Diagnostic Imaging, Exercise Therapy, Low Back Pain, Multifidus
Conditions
Brief summary
This study examines effects of machine-based isolated lumbar extension resistance exercise (ILEX) on paraspinal muscle morphology and function, as well as pain intensity, disability and quality of life in patients with chronic low back pain and radiculopathy related to specific spinal disorders. Current guidelines emphasize the necessity of treating chronic low back pain with integrative, holistic approaches due to its multidimensional nature. At the same time, an increasing number of studies highlight the importance of restoring lumbar muscle function and morphology through targeted training. Regarding ILEX, existing studies already support its clinical value, however, the optimal integration of ILEX with other therapeutic modalities remains unclear. Two groups will be enrolled in an ILEX protocol (16 weeks, 25 sessions), while one of the groups will additionally participate in general exercise and manual therapy. After completion of the main program, participants will be given different options to continue the exercise therapy with a reduced frequency (e.g., once per month). After six months, a follow-up assessment will be conducted with all participants to analyze long-term efficacy.
Interventions
Participants in the active comparator group will perform 25 sessions of isolated lumbar extension resistance exercise (ILEX) using a new machine-based device equipped with a pelvic restraint system to ensure targeted conditioning of the paraspinal muscles. The exercise will be supplemented by visual biofeedback displayed on a computer screen. A detailed protocol will be followed, incorporating an individualized, diagnosis-based range of motion and progressive resistance overload. The supervised 16-week program consists of two sessions per week for the first nine weeks, followed by one session per week for the remaining seven weeks.
OTHERTargeted exercise as part of an integrative therapy program
Participants in the experimental group will perform 25 sessions of isolated lumbar extension resistance exercise (ILEX) using a new machine-based device equipped with a pelvic restraint system to ensure targeted conditioning of the paraspinal muscles. The exercise will be supplemented by visual biofeedback displayed on a computer screen. A detailed protocol will be followed, incorporating an individualized, diagnosis-based range of motion and progressive resistance overload. The supervised 16-week program consists of two sessions per week for the first nine weeks, followed by one session per week for the remaining seven weeks. Each session is supplemented with general exercises for the back and trunk muscles (e.g., lat pulldown, abdominal crunch). In addition, participants will receive at least five sessions of therapy, which may include joint mobilization, tissue treatment, stress management, and other therapeutic modalities.
Sponsors
Private Spine Center Dr. Alfen
University of Wuerzburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. chronic LBP for \> 3 months, defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain 2. seeking care in the facility of the study 3. doctoral assessment indicating symptoms related to disc herniations/protrusions and other specific conditions 4. moderate pain levels at the time of doctoral assessment
Exclusion criteria
1. acute low back pain (pain \< 3 months) 2. familiarity with the device (usage within the previous 12 months) 3. fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multifidus cross-sectional area (CSA; cm2) | Baseline, 3-week, 6-week, 9-week, 16-week | Multifidus muscle cross-sectional area measurements are obtained from ultrasound (US) from the L4/L5 spinal level (left and right) |
| Multifidus muscle thickness (MT; cm) | Baseline, 3-week, 6-week, 9-week, 16-week | Multifidus muscle thickness is measured with ultrasound (US) from the L4/L5 spinal level (left and right) |
| Multifidus echo intensity (EI; 0 -255 AU) | Baseline, 3-week, 6-week, 9-week, 16-week | Multifidus echo intensity (EI) is measured with ultrasound (US) from the cross-sectional area of the L4/L5 spinal level (left and right). EI is measured in arbitrary units (AU) via ImageJ on a scale from 0 (black) to 255 (white) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Isometric Lumbar Extensor Muscle Strength (Nm) | Baseline, 3-week, 6-week, 9-week, 16-week | Isometric lumbar extensor strength is measured with an isokinetic dynamometer as part of the Powerspine Back ILEX device. Measurements were taken at 39°, 30°, 24° and 15° in Newton meter (Nm). |
| Postural Alignment (°) | Baseline, 3-week, 6-week, 9-week, 16-week | Postural alignment will be measured with an infrared-based surface scanner (IDIAG M360). Included measures are angulations of 1) the thoracic spine, 2) the lumbar spine, and 3) the sacral inclination. |
| Mobility (°) | Baseline, 3-week, 6-week, 9-week, 16-week | Mobility is measured with an infrared-based surface scanner (IDIAG M360). Included measures are the mobility of the thoracic spine, the lumbar spine and the sacral inclination. |
| Stability (°) | Baseline, 3-week, 6-week, 9-week, 16-week | Stability is measured with an infrared-based surface scanner (IDIAG M360) and application of the Mathiass' Test. Included measures are angulations the thoracic spine, the lumbar spine, and the sacral inclination. |
| Pain intensity (0-100) | Baseline, 3-week, 6-week, 9-week, 16-week | Pain intensity is measured with the visual analog scale (VAS) on a rating scale from 0 (no pain) to 100 (maximum pain). |
| Muscle activity during static contraction in prone position (mV) | Baseline, 3-week, 6-week, 9-week, 16-week | Muscle activity during static contractin in prone position is measured at the L4/L5 level (bilateral) using surface electromyography. |
| Muscle activity during standing dynamic forward bend (mV) | Baseline, 3-week, 6-week, 9-week, 16-week | Muscle activity during during standing dynamic forward bend is measured at the L4/L5 level (bilateral) using surface electromyography. |
| Heart rate variability (HR, RSA, RMSSD) | Baseline, 3-week, 6-week, 9-week, 16-week | Measures of heart rate variability are obtained including heart rate (beats/minute), respiratory sinus arrhytmia (RSA) and root mean square of successive differences (RMSSD). |
| Muscle activity in sitting posture (mV) | Baseline, 3-week, 6-week, 9-week, 16-week | Sitting posture activity at the L4/L5 lumbar segment (bilateral) is measured using surface electromyography. |
| Disability (0-50) | Baseline, 3-week, 6-week, 9-week, 16-week | Disability in relation to LBP is measured with the Oswestry Disability Index (ODI). It includes 10 items (e.g., sitting, standing, personal care) with a range from 0-6 with higher scores indicating greater disability. |
| Health-related quality of life (QoL; 0-100) | Baseline, 3-week, 6-week, 9-week, 16-week | Health-related quality of life (QoL) is measured with the short-form survey 345 (SF-36). The survey consists of 8 domains assessing physical and mental sum scores (PCS and MCS). Scores in each domain can range from 0 (zero health) to 100 (perfect health). |
Countries
Germany
Outcome results
None listed