Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566144
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of a Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity A Randomized Controlled Blinded Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Background Low back pain is one of the most common musculoskeletal health problem with the highest prevalence in the adult population globally it represents a relevant cause of medical social and economic burden The aim of the proposed study is to determine the effect of a standard treatment for non-specific low back CNSLBP combined with multimodal osteopathy treatment on pain intensity and functional capacity
Methods This will be a blind randomized clinical trial with 44 patients with CNSLBP randomly assigned into two groups Experimental group EG treated with therapeutic exercises and multimodal osteopathy treatment n22 and Control group CG treated with therapeutic exercises n22 Participants will receive treatment twice a week total of 16 sessions The primary outcome is pain measured by numeric rating scale NRS score 0-11 points Secondary outcomes are Patient-specific functional scale scored from 0 to 30 Oswestry Disability Questionnaire ODQ finger-to-floor distance test FFD Participants will be evaluated pre- and post-treatment and after 1 and 3 months follow-up
Results Analysis will be by intention to treat using linear mixed models Comparisons between groups before and after treatment will demonstrate whether osteopathy treatment exerts a supplementary effect on pain and functional capacity in patients with CNSLBP The data will be published after the study is completed The study will support the practice of evidence-based physical therapy for individuals with CNSLBP
Methods This will be a blind randomized clinical trial with 44 patients with CNSLBP randomly assigned into two groups Experimental group EG treated with therapeutic exercises and multimodal osteopathy treatment n22 and Control group CG treated with therapeutic exercises n22 Participants will receive treatment twice a week total of 16 sessions The primary outcome is pain measured by numeric rating scale NRS score 0-11 points Secondary outcomes are Patient-specific functional scale scored from 0 to 30 Oswestry Disability Questionnaire ODQ finger-to-floor distance test FFD Participants will be evaluated pre- and post-treatment and after 1 and 3 months follow-up
Results Analysis will be by intention to treat using linear mixed models Comparisons between groups before and after treatment will demonstrate whether osteopathy treatment exerts a supplementary effect on pain and functional capacity in patients with CNSLBP The data will be published after the study is completed The study will support the practice of evidence-based physical therapy for individuals with CNSLBP
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