Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2024-03-01
2024-06-30
Brief Summary
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Detailed Description
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For this project we wish to recruit 20 healthy volunteers 20 volunteers LBP patients through notices at Aalborg University, on www.forsog.dk, 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 \>leg 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, BMI\>35, 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, positive/negative 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 -0.596 to 1, with higher scores indicating better quality of life) will be carried out
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low back pain patients
Low back pain subjects performing hip belt squat training twice per week for 6 weeks.
Hip belt squat training
Hip belt squat training performed twice per week for 6 weeks
Healthy individuals
Healthy individuals performing hip belt squat training twice per week for 6 weeks.
Hip belt squat training
Hip belt squat training performed twice per week for 6 weeks
Interventions
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Hip belt squat training
Hip belt squat training performed twice per week for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Men and women with non-specific low back pain for more than twelve weeks
Exclusion Criteria
* Neuromuscular disorders
* Spinal or lower extremity fractures
* Infections
* Cancer
* Osteoporosis
* Dementia
* Current substance abuse
* Former lumbar surgery
* Persistent pain syndromes other than back pain
* Inflammatory rheumatic diseases
18 Years
60 Years
ALL
Yes
Sponsors
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Aalborg University Hospital
OTHER
Mathias Kristiansen
OTHER
Responsible Party
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Mathias Kristiansen
Associate Professor
Locations
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Aalborg University
Gistrup, , Denmark
Countries
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Other Identifiers
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N-20230063
Identifier Type: -
Identifier Source: org_study_id
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