Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain

Study Overview
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Brief Summary
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Low back pain is a common disorder, occurring worldwide in both males and females in all age groups. 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. The aim of this randomized clinical trial study is to evaluate the effects of a HIT program on disease related outcomes, physical fitness and muscle contractile characteristics compared to a conventional rehabilitation program in persons with NSCLBP.

Official Title
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Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: high intensity training (HIT) program
* Other: moderate intensity training (MIT) exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medically diagnosed with non-specific chronic low back pain, over 25 years old, Oswestry Disability Index: disability score >20%, able to understand Dutch (spoken and written), Physical Activities Scale For Individuals with Physical Disabilities <30. - Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the 'cardio' HIT group<br>Group 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group). | Other: high intensity training (HIT) program<br>* The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.<br>|
| Experimental: the 'general' HIT group<br>Group 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ). | Other: high intensity training (HIT) program<br>* The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.<br>|
| Experimental: the 'lumbar' HIT group<br>Group 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group). | Other: high intensity training (HIT) program<br>* The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.<br>|
| Experimental: the 'combined' HIT group<br>Group 4 receives HIT exercise which is a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'combined' HIT group). These trainings will take place in the REVAL Rehabilitation Research Center on the campus of Hasselt University in Diepenbeek. | Other: high intensity training (HIT) program<br>* The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.<br>|
| Active Comparator: control group<br>Group 5 receives MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group) | Other: moderate intensity training (MIT) exercise therapy<br>* MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | The Numeric Pain Rating Scale (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. | day 1 | 
| pain | The Numeric Pain Rating Scale (NPRS) | week 6 | 
| pain | The Numeric Pain Rating Scale (NPRS) | week 12 | 
| Kinesiophobia | The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear. | day 1 | 
| Kinesiophobia | The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear. | week 6 | 
| Kinesiophobia | The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear. | week 12 | 
| Physical disability RMDQ | The Roland Morris Disability Questionnaire (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 living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference. | day 1 | 
| Physical disability RMDQ | The Roland Morris Disability Questionnaire (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 living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference. | week 6 | 
| Physical disability RMDQ | The Roland Morris Disability Questionnaire (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 living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference. | week 12 | 
| Endurance capacity | Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer | day 1 | 
| Endurance capacity | Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer | week 6 | 
| Endurance capacity | Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer | week 12 | 
| Abdominal/back strength | The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York). | day 1 | 
| Abdominal/back strength | The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York). | week 6 | 
| Abdominal/back strength | The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York). | week 12 | 
| Muscle Biopsy | muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.). Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise. | day 1 | 
| Muscle Biopsy | muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.). Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise. | week 12 | 
| Physical disability ODI | The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient. | day 1 | 
| Physical disability ODI | The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient. | week 6 | 
| Physical disability ODI | The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient. | week 12 | 
| activity level | Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days. | day 1 | 
| activity level | Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days. | week 6 | 
| activity level | Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan. | day 1 | 
| Body composition | The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan. | week 6 | 
| Body composition | The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan. | week 12 | 
| physical activity tracking | Activity of the daily routine will be evaluated by means of wearing an accelerometer (Actigraph GT3X activity monitors) (2 midweek days and 1 weekend day, 3 consecutive days) throughout the day. A schedule will be inventoried by the participant (diary). | day 1 | 
| physical activity tracking | Activity of the daily routine will be evaluated by means of wearing an accelerometer (Actigraph GT3X activity monitors) (2 midweek days and 1 weekend day, 3 consecutive days) throughout the day. A schedule will be inventoried by the participant (diary). | week 12 | 
| disability in participation and quality of life | Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each. | day 1 | 
| disability in participation and quality of life | Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each. | week 6 | 
| disability in participation and quality of life | Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each. | week 12 | 
| Motivation VAS | The start motivation is measured by a visual analog scale (VAS). | day 1 | 
| Motivation IMI | At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1). | day 1 | 
| Motivation VAS | The start motivation is measured by a visual analog scale (VAS). | week 6 | 
| Motivation IMI | At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1). | week 6 | 
| Motivation VAS | The start motivation is measured by a visual analog scale (VAS). | week 12 | 
| Motivation IMI | At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1). | week 12 |