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NCT Number: NCT06890052

Effects of Isolated Lumbar Extension Resistance Training Alone and in Combination with General Exercise and Manual Therapy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Low Back Pain Back Pain Diagnostic Imaging Exercise Therapy Multifidus Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wuerzburg, Institute of Sports Science

Würzburg, Bavaria, 97072, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic LBP for > 3 months, defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
  • seeking care in the facility of the study
  • doctoral assessment indicating symptoms related to disc herniations/protrusions and other specific conditions
  • moderate pain levels at the time of doctoral assessment

Exclusion criteria

  • acute low back pain (pain < 3 months)
  • familiarity with the device (usage within the previous 12 months)
  • fractures

Treatment and study plan

Targeted exercise program

Other

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.

Targeted exercise as part of an integrative therapy program

Other

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.

Primary outcomes

  1. Multifidus cross-sectional area (CSA; cm2)

    Time frame: 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)

  2. Multifidus muscle thickness (MT; cm)

    Time frame: 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)

  3. Multifidus echo intensity (EI; 0 -255 AU)

    Time frame: 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 outcomes

  1. Pain intensity (0-100)

    Time frame: 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).

  2. Disability (0-50)

    Time frame: 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.

  3. Health-related quality of life (QoL; 0-100)

    Time frame: 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).

  4. Isometric Lumbar Extensor Muscle Strength (Nm)

    Time frame: 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).

  5. Postural Alignment (°)

    Time frame: 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.

  6. Mobility (°)

    Time frame: 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.

  7. Stability (°)

    Time frame: 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.

  8. Muscle activity in sitting posture (mV)

    Time frame: Baseline, 3-week, 6-week, 9-week, 16-week

    Sitting posture activity at the L4/L5 lumbar segment (bilateral) is measured using surface electromyography.

  9. Muscle activity during static contraction in prone position (mV)

    Time frame: 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.

  10. Muscle activity during standing dynamic forward bend (mV)

    Time frame: 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.

  11. Heart rate variability (HR, RSA, RMSSD)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Collaborators

  • Private Spine Center Dr. Alfen

Registry information

Official study title

Effects of Isolated Lumbar Extension Resistance Exercise and the Impact of Additional Treatments on Multifidus Muscle Morphology, Strength, and Patient-Reported Outcomes in Chronic Low Back Pain and Radiculopathy Related to Spinal Disorders: a Closely-Monitored Clinical Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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