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

NCT ID: NCT06833346

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-08-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Low back pain patients not performing an intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hip belt squat exercise

Low back pain patients performing hip belt squat training twice per week for 12 weeks.

Group Type: EXPERIMENTAL

Hip belt squat exercise

Intervention Type: OTHER

Hip belt squat exercise performed twice per week for 12 weeks

Interventions

Hip belt squat exercise

Hip belt squat exercise performed twice per week for 12 weeks

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aleris

UNKNOWN

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Mathias Kristiansen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University

Gistrup, , Denmark

Countries

Denmark

Central Contacts

Mathias Kristiansen, PhD

Role: CONTACT

mvk@hst.aau.dk

+4526803461

Facility Contacts

Mathias Kristiansen, PhD

Role: primary

mvk@hst.aau.dk

+4526803461

Other Identifiers

N-20230063-B

Identifier Type: -

Identifier Source: org_study_id