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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-06-24

Brief Summary

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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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Detailed Description

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Conditions

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Low Back Pain Multifidus Exercise Therapy Diagnostic Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ILEX-Only

A supervised 16-week program consisting of 25 sessions of isolated lumbar extension resistance exercise (ILEX) using a new machine-based device. The program includes two sessions per week for the first nine weeks, followed by one session per week for the remaining seven weeks.

Group Type ACTIVE_COMPARATOR

Targeted exercise program

Intervention Type 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.

ILEX supplemented with General Exercise and Manual Therapy

A supervised 16-week program consisting of 25 sessions of isolated lumbar extension resistance exercise (ILEX) using a new machine-based device. The program includes 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 four general strengthening exercises. Additionally, patients receive manual therapy (MT).

Group Type EXPERIMENTAL

Targeted exercise as part of an integrative therapy program

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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