Low Back PainNCT06890052

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

A study testing Targeted exercise program and Targeted exercise as part of an integrative therapy program in people with Low Back Pain and Multifidus, run by University of Wuerzburg at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain, Multifidus, Exercise Therapy
What is being tested?: Targeted exercise program and Targeted exercise as part of an integrative therapy program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteGermany
Study dates: 1 Dec 2021to 24 Jun 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

University of Wuerzburg, Institute of Sports Science
Würzburg, Bavaria, 97072

Other trials in Germany

About this study

Official 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

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
Being tested: Targeted exercise program, Targeted exercise as part of an integrative therapy program
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Targeted exercise programOther
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 programOther
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 groups in NCT06890052
Study group	Role	What they receive
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. Receives: 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). Receives: Other: Targeted exercise as part of an integrative therapy program

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: Baseline, 3-week, 6-week, 9-week, 16-week

Secondary outcomes (11)

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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 3-week, 6-week, 9-week, 16-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202124 Jun 2025

First posted21 Mar 2025
Study start1 Dec 2021
Primary completion24 Dec 2024
Study completion24 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06890052
Sponsor's protocol ID: 01/2023
Status last verified: Mar 2025
First submitted: 11 Mar 2025
Last updated: 21 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41131158

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT06890052
Acronym / sponsor ID: 01/2023
Conditions: Low Back Pain, Multifidus, Exercise Therapy, Diagnostic Imaging
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 72 participants (actual)
Lead sponsor: University of WuerzburgUniversity, hospital or other
Collaborators: Private Spine Center Dr. Alfen
Study start: 1 Dec 2021 (actual)
Primary completion: 24 Dec 2024 (actual)
Study completion: 24 Jun 2025 (estimated)
First posted: 21 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ILEX-Only	Active comparator	Other: Targeted exercise programA 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.
ILEX supplemented with General Exercise and Manual Therapy	Experimental	Other: Targeted exercise as part of an integrative therapy programA 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).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Targeted exercise programParticipants 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.	Other	ILEX-Only
Targeted exercise as part of an integrative therapy programParticipants 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.	Other	ILEX supplemented with General Exercise and Manual Therapy

Primary outcome

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)
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)
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)

11 secondary outcomes

Pain intensity (0-100)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Disability (0-50)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Health-related quality of life (QoL; 0-100)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Isometric Lumbar Extensor Muscle Strength (Nm)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Postural Alignment (°)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Mobility (°)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Stability (°)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Muscle activity in sitting posture (mV)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Muscle activity during static contraction in prone position (mV)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Muscle activity during standing dynamic forward bend (mV)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week
Heart rate variability (HR, RSA, RMSSD)
Time frame: Baseline, 3-week, 6-week, 9-week, 16-week

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Derived from this study: PubMed 41131158Domokos 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.
Are the size and composition of the paraspinal muscles associated with low back pain? A systematic reviewLink provided by the sponsor.
Isolated Lumbar Extension Resistance Exercise in Limited Range of Motion for Patients with Lumbar Radiculopathy and Disk Herniation-Clinical Outcome and Influencing FactorsLink provided by the sponsor.
A review of the specificity of exercises designed for conditioning the lumbar extensorsLink provided by the sponsor.
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 TrialLink provided by the sponsor.
Individual participant dataSharing planned: No

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christoph Raschka, Prof. Dr. Dr. Dr. study director

University of Wuerzburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multifidus cross-sectional area (CSA; cm2) (time frame: Baseline, 3-week, 6-week, 9-week, 16-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06890052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.