Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594796
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
A Combined Lifestyle Intervention Delivered by Physioexercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Combined Lifestyle Intervention Delivered by Physioexercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity a Randomized Controlled Trial with Parallel Economic Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Back2Health
Brief Summary:
Low back pain LBP is the leading cause of disability worldwide and is costly Lifestyle factors such as physical inactivity stress sleep excess weight and an unhealthy diet contribute to the burden of LBP and the associated increasing demand for care Moreover approximately 65 of LBP patients who visit the hospital are overweight This group is considered a complex patient group Of the LBP patients who visit the hospital 74 are referred back to primary care as medical specialists cannot offer them high value care Targeting both lifestyle factors eg physical activity sleep and stress and clinical factors related to low back pain eg muscle strength endurance mobility is important in the management of this group of LBP patients to improve important outcomes eg functioning physical activity and reduce costs Addressing lifestyle factors may also offer additional health benefits like decreased risks of diabetes and cardiovascular diseases
The primary objective of this project is to improve the management of this complex group of LBP patients that is patients who are overweight or obese and who are referred back to primary care from the hospital because medical specialists cannot offer them high value care and to reduce healthcare and societal costs The primary research question is Is a combined lifestyle intervention integrated into standard care for LBP delivered by physioexercise therapists effective and cost-effective in improving physical functioning andor physical activity over a 36-month period compared to usual care in overweight or obese LBP patients who are referred back from the hospital to primary care It is hypothesized that the combined lifestyle intervention integrated into standard care for LBP is both effective and cost-effective in managing LBP in patients who are overweight or obese over a 36-month period
The primary objective of this project is to improve the management of this complex group of LBP patients that is patients who are overweight or obese and who are referred back to primary care from the hospital because medical specialists cannot offer them high value care and to reduce healthcare and societal costs The primary research question is Is a combined lifestyle intervention integrated into standard care for LBP delivered by physioexercise therapists effective and cost-effective in improving physical functioning andor physical activity over a 36-month period compared to usual care in overweight or obese LBP patients who are referred back from the hospital to primary care It is hypothesized that the combined lifestyle intervention integrated into standard care for LBP is both effective and cost-effective in managing LBP in patients who are overweight or obese over a 36-month period
Detailed Description:
None
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