Clinical trial NCT06890052: Effects of Isolated Lumbar Extension Resistance Training Alone and in Combination with General Exercise and Manual Therapy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Multifidus
Exercise Therapy
Diagnostic Imaging
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Private Spine Center Dr. Alfen
First posted: 2025-03-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Multifidus cross-sectional area (CSA; cm2)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Multifidus muscle thickness (MT; cm)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Multifidus echo intensity (EI; 0 -255 AU)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
Secondary outcomes:
measure: Pain intensity (0-100)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Disability (0-50)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Health-related quality of life (QoL; 0-100)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Isometric Lumbar Extensor Muscle Strength (Nm)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Postural Alignment (°)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Mobility (°)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Stability (°)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Muscle activity in sitting posture (mV)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Muscle activity during static contraction in prone position (mV)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Muscle activity during standing dynamic forward bend (mV)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
measure: Heart rate variability (HR, RSA, RMSSD)
timeFrame: Baseline, 3-week, 6-week, 9-week, 16-week
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg, Institute of Sports Science
state: Bavaria
Study officials:
affiliation: University of Wuerzburg
name: Christoph Raschka, Prof. Dr. Dr. Dr.
role: STUDY_DIRECTOR
References: