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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain; Diagnostic Imaging; Exercise Therapy; Multifidus
• Intervention / Treatment: Other: Targeted exercise program; Other: Targeted exercise as part of an integrative therapy program

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97072
      • University of Wuerzburg, Institute of Sports Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multifidus cross-sectional area (CSA; cm2)	Multifidus muscle cross-sectional area measurements are obtained from ultrasound (US) from the L4/L5 spinal level (left and right)	Baseline, 3-week, 6-week, 9-week, 16-week
Multifidus muscle thickness (MT; cm)	Multifidus muscle thickness is measured with ultrasound (US) from the L4/L5 spinal level (left and right)	Baseline, 3-week, 6-week, 9-week, 16-week
Multifidus echo intensity (EI; 0 -255 AU)	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)	Baseline, 3-week, 6-week, 9-week, 16-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (0-100)	Pain intensity is measured with the visual analog scale (VAS) on a rating scale from 0 (no pain) to 100 (maximum pain).	Baseline, 3-week, 6-week, 9-week, 16-week
Disability (0-50)	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.	Baseline, 3-week, 6-week, 9-week, 16-week
Health-related quality of life (QoL; 0-100)	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).	Baseline, 3-week, 6-week, 9-week, 16-week
Isometric Lumbar Extensor Muscle Strength (Nm)	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).	Baseline, 3-week, 6-week, 9-week, 16-week
Postural Alignment (°)	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.	Baseline, 3-week, 6-week, 9-week, 16-week
Mobility (°)	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.	Baseline, 3-week, 6-week, 9-week, 16-week
Stability (°)	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.	Baseline, 3-week, 6-week, 9-week, 16-week
Muscle activity in sitting posture (mV)	Sitting posture activity at the L4/L5 lumbar segment (bilateral) is measured using surface electromyography.	Baseline, 3-week, 6-week, 9-week, 16-week
Muscle activity during static contraction in prone position (mV)	Muscle activity during static contractin in prone position is measured at the L4/L5 level (bilateral) using surface electromyography.	Baseline, 3-week, 6-week, 9-week, 16-week
Muscle activity during standing dynamic forward bend (mV)	Muscle activity during during standing dynamic forward bend is measured at the L4/L5 level (bilateral) using surface electromyography.	Baseline, 3-week, 6-week, 9-week, 16-week
Heart rate variability (HR, RSA, RMSSD)	Measures of heart rate variability are obtained including heart rate (beats/minute), respiratory sinus arrhytmia (RSA) and root mean square of successive differences (RMSSD).	Baseline, 3-week, 6-week, 9-week, 16-week

Collaborators and Investigators

• Sponsor: University of Wuerzburg
• Collaborators: Private Spine Center Dr. Alfen
• Investigators: Study Director: Christoph Raschka, Prof. Dr. Dr. Dr., University of Wuerzburg

Publications and helpful links

Helpful Links

• Are the size and composition of the paraspinal muscles associated with low back pain? A systematic review
• Isolated Lumbar Extension Resistance Exercise in Limited Range of Motion for Patients with Lumbar Radiculopathy and Disk Herniation-Clinical Outcome and Influencing Factors
• A review of the specificity of exercises designed for conditioning the lumbar extensors
• The Effects of Combined Motor Control and Isolated Extensor Strengthening versus General Exercise on Paraspinal Muscle Morphology, Composition, and Function in Patients with Chronic Low Back Pain: A Randomized Controlled Trial

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 24, 2024
• Study Completion (Estimated): June 24, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 01/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No