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| Name | Class |
|---|---|
| Aleris | UNKNOWN |
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The purpose of this project is to investigate the efficacy of the hip belt squat exercise in pain management and physical function for people with chronic low back pain.
This study is a randomized controlled trial (RCT) designed to evaluate the effectiveness of a 12-week hip belt squat (HBS) intervention for patients with non-specific low back pain (LBP). Participants, aged 18-60 with LBP for more than 12 weeks, are randomly assigned to either the intervention group or a control group. The control group will not receive any intervention, whereas the HBS intervention consists of two supervised sessions per week for 12 weeks, with load adjustments based on perceived exertion.
The study aims to recruit 50-60 patients to ensure sufficient statistical power. Primary outcomes include health-related quality of life (EQ-5D-5L), fear-avoidance beliefs (FABQ), functional ability (ODI), risk of chronicity (STarTBack), pain intensity (VAS), and pain sensitivity (PPT). Secondary outcomes include body composition (DEXA), lumbar flexibility, maximal muscle strength (5RM), physical activity (GPAQ), tobacco use (SQ), and work-related stress (WSQ).
Measurements are taken at baseline, 6 weeks, 12 weeks, and a 1-year follow-up for various outcomes. This comprehensive approach aims to provide valuable insights into the effectiveness of the HBS intervention for managing LBP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Low back pain patients not performing an intervention | |
| Hip belt squat exercise | Experimental | Low back pain patients performing hip belt squat training twice per week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip belt squat exercise | Other | Hip belt squat exercise performed twice per week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswetry Disability index | A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden). | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Health related quality of life | A questionnaire measuring the easured health-related quality of life (EuroQOL-5D), ranging from -0.596 to 1, with higher scores indicating better quality of life. | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Fear-avoidance Beliefs Questionnaire | Fear-avoidance Beliefs Questionnaire (FABQ) measuring the amount of kinesiophobia, ranging from 0-96 with higher scores indicating higher levels of fear avoidance belief. | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| STarTBack tool | A questionnaire used to assess the risk of chronicity in low back pain (ranging from low to medium to high risk). | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Pain sensitivity | Pressure-pain threshold was assessed using a handheld pressure algometer. | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Pain intensity | Patients were asked to rate the intensity of their LBP on a visual analog scale (VAS) using a 10 cm long line, where the far-left part of the line (0/10) corresponded to no pain and the far right part (10/10) corresponded to the worst imaginable pain. Ratings on the VAS scale was gathered both while the participants stood in an upright position and during a self-chosen movement known to induce pain (e.g. bending over). |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | Muscle strength was assessed in the hop belt squat exercise using a 5 repetition maximum test | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Lumbar flexibility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathias Kristiansen, PhD | Contact | +4526803461 | mvk@hst.aau.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Gistrup | 9260 | Denmark |
Individual participant data is protected under GDPR
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
Lumbar flexibility was assessed using a custom made test.
| Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Body composition | To assess changes in body composition a DEXA scan was performed. This test quantified lean body mass (kg) and fat mass (kg). | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Physical activity level | To assess the physical activity level of the patients the Global Physical Activity Questionnaire (GPAQ) questionnaire was used. Higher scores indicate higher levels of physical activity, which is considered better for health. Lower scores indicate lower levels of physical activity, which is considered worse for health. Interpretation: High Physical Activity: More than 3000 MET-minutes per week. Moderate Physical Activity: Between 600 and 3000 MET-minutes per week. Low Physical Activity: Less than 600 MET-minutes per week. | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Tobacco use | To assess tobacco use, patients were questioned using the Smoking Questionnaire (SQ). | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| Work related stress | To assess work related stress, the Work Stress Questionnaire (WSQ) was used. Lower scores indicate lower levels of work-related stress, which is considered better for overall well-being. Higher scores indicate higher levels of work-related stress, which can negatively impact health and job performance. Interpretation: Scores below 135: Indicate a normal level of work-related stress. Scores of 135 or above: Suggest an unusual amount of work-related stress, indicating the need for stress management interventions. | Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup |
| D013568 |
| Pathological Conditions, Signs and Symptoms |