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NCT Number: NCT06833346

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip belt squat exercise

Other

Hip belt squat exercise performed twice per week for 12 weeks

Primary outcomes

  1. Oswetry Disability index

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden).

  2. Health related quality of life

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    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.

  3. Fear-avoidance Beliefs Questionnaire

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    Fear-avoidance Beliefs Questionnaire (FABQ) measuring the amount of kinesiophobia, ranging from 0-96 with higher scores indicating higher levels of fear avoidance belief.

  4. STarTBack tool

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    A questionnaire used to assess the risk of chronicity in low back pain (ranging from low to medium to high risk).

  5. Pain sensitivity

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    Pressure-pain threshold was assessed using a handheld pressure algometer.

  6. Pain intensity

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    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).

Secondary outcomes

  1. Muscle strength

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    Muscle strength was assessed in the hop belt squat exercise using a 5 repetition maximum test

  2. Lumbar flexibility

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    Lumbar flexibility was assessed using a custom made test.

  3. Body composition

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    To assess changes in body composition a DEXA scan was performed. This test quantified lean body mass (kg) and fat mass (kg).

  4. Physical activity level

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    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.

  5. Tobacco use

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    To assess tobacco use, patients were questioned using the Smoking Questionnaire (SQ).

  6. Work related stress

    Time frame: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mathias Kristiansen, PhD

CONTACT

[email protected]

+4526803461

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aleris

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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