Efficacy of Hip Belt Squat Training on Pain Management and Physcial Function in Low Back Pain Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hip belt squat exercise.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
BASICS: Back-pain Alleviation Via a Specific and Inexpensive Contextual Strength Training Protocol
Overview
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.
Interventions
- Other Hip belt squat exercise
Hip belt squat exercise performed twice per week for 12 weeks
Primary outcome measures
- Oswetry Disability index [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Health related quality of life [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Fear-avoidance Beliefs Questionnaire [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- STarTBack tool [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Pain sensitivity [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Pain intensity [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Secondary outcome measures (6)
- Muscle strength [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Lumbar flexibility [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Body composition [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Physical activity level [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Tobacco use [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
- Work related stress [Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aalborg University — Gistrup
Identifiers
NCT: NCT06833346 · N-20230063-B