Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-20
Brief Title:
Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain
Sponsor:
Youngstown State University
Organization:
Youngstown State University
Study Overview
Official Title:
Comparison Between Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
Both orthopedic manual therapy OMT and dry needling DN have been shown to be effective at reducing pain and disability for individuals with low back pain LBP It is unclear if one intervention or in combination with one another is more effective The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with combined OMT DN on pain and disability for patients with LBP Both within and between group effects will be presented
Patient factors such as generalized anxiety disorder depression fear-avoidance behaviors pain catastrophizing and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP Moreover sleep deprivation and pain related fear of movement functionally can change a persons pain inhibitory pathways leading to hyeralgesia These factors have been individually analyzed regarding their effects on pain related outcomes which limits our understanding of how clustering patient factors might affect recovery A secondary aim will involve determining the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN andor manual therapy
Patient factors such as generalized anxiety disorder depression fear-avoidance behaviors pain catastrophizing and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP Moreover sleep deprivation and pain related fear of movement functionally can change a persons pain inhibitory pathways leading to hyeralgesia These factors have been individually analyzed regarding their effects on pain related outcomes which limits our understanding of how clustering patient factors might affect recovery A secondary aim will involve determining the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN andor manual therapy
Detailed Description:
Low back pain LBP is a common disorder GBD2016 placing a tremendous financial burden on the health care and occupational systems Freburg2009 The etiology and influences to chronic LBP remains unknown due to multiple interacting factors involving pain disability psychosocial and psychological factors While the search for effective therapies has been ongoing in clinical trials the optimal management strategies remain elusive due to inconsistent findings in randomized clinical trials RCT and systematic reviews Bussieres2018 Coulter 2018Kamper 2015
Orthopedic manual therapy is routinely used to assist patients with LBP manage their symptoms George 2021 Mechanisms identified in pre-clinical studies involve local segmental and systemic neurophysiological changes helping reduce painBialosky2018 Two popular forms of orthopedic manual therapy are spinal manipulationmobilization therapy and dry needling DN While these treatments share mechanisms of action DN also creates a physiological lesion resulting in mechanical disruption of connective tissue to deeper structures Clinical Practice Guidelines recommend both OMT and DN be incorporated as part of a multimodal treatment planGeorge2021 It is unknown if these treatments combined produce larger treatment effects than when they are applied individually While this treatment combination has been investigated for other musculoskeletal conditions Dunning 2021a Dunning 2021b González-Iglesias2013 Gattie 2021 it has not been studied for LBP
Patient Factors that Influence Outcomes Patient factors such as generalized anxiety disorder depression fear-avoidance behaviors pain catastrophizing and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP Alhowimel2018 A recent multimodal metanalysis involving patients with depressiveanxiety disorders with chronic pain observed disorder specific neurological changes on functional MRI exploiting neuro-behavioral mechanisms Brandl 2022 Moreover sleep deprivation and pain related fear of movement functionally can change a persons pain inhibitory pathways leading to hyeralgesia Finan 2013 Meier 2017 These factors have been individually analyzed regarding their effects on pain related outcomes which limits our understanding of how clustering patient factors might affect recovery We hypothesize that certain combinations of patient factors will correlate with those patients with chronic LBP who were less likely to experience a clinically meaningful change in pain and disability
Statement of the Problems
Problem 1 The most effective conservative management strategies for patients with LBP remains unknown Manual therapy is routinely used in clinical practice and recommended in Clinical Practice Guidelines including OMT and DN It is unknown if a pragmatically applied OMT combined with DN produces larger treatment effects than a pragmatically applied SMT alone for patients with LBP
Problem 2 Patient factors such as psychological and psychosocial factors patient recovery expectations and patient treatment preferences have all demonstrated the ability to influence clinical outcomes in patients with LBP Currently it is not understood how the presence of multiple patient variables combine to interact with patient outcomes
Purpose Statement The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with OMT and DN on pain and disability for patients with LBP Both within and between group effects will be presented Our hypothesis is that individuals treated with both OMT and DN will experience greater changes in pain and disability compared with those who receive either treatment individually We also anticipate the presence of patient factors known to influence pain will negatively correlate with patient outcomes and certain combinations of these patient factors may have a stronger influence on clinical outcomes
Statement of Research Objectives
Specific Aim 1 Determine the comparative effectiveness of pragmatically applied OMT with DN compared to OMT or DN alone for patients with LBP and disability
Specific Aim 2 Determine the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN andor OMT
Orthopedic manual therapy is routinely used to assist patients with LBP manage their symptoms George 2021 Mechanisms identified in pre-clinical studies involve local segmental and systemic neurophysiological changes helping reduce painBialosky2018 Two popular forms of orthopedic manual therapy are spinal manipulationmobilization therapy and dry needling DN While these treatments share mechanisms of action DN also creates a physiological lesion resulting in mechanical disruption of connective tissue to deeper structures Clinical Practice Guidelines recommend both OMT and DN be incorporated as part of a multimodal treatment planGeorge2021 It is unknown if these treatments combined produce larger treatment effects than when they are applied individually While this treatment combination has been investigated for other musculoskeletal conditions Dunning 2021a Dunning 2021b González-Iglesias2013 Gattie 2021 it has not been studied for LBP
Patient Factors that Influence Outcomes Patient factors such as generalized anxiety disorder depression fear-avoidance behaviors pain catastrophizing and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP Alhowimel2018 A recent multimodal metanalysis involving patients with depressiveanxiety disorders with chronic pain observed disorder specific neurological changes on functional MRI exploiting neuro-behavioral mechanisms Brandl 2022 Moreover sleep deprivation and pain related fear of movement functionally can change a persons pain inhibitory pathways leading to hyeralgesia Finan 2013 Meier 2017 These factors have been individually analyzed regarding their effects on pain related outcomes which limits our understanding of how clustering patient factors might affect recovery We hypothesize that certain combinations of patient factors will correlate with those patients with chronic LBP who were less likely to experience a clinically meaningful change in pain and disability
Statement of the Problems
Problem 1 The most effective conservative management strategies for patients with LBP remains unknown Manual therapy is routinely used in clinical practice and recommended in Clinical Practice Guidelines including OMT and DN It is unknown if a pragmatically applied OMT combined with DN produces larger treatment effects than a pragmatically applied SMT alone for patients with LBP
Problem 2 Patient factors such as psychological and psychosocial factors patient recovery expectations and patient treatment preferences have all demonstrated the ability to influence clinical outcomes in patients with LBP Currently it is not understood how the presence of multiple patient variables combine to interact with patient outcomes
Purpose Statement The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with OMT and DN on pain and disability for patients with LBP Both within and between group effects will be presented Our hypothesis is that individuals treated with both OMT and DN will experience greater changes in pain and disability compared with those who receive either treatment individually We also anticipate the presence of patient factors known to influence pain will negatively correlate with patient outcomes and certain combinations of these patient factors may have a stronger influence on clinical outcomes
Statement of Research Objectives
Specific Aim 1 Determine the comparative effectiveness of pragmatically applied OMT with DN compared to OMT or DN alone for patients with LBP and disability
Specific Aim 2 Determine the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN andor OMT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None