Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01318720
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2011-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2011-03-17', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'Short-term outcome 1 week', 'description': 'Neck Disability Index (NDI) is a disease-specific outcome measure specifically used in patients with neck pain. The NDI has been shown to be reliable and valid in individuals with mechanical neck pain.'}], 'secondaryOutcomes': [{'measure': 'Global Rating of Change (GROC)', 'timeFrame': 'Short-term outcome 1 week', 'description': 'The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neck Pain', 'Thrust Manipulation', 'Non-Thrust Manipulation'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Neck pain of less than 3 months\n* No symptoms below the shoulder\n* Baseline Neck Disability Index score of 10 or greater\n\nExclusion Criteria:\n\n* Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)\n* History of whiplash injury within the past two months\n* Diagnosis of cervical spinal stenosis\n* Uni-lateral or bi-lateral upper extremity radicular symptoms\n* Evidence of central nervous system involvement\n* Two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes\n* Prior surgery to the neck or thoracic spine\n* Pending legal action regarding their neck pain, or patients with no fault or workers compensation claims\n* Insufficient English language skills to complete the questionnaires\n* Inability to comply with treatment and follow-up schedule\n* Women who may be pregnant"}, 'identificationModule': {'nctId': 'NCT01318720', 'briefTitle': 'Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine', 'organization': {'class': 'OTHER', 'fullName': 'Masefield and Cavallaro Physical Therapy'}, 'officialTitle': 'Short-Term Combined Effects of Thoracic Spine Thrust Manipulation and Cervical Spine Non-Thrust Manipulation in Patients With Mechanical Neck Pain: A RCT', 'orgStudyIdInfo': {'id': 'MCPT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manipulation', 'description': 'The experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation.', 'interventionNames': ['Other: Manual Therapy']}], 'interventions': [{'name': 'Manual Therapy', 'type': 'OTHER', 'description': 'Thrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s)', 'armGroupLabels': ['Manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island University', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11228', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Masefield Cavallaro Physical Therapy', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masefield Cavallaro Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masefield and Cavallaro Physical Therapy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Staff Physical Therapist', 'investigatorFullName': 'Michael Masaracchio PT, DPT, PhD(c), OCS, SCS', 'investigatorAffiliation': 'Masefield and Cavallaro Physical Therapy'}}}}