Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128869
Status:
COMPLETED
Last Update Posted:
2008-05-13
First Post:
2005-08-09
Brief Title:
Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain
Sponsor:
Newton-Wellesley Hospital
Organization:
Newton-Wellesley Hospital
Study Overview
Official Title:
Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Patients with mechanical neck pain who meet the studys inclusion criteria who do not meet the studys 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 patients arms crossed over hisher chest The therapist will pull the patients arms downward to create spinal flexion down to the level where the manipulation will occur The therapists manipulative hand will stabilize the lower vertebrae of the motion segment and hisher body will be used to push down through the patients 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 heshe will move onto the middle thoracic area If a cavitation is not heard heshe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None