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Completed

NCT Number: NCT06594731

Belt Squat Training for Non-Specific Low Back Pain

The purpose of this project is to investigate the feasibility of using belt squat as an exercise intervention for people with chronic low back pain. We will recruit people with chronic low back pain as well as asymptomatic controls

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Gistrup, 9260, Denmark

About this study

The purpose of the current project is to evaluate the feasibility of performing belt squats in healthy participants and persistent non-specific low back pain (LBP) patients.

For this project we wish to recruit 20 healthy volunteers 20 volunteers LBP patients through notices at Aalborg University, on www.forsog.dk, and on Facebook. The following inclusion and exclusion criteria will be used for the healthy subjects:

Healthy men and women, age 18-60.

And for the LBP patients:

Non-specific LBP for more than twelve weeks without major sciatica (back pain >leg pain), age 18-60.

Exclusion criteria

pertinent to all subjects were:

Leg pain greater than back pain, neuromuscular disorders, spinal or lower extremity fractures, infections, cancer, osteoporosis, dementia, BMI>35, current substance abuse, former lumbar surgery, persistent pain syndromes other than back pain, inflammatory rheumatic diseases.

In the study, participants will perform hip belt squat training twice per week for 6 weeks.

To test the feasibility of performing hip belt squat training in healthy participants and persistent LBP patients the project will be based on the Bowen feasibility model. This model lists eight different focus areas for feasibility studies, where this particular sub-project will focus on four of these areas being: acceptability, demand, implementation, and practicality.

To test the acceptability and demand, subjects will be interviewed on their satisfaction, intention to continue use, actual use, perceived appropriateness, and perceived demand of the training.

Implementation and practicality will be assessed by evaluation of the degree of execution, success or failure of execution, factors affecting implementation ease or difficulty, positive/negative effects on participants, ability of participants to carry out the training activities and a cost analysis.

Lastly, to test the acceptance of methods relevant to the training, measures on lumbar flexibility, muscle strength, muscle mass (DEXA scan), pain sensitivity (pressure-pain threshold, PPT) using a handheld pressure algometer (Somedic, Sweden), muscle activity (Electromyographic measurement, EMG) and the following questionnaires: Fear-avoidance Beliefs Questionnaire (FABQ), Oswestry Disability Index (ODI) (which ranges from 0 (no disability) to 100 (bedridden)), health-related quality of life as measured by EuroQOL-5D (EQ-5D) (ranging from -0.596 to 1, with higher scores indicating better quality of life) will be carried out

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women
  • Men and women with non-specific low back pain for more than twelve weeks

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 training

Other

Hip belt squat training performed twice per week for 6 weeks

Primary outcomes

  1. Acceptability

    Time frame: Immediately after the intervention

    Acceptability of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the intervention was acceptable or not.

  2. Demand

    Time frame: Immediately after the intervention

    Demand of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the participants wish to incorporate belt squats into their future training.

  3. Implementation

    Time frame: Immediately after the intervention

    Implementation of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the intervention was feasible or not.

  4. Practicality

    Time frame: Immediately after the intervention

    Practicality will be assessed by evaluation of the adherence level, computed as the percentage of completed training sessions.

Secondary outcomes

  1. Pain sensitivity

    Time frame: Assessed at baseline and immediately after the intervention period

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

  2. Muscle strength

    Time frame: Assessed at baseline and immediately after the intervention period

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

  3. Lumbar flexibility

    Time frame: Assessed at baseline and immediately after the intervention period

    Lumbar flexibility was assessed using a custom made test.

  4. Muscle activity

    Time frame: Assessed at baseline and immediately after the intervention period

    Electromyography was used to assess muscle activation.

  5. Oswetry Disability index

    Time frame: Assessed at baseline and immediately after the intervention period

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

  6. Health related quality of life

    Time frame: Assessed at baseline and immediately after the intervention period

    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.

  7. Fear-avoidance Beliefs Questionnaire

    Time frame: Assessed at baseline and immediately after the intervention period

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

  8. Body composition

    Time frame: Assessed at baseline and immediately after the intervention period

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

Sponsors and collaborators

Lead sponsor

Mathias Kristiansen

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study title

Belt Squat Training for Individuals with Chronic Non-Specific Low Back Pain - a Feasibility Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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