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

Condition(s) studied

Investigational drug(s) / intervention(s)

Targeted exercise program: 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: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (1)

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