Low Back PainLBP-HITNCT02786316
High Intensity Training With Non-specific Chronic Low Back Pain
A study testing HIT program and conventional rehabilitation program in people with Low Back Pain, run by Hasselt University at 1 site in Belgium.
Trial summary
Low back pain is a common disorder, occurring worldwide in both males and females in all age groups1. The prevalence is higher in females and the incidence peaks between 30 and 65 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- HIT program and conventional rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically diagnosed with non-specific chronic low back pain4,
- over 18 years old,
- able to understand Dutch (spoken and written).
Who cannot join
- invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
- radiculopathy (uni- or bilateral),
- co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of > 8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,
- ongoing compensation claims and/or (work)disability > 6 months,
- rehabilitation/exercise therapy program for LBP in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Training in Patients With Non-Specific Chronic Low Back Pain: A Clinical Pilot Trial
Low back pain is a common disorder, occurring worldwide in both males and females in all age groups1. The prevalence is higher in females and the incidence peaks between 30 and 65 years. It is currently the most frequent musculoskeletal cause of functional disability and it has a major socio-economic impact on today's society. Although a small percentage of persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with low back pain present with symptoms of nonspecific origin. A part of these symptoms are only of short duration, but 23% of all people will develop nonspecific chronic low back pain (NSCLBP).
Exercise therapy (ET) is currently an important component in the treatment of NSCLBP. Previous studies analysed the effects of various modes of exercise therapy, such as motor control therapy, core stability training and aerobic conditioning training. However, therapy outcomes can be low, and guidelines in favour of using a specific program are contradictory. It thus still remains unclear which therapy modality is best suited. Furthermore, no recommendations are available about optimal training intensities during rehabilitation of persons with NSCLBP.
Read more
Since as well aerobic as muscular deconditioning are apparent in persons with chronic low back pain and improvements in overall physical fitness can affect therapy outcomes in this population, ET specifically focussing on physical fitness can be advocated for NSCLBP rehabilitation. High Intensity Training (HIT), has been promoted as an effective and efficient training method for improving physical fitness and health related parameters in healthy persons. Also, HIT resulted in successful reconditioning and improvement of functional and disease related outcomes in persons with other chronic diseases such as multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies showed promising results for the effect of HIT on low back pain such as high intensity isolated, evidence is still scarce and study results are unclear because of methodological shortcomings.To evaluate HIT for the rehabilitation of persons with NSCLBP, a therapy program was developed consisting of high intensity interval cardio and high load whole body strength training.
The aim of this pilot study is 1) to evaluate the feasibility of a HIT program for the rehabilitation of persons with NSCLBP, and 2) to evaluate the effects of a HIT program on disease related outcomes and physical fitness compared to a conventional rehabilitation program in persons with NSCLBP.
- Conditions
- Low Back Pain
- Being tested
- HIT program, conventional rehabilitation program
- 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.
HIT programOther
HIT program for the rehabilitation of persons with NSCLBP
conventional rehabilitation programOther
a conventional rehabilitation program in persons with NSCLBP
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Hit program for the rehabilitation of persons with nonspecific chronic low backpain Receives: Other: HIT program |
| Control group | Active comparator | a conventional rehabilitation program for persons with nonspecific chronic low backpain Receives: Other: conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Numeric Pain Rating Scale (NPRS) The NPRS is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant
Measured: day 1
Pain
Numeric Pain Rating Scale (NPRS) The NPRS is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant
Measured: week 6
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK) The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia41,42. A higher score relates to more pain-related fear.
Measured: day 1
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK) The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia41,42. A higher score relates to more pain-related fear.
Measured: week 6
physical disability
Roland Morris Disability Questionnaire (RMDQ) The RMDQ is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living33,35. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference36
Measured: day 1
physical disability
Roland Morris Disability Questionnaire (RMDQ) The RMDQ is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living33,35. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference36
Measured: week 6
Endurance capacity
Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
Measured: day 1
Endurance capacity
Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
Measured: week 6
Body composition
Measured by Dual Energy X-ray absorptiometry (DEXA)
Measured: day 1
Body composition
Measured by Dual Energy X-ray absorptiometry (DEXA)
Measured: week 6
weight
Measured: day 1
Weight
Measured: week 6
BMI (Body Mass Index)
Measured: day 1
BMI (Body Mass Index)
Measured: week 6
Secondary outcomes (6)
physical activity
Actigraph GT3X activity monitors Activity of the daily routine will be evaluated by means of wearing an accelerometer throughout 3 consecutive days. A schedule will be inventoried by the participant.
Measured: day 1
physical activity
Actigraph GT3X activity monitors Activity of the daily routine will be evaluated by means of wearing an accelerometer throughout 3 consecutive days. A schedule will be inventoried by the participant.
Measured: week 6
disability in participation and quality of life
Short Form Health Survey (SF-36)
Measured: day 1
disability in participation and quality of life
Short Form Health Survey (SF-36)
Measured: week 6
Questionaire motivation and Therapy Adherence
Measured: day 1
Questionaire motivation and Therapy Adherence
questionaire
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionAug 2016
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Jonas Verbrugghe, prof. dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786316
- Sponsor's protocol ID
- LBP-HIT-001
- Acronym
- LBP-HIT
- Status last verified
- Sep 2016
- First submitted
- 19 May 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Training in Patients With Non-Specific Chronic Low Back Pain: A Clinical Pilot Trial
- ClinicalTrials.gov ID
- NCT02786316
- Acronym / sponsor ID
- LBP-HIT / LBP-HIT-001
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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.
Low back pain is a common disorder, occurring worldwide in both males and females in all age groups1. The prevalence is higher in females and the incidence peaks between 30 and 65 years. It is currently the most frequent musculoskeletal cause of functional disability and it has a major socio-economic impact on today's society. Although a small percentage of persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with low back pain present with symptoms of nonspecific origin. A part of these symptoms are only of short duration, but 23% of all people will develop nonspecific chronic low back pain (NSCLBP).
Exercise therapy (ET) is currently an important component in the treatment of NSCLBP. Previous studies analysed the effects of various modes of exercise therapy, such as motor control therapy, core stability training and aerobic conditioning training. However, therapy outcomes can be low, and guidelines in favour of using a specific program are contradictory. It thus still remains unclear which therapy modality is best suited. Furthermore, no recommendations are available about optimal training intensities during rehabilitation of persons with NSCLBP.
Since as well aerobic as muscular deconditioning are apparent in persons with chronic low back pain and improvements in overall physical fitness can affect therapy outcomes in this population, ET specifically focussing on physical fitness can be advocated for NSCLBP rehabilitation. High Intensity Training (HIT), has been promoted as an effective and efficient training method for improving physical fitness and health related parameters in healthy persons. Also, HIT resulted in successful reconditioning and improvement of functional and disease related outcomes in persons with other chronic diseases such as multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies showed promising results for the effect of HIT on low back pain such as high intensity isolated, evidence is still scarce and study results are unclear because of methodological shortcomings.To evaluate HIT for the rehabilitation of persons with NSCLBP, a therapy program was developed consisting of high intensity interval cardio and high load whole body strength training.
The aim of this pilot study is 1) to evaluate the feasibility of a HIT program for the rehabilitation of persons with NSCLBP, and 2) to evaluate the effects of a HIT program on disease related outcomes and physical fitness compared to a conventional rehabilitation program in persons with NSCLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: HIT programHit program for the rehabilitation of persons with nonspecific chronic low backpain |
| Control group | Active comparator | Other: conventional rehabilitation programa conventional rehabilitation program for persons with nonspecific chronic low backpain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medically diagnosed with non-specific chronic low back pain4,
- over 18 years old,
- able to understand Dutch (spoken and written).
Key exclusion criteria (5 listed)
- invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
- radiculopathy (uni- or bilateral),
- co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of > 8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,
- ongoing compensation claims and/or (work)disability > 6 months,
- rehabilitation/exercise therapy program for LBP in the past 6 months.
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 |
|---|---|---|
| HIT programHIT program for the rehabilitation of persons with NSCLBP | Other | intervention group |
| conventional rehabilitation programa conventional rehabilitation program in persons with NSCLBP | Other | Control group |
Primary outcome
Pain
Time frame: day 1
Numeric Pain Rating Scale (NPRS) The NPRS is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant
Pain
Time frame: week 6
Numeric Pain Rating Scale (NPRS) The NPRS is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant
Kinesiophobia
Time frame: day 1
Tampa Scale for Kinesiophobia (TSK) The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia41,42. A higher score relates to more pain-related fear.
Kinesiophobia
Time frame: week 6
Tampa Scale for Kinesiophobia (TSK) The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia41,42. A higher score relates to more pain-related fear.
physical disability
Time frame: day 1
Roland Morris Disability Questionnaire (RMDQ) The RMDQ is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living33,35. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference36
physical disability
Time frame: week 6
Roland Morris Disability Questionnaire (RMDQ) The RMDQ is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living33,35. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference36
Endurance capacity
Time frame: day 1
Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
Endurance capacity
Time frame: week 6
Endurance capacity test Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer (eBike Basic, General Electric GmbH, Bitz, Germany).
Body composition
Time frame: day 1
Measured by Dual Energy X-ray absorptiometry (DEXA)
Body composition
Time frame: week 6
Measured by Dual Energy X-ray absorptiometry (DEXA)
weight
Time frame: day 1
Weight
Time frame: week 6
BMI (Body Mass Index)
Time frame: day 1
BMI (Body Mass Index)
Time frame: week 6
6 secondary outcomes
physical activity
Time frame: day 1
physical activity
Time frame: week 6
disability in participation and quality of life
Time frame: day 1
disability in participation and quality of life
Time frame: week 6
Questionaire motivation and Therapy Adherence
Time frame: day 1
Questionaire motivation and Therapy Adherence
Time frame: week 6
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 2016.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
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Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
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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.
Jonas Verbrugghe, prof. dr. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIT program and conventional rehabilitation program in people with Low Back Pain, run by Hasselt University at 1 site in Belgium.
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 3 inclusion and 5 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 2016. 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 Belgium. 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?
Pain (time frame: day 1). The study lists 14 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 2016.