Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269321
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2005-12-21
Brief Title:
Chiropractic and Exercise for Seniors With Low Back Pain
Sponsor:
Northwestern Health Sciences University
Organization:
Northwestern Health Sciences University
Study Overview
Official Title:
Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
Status:
COMPLETED
Status Verified Date:
2013-06
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 randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain 1 chiropractic manual treatment plus home exercise 2 supervised exercise plus home exercise and 3 home exercise alone
Detailed Description:
Low back pain LBP is a significant health problem for both young and geriatric individuals Of particular concern is that conditions associated with LBP such as impaired strength and flexibility can have very serious consequences for an older individuals independence and overall health
The broad long-term objective of this research is to identify effective therapies for low back pain LBP and to discover the best methods for enhancing health and functional capacity in the elderly population This study is a multi-methods clinical trial consisting of a randomized clinical trial RCT a cost-effectiveness study alongside the RCT and a qualitative study nested in the RCT
This trial builds upon a previous study of chiropractic and exercise funded by HRSA and focuses on elderly patients with sub-acute and chronic low back pain
PRIMARY AIMS
To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term after 12 weeks and long-term after 52 weeks using low back pain as the main outcome measure
1 chiropractic manual treatment plus home exercise
2 supervised rehabilitative exercise plus home exercise
3 home exercise
SECONDARY AIMS
To estimate the short- and long-term relative effectiveness of the three interventions using
Patient-rated outcomes low back disability general health status patient satisfaction improvement and medication use measured by self-report questionnaires
Objective functional performance outcomes spinal motion trunk strength and endurance and functional ability measured by examiners masked to treatment group assignment
Cost measures direct and indirect costs of treatment measured by questionnaires phone interviews and medical records
To describe elderly LBP patients perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT
The broad long-term objective of this research is to identify effective therapies for low back pain LBP and to discover the best methods for enhancing health and functional capacity in the elderly population This study is a multi-methods clinical trial consisting of a randomized clinical trial RCT a cost-effectiveness study alongside the RCT and a qualitative study nested in the RCT
This trial builds upon a previous study of chiropractic and exercise funded by HRSA and focuses on elderly patients with sub-acute and chronic low back pain
PRIMARY AIMS
To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term after 12 weeks and long-term after 52 weeks using low back pain as the main outcome measure
1 chiropractic manual treatment plus home exercise
2 supervised rehabilitative exercise plus home exercise
3 home exercise
SECONDARY AIMS
To estimate the short- and long-term relative effectiveness of the three interventions using
Patient-rated outcomes low back disability general health status patient satisfaction improvement and medication use measured by self-report questionnaires
Objective functional performance outcomes spinal motion trunk strength and endurance and functional ability measured by examiners masked to treatment group assignment
Cost measures direct and indirect costs of treatment measured by questionnaires phone interviews and medical records
To describe elderly LBP patients perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT
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