Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594731
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Belt Squat Training for Non-Specific Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Belt Squat Training for Individuals with Chronic Non-Specific Low Back Pain - a Feasibility Study
Status:
COMPLETED
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:
None
Brief Summary:
The purpose of this project is to investigate the feasibility of using belt squat as an exercise intervention for people with chronic low back pain We will recruit people with chronic low back pain as well as asymptomatic controls
Detailed Description:
The purpose of the current project is to evaluate the feasibility of performing belt squats in healthy participants and persistent non-specific low back pain LBP patients
For this project we wish to recruit 20 healthy volunteers 20 volunteers LBP patients through notices at Aalborg University on wwwforsogdk and on Facebook The following inclusion and exclusion criteria will be used for the healthy subjects
Healthy men and women age 18-60
And for the LBP patients
Non-specific LBP for more than twelve weeks without major sciatica back pain gtleg pain age 18-60
Exclusion criteria pertinent to all subjects were
Leg pain greater than back pain neuromuscular disorders spinal or lower extremity fractures infections cancer osteoporosis dementia BMIgt35 current substance abuse former lumbar surgery persistent pain syndromes other than back pain inflammatory rheumatic diseases
In the study participants will perform hip belt squat training twice per week for 6 weeks
To test the feasibility of performing hip belt squat training in healthy participants and persistent LBP patients the project will be based on the Bowen feasibility model This model lists eight different focus areas for feasibility studies where this particular sub-project will focus on four of these areas being acceptability demand implementation and practicality
To test the acceptability and demand subjects will be interviewed on their satisfaction intention to continue use actual use perceived appropriateness and perceived demand of the training
Implementation and practicality will be assessed by evaluation of the degree of execution success or failure of execution factors affecting implementation ease or difficulty positivenegative effects on participants ability of participants to carry out the training activities and a cost analysis
Lastly to test the acceptance of methods relevant to the training measures on lumbar flexibility muscle strength muscle mass DEXA scan pain sensitivity pressure-pain threshold PPT using a handheld pressure algometer Somedic Sweden muscle activity Electromyographic measurement EMG and the following questionnaires Fear-avoidance Beliefs Questionnaire FABQ Oswestry Disability Index ODI which ranges from 0 no disability to 100 bedridden health-related quality of life as measured by EuroQOL-5D EQ-5D ranging from -0596 to 1 with higher scores indicating better quality of life will be carried out
For this project we wish to recruit 20 healthy volunteers 20 volunteers LBP patients through notices at Aalborg University on wwwforsogdk and on Facebook The following inclusion and exclusion criteria will be used for the healthy subjects
Healthy men and women age 18-60
And for the LBP patients
Non-specific LBP for more than twelve weeks without major sciatica back pain gtleg pain age 18-60
Exclusion criteria pertinent to all subjects were
Leg pain greater than back pain neuromuscular disorders spinal or lower extremity fractures infections cancer osteoporosis dementia BMIgt35 current substance abuse former lumbar surgery persistent pain syndromes other than back pain inflammatory rheumatic diseases
In the study participants will perform hip belt squat training twice per week for 6 weeks
To test the feasibility of performing hip belt squat training in healthy participants and persistent LBP patients the project will be based on the Bowen feasibility model This model lists eight different focus areas for feasibility studies where this particular sub-project will focus on four of these areas being acceptability demand implementation and practicality
To test the acceptability and demand subjects will be interviewed on their satisfaction intention to continue use actual use perceived appropriateness and perceived demand of the training
Implementation and practicality will be assessed by evaluation of the degree of execution success or failure of execution factors affecting implementation ease or difficulty positivenegative effects on participants ability of participants to carry out the training activities and a cost analysis
Lastly to test the acceptance of methods relevant to the training measures on lumbar flexibility muscle strength muscle mass DEXA scan pain sensitivity pressure-pain threshold PPT using a handheld pressure algometer Somedic Sweden muscle activity Electromyographic measurement EMG and the following questionnaires Fear-avoidance Beliefs Questionnaire FABQ Oswestry Disability Index ODI which ranges from 0 no disability to 100 bedridden health-related quality of life as measured by EuroQOL-5D EQ-5D ranging from -0596 to 1 with higher scores indicating better quality of life will be carried out
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