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

University of Wuerzburg

Status: Active, not recruiting

Conditions: Exercise Therapy; Diagnostic Imaging; Multifidus; Low Back Pain

Treatments: Other: Targeted exercise program; Other: Targeted exercise as part of an integrative therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT06890052

01/2023

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

ILEX-Only

Active Comparator group

Description:

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.

Treatment:

Other: Targeted exercise program

ILEX supplemented with General Exercise and Manual Therapy

Experimental group

Description:

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).

Treatment:

Other: Targeted exercise as part of an integrative therapy program