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

Hasselt University

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: high intensity training (HIT) program; Other: moderate intensity training (MIT) exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02911987

LBP-HIT-RCT

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 5 patient groups

the 'cardio' HIT group

Experimental group

Description:

Group 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group).

Treatment:

Other: high intensity training (HIT) program

the 'general' HIT group

Experimental group

Description:

Group 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ).

Treatment:

Other: high intensity training (HIT) program

the 'lumbar' HIT group

Experimental group

Description:

Group 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group).

Treatment:

Other: high intensity training (HIT) program

the 'combined' HIT group

Experimental group

Description:

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.

Treatment:

Other: high intensity training (HIT) program

control group

Active Comparator group

Description:

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)

Treatment:

Other: moderate intensity training (MIT) exercise therapy