Clinical trial NCT06594731: Belt Squat Training for Non-Specific Low Back Pain
Official title: Belt Squat Training for Individuals with Chronic Non-Specific Low Back Pain - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Feasibility study
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2024-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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 \&gt;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\&gt;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

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Immediately after the intervention
measure: Demand
timeFrame: Immediately after the intervention
measure: Implementation
timeFrame: Immediately after the intervention
measure: Practicality
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Pain sensitivity
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Muscle strength
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Lumbar flexibility
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Muscle activity
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Oswetry Disability index
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Health related quality of life
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Fear-avoidance Beliefs Questionnaire
timeFrame: Assessed at baseline and immediately after the intervention period
measure: Body composition
timeFrame: Assessed at baseline and immediately after the intervention period
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: Aalborg University
Study officials:
References: