Low Back PainNCT06594731
Belt Squat Training for Non-Specific Low Back Pain
A study testing Hip belt squat training in people with Low Back Pain, run by Mathias Kristiansen at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Hip belt squat training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Men and women with non-specific low back pain for more than twelve weeks
Who cannot join
- Leg pain greater than back pain
- Neuromuscular disorders
- Spinal or lower extremity fractures
- Infections
- Cancer
- Osteoporosis
Show all 11Show fewer
- Dementia
- Current substance abuse
- Former lumbar surgery
- Persistent pain syndromes other than back pain
- Inflammatory rheumatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Belt Squat Training for Individuals with Chronic Non-Specific Low Back Pain - a Feasibility Study
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
Read the 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 \>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
- Conditions
- Low Back Pain
- Being tested
- Hip belt squat training
- Keywords
- Feasibility study
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip belt squat trainingOther
Hip belt squat training performed twice per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low back pain patients | Experimental | Low back pain subjects performing hip belt squat training twice per week for 6 weeks. Receives: Other: Hip belt squat training |
| Healthy individuals | Active comparator | Healthy individuals performing hip belt squat training twice per week for 6 weeks. Receives: Other: Hip belt squat training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
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.
Measured: Immediately after the intervention
Demand
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.
Measured: Immediately after the intervention
Implementation
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.
Measured: Immediately after the intervention
Practicality
Practicality will be assessed by evaluation of the adherence level, computed as the percentage of completed training sessions.
Measured: Immediately after the intervention
Secondary outcomes (8)
Pain sensitivity
Pressure-pain threshold was assessed using a handheld pressure algometer.
Measured: Assessed at baseline and immediately after the intervention period
Muscle strength
Muscle strength was assessed in the hop belt squat exercise using a 5 repetition maximum test
Measured: Assessed at baseline and immediately after the intervention period
Lumbar flexibility
Lumbar flexibility was assessed using a custom made test.
Measured: Assessed at baseline and immediately after the intervention period
Muscle activity
Electromyography was used to assess muscle activation.
Measured: Assessed at baseline and immediately after the intervention period
Oswetry Disability index
A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden).
Measured: Assessed at baseline and immediately after the intervention period
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.
Measured: Assessed at baseline and immediately after the intervention period
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.
Measured: Assessed at baseline and immediately after the intervention period
Body composition
To assess changes in body composition a DEXA scan was performed. This test quantified lean body mass (kg) and fat mass (kg).
Measured: Assessed at baseline and immediately after the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2024
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathias Kristiansen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Mathias Kristiansen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594731
- Sponsor's protocol ID
- N-20230063
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belt Squat Training for Individuals with Chronic Non-Specific Low Back Pain - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06594731
- Acronym / sponsor ID
- N-20230063
- Conditions
- Low Back Pain
- Keywords
- Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mathias KristiansenUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \>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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain patients | Experimental | Other: Hip belt squat trainingLow back pain subjects performing hip belt squat training twice per week for 6 weeks. |
| Healthy individuals | Active comparator | Other: Hip belt squat trainingHealthy individuals performing hip belt squat training twice per week for 6 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Men and women with non-specific low back pain for more than twelve weeks
Key exclusion criteria (11 listed)
- Leg pain greater than back pain
- Neuromuscular disorders
- Spinal or lower extremity fractures
- Infections
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip belt squat trainingHip belt squat training performed twice per week for 6 weeks | Other | Healthy individuals, Low back pain patients |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Pain sensitivity
Time frame: Assessed at baseline and immediately after the intervention period
Muscle strength
Time frame: Assessed at baseline and immediately after the intervention period
Lumbar flexibility
Time frame: Assessed at baseline and immediately after the intervention period
Muscle activity
Time frame: Assessed at baseline and immediately after the intervention period
Oswetry Disability index
Time frame: Assessed at baseline and immediately after the intervention period
Health related quality of life
Time frame: Assessed at baseline and immediately after the intervention period
Fear-avoidance Beliefs Questionnaire
Time frame: Assessed at baseline and immediately after the intervention period
Body composition
Time frame: Assessed at baseline and immediately after the intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip belt squat training in people with Low Back Pain, run by Mathias Kristiansen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.