Clinical trial NCT06833346: Efficacy of Hip Belt Squat Training on Pain Management and Physcial Function in Low Back Pain Patients
Official title: BASICS: Back-pain Alleviation Via a Specific and Inexpensive Contextual Strength Training Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aleris
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women with non-specific low back pain for more than twelve weeks, with a VAS score of at least 3, taken as an average of the last week, and ODI\>20

Exclusion Criteria:

* Leg pain greater than back pain
* 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

Primary outcomes:
measure: Oswetry Disability index
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Health related quality of life
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Fear-avoidance Beliefs Questionnaire
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: STarTBack tool
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Pain sensitivity
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Pain intensity
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
Secondary outcomes:
measure: Muscle strength
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Lumbar flexibility
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Body composition
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Physical activity level
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Tobacco use
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
measure: Work related stress
timeFrame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: Aalborg University
Study officials:
References: