Efficacy of Hip Belt Squat Training on Pain Management and Physcial Function in Low Back Pain Patients

BASICS: Back-pain Alleviation Via a Specific and Inexpensive Contextual Strength Training Protocol

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Hip belt squat exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathias Kristiansen, PhD; Phone Number: +4526803461; Email: mvk@hst.aau.dk

Study Locations

• Denmark
  • Gistrup, Denmark, 9260
    • Aalborg University
    • Contact: Mathias Kristiansen, PhD; Phone Number: +4526803461; Email: mvk@hst.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Low back pain patients not performing an intervention
Experimental: Hip belt squat exercise; Low back pain patients performing hip belt squat training twice per week for 12 weeks.	Other: Hip belt squat exercise; Hip belt squat exercise performed twice per week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).	Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

Secondary Outcome Measures

Outcome Measure	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	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
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
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
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

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Aleris

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: N-20230063-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is protected under GDPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No