Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 10:33 AM
Study NCT ID:
NCT00128869
Status:
COMPLETED
Last Update Posted:
2008-05-13
First Post:
2005-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-08', 'studyFirstSubmitDate': '2005-08-09', 'studyFirstSubmitQcDate': '2005-08-09', 'lastUpdatePostDateStruct': {'date': '2008-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Diagram and Scale'}, {'measure': 'Neck Disability Scale'}, {'measure': 'Global Rating of Change Scale'}], 'secondaryOutcomes': [{'measure': 'Side Effects Questionnaire'}]}, 'conditionsModule': {'keywords': ['Manipulation', 'Mobilization', 'Neck Pain', 'Physical Therapy'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '9122645', 'type': 'BACKGROUND', 'citation': 'Norlander S, Aste-Norlander U, Nordgren B, Sahlstedt B. Mobility in the cervico-thoracic motion segment: an indicative factor of musculo-skeletal neck-shoulder pain. Scand J Rehabil Med. 1996 Dec;28(4):183-92.'}, {'pmid': '9271151', 'type': 'BACKGROUND', 'citation': 'Norlander S, Gustavsson BA, Lindell J, Nordgren B. Reduced mobility in the cervico-thoracic motion segment--a risk factor for musculoskeletal neck-shoulder pain: a two-year prospective follow-up study. Scand J Rehabil Med. 1997 Sep;29(3):167-74.'}, {'pmid': '9825389', 'type': 'BACKGROUND', 'citation': 'Norlander S, Nordgren B. Clinical symptoms related to musculoskeletal neck-shoulder pain and mobility in the cervico-thoracic spine. Scand J Rehabil Med. 1998 Dec;30(4):243-51. doi: 10.1080/003655098443995.'}, {'type': 'RESULT', 'citation': 'Flynn TW, Wainner RS, Whitman JM. Immediate effects of thoracic spine manipulation on cervical range of motion and pain. Journal or Manual and Manipulative Therapy. 9(3), 164-171. 2001'}, {'pmid': '15922233', 'type': 'RESULT', 'citation': 'Cleland JA, Childs JD, McRae M, Palmer JA, Stowell T. Immediate effects of thoracic manipulation in patients with neck pain: a randomized clinical trial. Man Ther. 2005 May;10(2):127-35. doi: 10.1016/j.math.2004.08.005.'}], 'seeAlsoLinks': [{'url': 'http://www.APTA.org', 'label': 'American Physical Therapy Association Web Site'}, {'url': 'http://aaompt.org', 'label': 'American Academy of Orthopaedic Manual Physical Therapy web site'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare whether or not there is a difference in the effectiveness of upper back (thoracic spine) mobilizations versus manipulations used in a population of patients with mechanical neck pain. The investigators hypothesize that patients receiving a manipulative technique will experience better outcomes than patients receiving the mobilization techniques and these results will be evident at a 48-hour follow-up.', 'detailedDescription': "Patients with mechanical neck pain who meet the study's inclusion criteria, who do not meet the study's exclusion criteria will be offered an opportunity to participate in this study. They will be issued an informed consent detailing the study and will have time to decide whether or not to participate. Once they have enlisted in the study they will complete forms to assess their current functional level. The investigator will then perform a standard clinical exam on the upper quarter to include a comprehensive subjective examination, upper extremity strength, reflexes, sensory assessment, cervical range of motion, thoracic range of motion and pain assessment. Once the above data have been collected and the patient has met the criteria for the study, a second investigator will then choose a randomized and sealed envelope which will indicate the treatment to be performed. The patient will either receive mobilization or manipulation to the thoracic spine. Mobilizations will be performed in prone over the spinous processes of T1-T6. Each one will be performed for 30 seconds each with force directed posterioanterior. The manipulation will be performed in supine with the patient's arms crossed over his/her chest. The therapist will pull the patient's arms downward to create spinal flexion down to the level where the manipulation will occur. The therapist's manipulative hand will stabilize the lower vertebrae of the motion segment and his/her body will be used to push down through the patient's arms to perform a high velocity, low amplitude thrust of the superior vertebrae. The manipulation will first be attempted in the upper thoracic spine; if a cavitation is heard on the first attempt he/she will move onto the middle thoracic area. If a cavitation is not heard he/she will attempt a second time before moving on to the next area. Both areas will receive a maximum of two attempts. Once the manipulation or mobilization is performed the patient will be assigned one home exercise which includes rotation of the cervical spine in both directions for 10 reps, 3-4 times per day. The patient will return within 48 hours for final data collection which will include a global rating of change scale completed both by the therapist and the patient, pain diagram and scale, neck disability index, cervical and thoracic range of motion measurements, and a side effects questionnaire. The patient will then be discharged from the study and will continue with physical therapy as deemed appropriate at the time of examination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary complaint of neck pain with duration of symptoms greater than 4 weeks\n* Age between 18-60 years old\n\nExclusion Criteria:\n\n* Red flags from the medical neck screening questionnaire to include tumor, fracture, metabolic disease, rheumatoid arthritis (RA), osteoporosis, prolonged history of steroid use.\n* History of whiplash injury\n* Diagnosis of cervical spinal stenosis\n* Bilateral upper extremity symptoms\n* Evidence of central nervous system involvement to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes\n* Two or more positive neurological signs consistent with nerve root compression to include muscle weakness involving a major muscle group of the upper extremity; diminished upper extremity muscle stretch reflex; diminished or absent sensation to pinprick in any upper extremity dermatome.\n* Prior surgery to the neck or thoracic spine\n* Pending legal action regarding neck pain'}, 'identificationModule': {'nctId': 'NCT00128869', 'briefTitle': 'Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Newton-Wellesley Hospital'}, 'officialTitle': 'Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'NO5-368'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spine mobilizations', 'type': 'PROCEDURE'}, {'name': 'spine manipulations', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rees-Stealy Medical Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80919', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centennial Physical Therapy-Colorado Sport and Spine Centers', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Newton-Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '55430', 'city': 'Brooklyn Center', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Groves Physical Therapy', 'geoPoint': {'lat': 45.07608, 'lon': -93.33273}}], 'overallOfficials': [{'name': 'Paul E Glynn, DPT, OCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newton-Wellesley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newton-Wellesley Hospital', 'class': 'OTHER'}}}}