeFrame': 'At baseline and 2 weeks', 'description': 'The numerical pain rating scale is used to record the patient´s current level of neck pain.'}], 'secondaryOutcomes': [{'measure': 'Neck disability index', 'timeFrame': 'At baseline and 2 weeks', 'description': 'The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.'}, {'measure': 'Cervical Range of Motion', 'timeFrame': 'At baseline and 2 weeks', 'description': 'Cervical range of motion is assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90º of flexion, and buttocks positioned against the back of the chair.'}, {'measure': 'Tampa scale for kinesiophobia', 'timeFrame': 'At baseline and 2 weeks', 'description': 'The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical spine', 'Neck pain', 'Manual therapy', 'Controlled clinical trial'], 'conditions': ['Whiplash Injuries']}, 'referencesModule': {'references': [{'pmid': '23465963', 'type': 'BACKGROUND', 'citation': 'Elliott JM, Kerry R, Flynn T, Parrish TB. Content not quantity is a better measure of muscle degeneration in whiplash. Man Ther. 2013 Dec;18(6):578-82. doi: 10.1016/j.math.2013.02.002. Epub 2013 Mar 5.'}, {'pmid': '23432939', 'type': 'BACKGROUND', 'citation': 'Smith J, Bolton PS. What are the clinical criteria justifying spinal manipulative therapy for neck pain?- a systematic review of randomized controlled trials. Pain Med. 2013 Apr;14(4):460-8. doi: 10.1111/pme.12041. Epub 2013 Feb 22.'}, {'pmid': '23295018', 'type': 'BACKGROUND', 'citation': 'Humphreys BK, Peterson C. Comparison of outcomes in neck pain patients with and without dizziness undergoing chiropractic treatment: a prospective cohort study with 6 month follow-up. Chiropr Man Therap. 2013 Jan 7;21(1):3. doi: 10.1186/2045-709X-21-3.'}, {'pmid': '23115473', 'type': 'BACKGROUND', 'citation': 'Isabel de-la-Llave-Rincon A, Puentedura EJ, Fernandez-de-Las-Penas C. Clinical presentation and manual therapy for upper quadrant musculoskeletal conditions. J Man Manip Ther. 2011 Nov;19(4):201-11. doi: 10.1179/106698111X13129729551985.'}, {'pmid': '22959229', 'type': 'BACKGROUND', 'citation': 'Pedler A, Motlagh H, Sterling M. Laterality judgments are not impaired in patients with chronic whiplash associated disorders. Man Ther. 2013 Feb;18(1):72-6. doi: 10.1016/j.math.2012.07.006. Epub 2012 Sep 5.'}, {'pmid': '22947552', 'type': 'BACKGROUND', 'citation': 'Stone AM, Vicenzino B, Lim EC, Sterling M. Measures of central hyperexcitability in chronic whiplash associated disorder--a systematic review and meta-analysis. Man Ther. 2013 Apr;18(2):111-7. doi: 10.1016/j.math.2012.07.009. Epub 2012 Sep 1.'}, {'pmid': '22464187', 'type': 'BACKGROUND', 'citation': 'Goldsmith R, Wright C, Bell SF, Rushton A. Cold hyperalgesia as a prognostic factor in whiplash associated disorders: a systematic review. Man Ther. 2012 Oct;17(5):402-10. doi: 10.1016/j.math.2012.02.014. Epub 2012 Mar 29.'}, {'pmid': '21955671', 'type': 'BACKGROUND', 'citation': 'Oddsdottir GL, Kristjansson E. Two different courses of impaired cervical kinaesthesia following a whiplash injury. A one-year prospective study. Man Ther. 2012 Feb;17(1):60-5. doi: 10.1016/j.math.2011.08.009. Epub 2011 Sep 28.'}, {'pmid': '21796089', 'type': 'BACKGROUND', 'citation': 'Picelli A, Ledro G, Turrina A, Stecco C, Santilli V, Smania N. Effects of myofascial technique in patients with subacute whiplash associated disorders: a pilot study. Eur J Phys Rehabil Med. 2011 Dec;47(4):561-8. Epub 2011 Jul 28.'}, {'pmid': '21406332', 'type': 'BACKGROUND', 'citation': 'Verhagen AP, Lewis M, Schellingerhout JM, Heymans MW, Dziedzic K, de Vet HC, Koes BW. Do whiplash patients differ from other patients with non-specific neck pain regarding pain, function or prognosis? Man Ther. 2011 Oct;16(5):456-62. doi: 10.1016/j.math.2011.02.009. Epub 2011 Mar 13.'}, {'pmid': '21367648', 'type': 'BACKGROUND', 'citation': 'Stokell R, Yu A, Williams K, Treleaven J. Dynamic and functional balance tasks in subjects with persistent whiplash: a pilot trial. Man Ther. 2011 Aug;16(4):394-8. doi: 10.1016/j.math.2011.01.012. Epub 2011 Mar 1.'}, {'pmid': '21295511', 'type': 'BACKGROUND', 'citation': 'Johansson MP, Baann Liane MS, Bendix T, Kasch H, Kongsted A. Does cervical kyphosis relate to symptoms following whiplash injury? Man Ther. 2011 Aug;16(4):378-83. doi: 10.1016/j.math.2011.01.004. Epub 2011 Feb 3.'}, {'pmid': '21256074', 'type': 'BACKGROUND', 'citation': 'Yu LJ, Stokell R, Treleaven J. The effect of neck torsion on postural stability in subjects with persistent whiplash. Man Ther. 2011 Aug;16(4):339-43. doi: 10.1016/j.math.2010.12.006. Epub 2011 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the short-term effects of a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.', 'detailedDescription': 'Design: Randomized clinical trial. Objectives: to determine the short-term effects of a a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.\n\nMethods and measures: sixty patients will be randomly assigned to 1 of 2 groups: the experimental group received a manual therapy protocol and the placebo group received two manual therapy techniques. Neck pain, disability and cervical range of motion data will be collected at baseline and 24-hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To met Quebec Task Force Classification of WAD II- neck pain symptoms and musculoskeletal signs.\n* No evidence of conduction loss on clinical neurological examination.\n\nExclusion Criteria:\n\n* Concussion during the motor vehicle accident.\n* Loss of consciousness.\n* Head or upper quadrant injury during the accident.\n* Sought treatment prior to their accident for neck pain.\n* A previous history of whiplash\n* Neck pain\n* Headaches\n* Psychiatric or psychologic condition\n* Neurologic or circulatory disorders'}, 'identificationModule': {'nctId': 'NCT01825460', 'briefTitle': 'Manual Therapy to Treat Acute Whiplash Injury', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Almeria'}, 'officialTitle': 'Short-Term Effects of a Manual Therapy Protocol', 'orgStudyIdInfo': {'id': 'UAL-326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual Therapy Protocol', 'description': 'A protocol with five techniques on thoracic area applied twice a week.', 'interventionNames': ['Other: Manual Therapy Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two manual techniques', 'description': 'Two manual therapies on thoracic area applied twice a week.', 'interventionNames': ['Other: Two manual techniques']}], 'interventions': [{'name': 'Manual Therapy Protocol', 'type': 'OTHER', 'description': 'The manual therapy protocol consists in the application of the following techniques: stretching diaphragm, Inhibition for phrenic center, Neuromuscular technique, technique jones and balance technique functional.', 'armGroupLabels': ['Manual Therapy Protocol']}, {'name': 'Two manual techniques', 'type': 'OTHER', 'description': 'The two manual techniques applied to control group are: inhibition for phrenic center and neuromuscular technique.', 'armGroupLabels': ['Two manual techniques']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04120', 'city': 'Almería', 'state': 'Almeria', 'country': 'Spain', 'facility': 'Adelaida María Castro-Sánchez', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}], 'overallOfficials': [{'name': 'Adelaida M Castro-Sánchez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Almeria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Almeria', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad de Granada', 'class': 'OTHER'}, {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD (Lecturer)', 'investigatorFullName': 'Adelaida María Castro-Sánchez', 'investigatorAffiliation': 'Universidad de Almeria'}}}}