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

NCT06890052 | Active Not Recruiting

• 1 other identifier: 01/2023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Multifidus; Exercise Therapy; Diagnostic Imaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Pain intensity (0-100)

  Baseline, 3-week, 6-week, 9-week, 16-week

• Disability (0-50)

  Baseline, 3-week, 6-week, 9-week, 16-week

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

  Baseline, 3-week, 6-week, 9-week, 16-week

• Isometric Lumbar Extensor Muscle Strength (Nm)

  Baseline, 3-week, 6-week, 9-week, 16-week

• Postural Alignment (°)

  Baseline, 3-week, 6-week, 9-week, 16-week

Study Arms (2)

ILEX-Only

ACTIVE COMPARATOR

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

ILEX supplemented with General Exercise and Manual Therapy

EXPERIMENTAL

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

Interventions

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.

ILEX-Only

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.

ILEX supplemented with General Exercise and Manual Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wuerzburg: lead
• Private Spine Center Dr. Alfen: collaborator

Study Sites (1)

University of Wuerzburg, Institute of Sports Science

Würzburg, Bavaria, 97072, Germany

Location

Related Publications (1)

• Domokos B, Domokos J, Andersson G, Mannel S, Weigel LM, Koch HJ, Wallmann-Sperlich B, Raschka C, Spang C. Isolated lumbar extension exercise alone or in a multimodal program for low back pain and radiculopathy: a non-randomized controlled trial. Sci Rep. 2025 Oct 23;15(1):37157. doi: 10.1038/s41598-025-22452-x.

  PMID: 41131158 DERIVED

Related 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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Raschka, Prof. Dr. Dr. Dr.

  University of Wuerzburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Coordinator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 21, 2025
• Study Start: December 1, 2021
• Primary Completion: December 24, 2024
• Study Completion: June 24, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)