Clinical trial NCT02911987: Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain
Official title: Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2016-09-23
Enrollment: 125
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. medically diagnosed with non-specific chronic low back pain,
2. over 25 years old,
3. Oswestry Disability Index: disability score \>20%,
4. able to understand Dutch (spoken and written),
5. Physical Activities Scale For Individuals with Physical Disabilities \<30. -

Exclusion Criteria:

1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
2. radiculopathy (uni- or bilateral),
3. 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,
4. ongoing compensation claims and/or (work)disability \> 6 months,
5. rehabilitation/exercise therapy program for LBP in the past 6 months. -

Primary outcomes:
measure: pain
timeFrame: day 1
measure: pain
timeFrame: week 6
measure: pain
timeFrame: week 12
measure: Kinesiophobia
timeFrame: day 1
measure: Kinesiophobia
timeFrame: week 6
measure: Kinesiophobia
timeFrame: week 12
measure: Physical disability RMDQ
timeFrame: day 1
measure: Physical disability RMDQ
timeFrame: week 6
measure: Physical disability RMDQ
timeFrame: week 12
measure: Endurance capacity
timeFrame: day 1
measure: Endurance capacity
timeFrame: week 6
measure: Endurance capacity
timeFrame: week 12
measure: Abdominal/back strength
timeFrame: day 1
measure: Abdominal/back strength
timeFrame: week 6
measure: Abdominal/back strength
timeFrame: week 12
measure: Muscle Biopsy
timeFrame: day 1
measure: Muscle Biopsy
timeFrame: week 12
measure: Physical disability ODI
timeFrame: day 1
measure: Physical disability ODI
timeFrame: week 6
measure: Physical disability ODI
timeFrame: week 12
measure: activity level
timeFrame: day 1
measure: activity level
timeFrame: week 6
measure: activity level
timeFrame: week 12
Secondary outcomes:
measure: Body composition
timeFrame: day 1
measure: Body composition
timeFrame: week 6
measure: Body composition
timeFrame: week 12
measure: physical activity tracking
timeFrame: day 1
measure: physical activity tracking
timeFrame: week 12
measure: disability in participation and quality of life
timeFrame: day 1
measure: disability in participation and quality of life
timeFrame: week 6
measure: disability in participation and quality of life
timeFrame: week 12
measure: Motivation VAS
timeFrame: day 1
measure: Motivation IMI
timeFrame: day 1
measure: Motivation VAS
timeFrame: week 6
measure: Motivation IMI
timeFrame: week 6
measure: Motivation VAS
timeFrame: week 12
measure: Motivation IMI
timeFrame: week 12
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Annick Timmermans, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Frank Vandenabeele, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: