Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT00916734
Status:
COMPLETED
Last Update Posted:
2011-12-05
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation
Sponsor:
Daemen College
Organization:
Study Overview
Official Title:
Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation
Status:
COMPLETED
Status Verified Date:
2011-12
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:
The purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). The investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.
Detailed Description:
With the trends in health care focusing on treatment effectiveness, it is important for physical therapists to select the most appropriate intervention according to patient classification. Physical therapy interventions for management of LBP include therapeutic exercises and spinal manipulation.
The purpose of this study is to determine whether patients who fit the Clinical Prediction Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference.
The subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in MDT who had experience treating patients through the use of spinal manipulation. Patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome.
Following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. Patients will be included in the study if they meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance with their assigned group. The assessment tools administered at the initial examination will be readministered for follow-up analysis.
The purpose of this study is to determine whether patients who fit the Clinical Prediction Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference.
The subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in MDT who had experience treating patients through the use of spinal manipulation. Patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome.
Following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. Patients will be included in the study if they meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance with their assigned group. The assessment tools administered at the initial examination will be readministered for follow-up analysis.
Study Oversight
Has Oversight DMC:
True
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?: