Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)

NCT05706103 | Recruiting

• 2 other identifiers: BC-05152U1111-1283-4631
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise therapy has been shown to be effective in decreasing pain and improving function for patients with recurrent low back pain (LBP). Research on the mechanisms that trigger and/or underlie the effects of exercise therapy on LBP problems is of critical importance for the prevention of recurring or persistence of this costly and common condition. One factor that seems to be crucial within this context is the dysfunction of the back muscles. Recent pioneering results have shown that individuals with recurring episodes of LBP have specific dysfunctions of these muscles (peripheral changes) and also dysfunctions at the cortical level (central changes). This work provides the foundation to take a fresh look at the interplay between peripheral and central aspects, and its potential involvement in exercise therapy. The current project will draw on this opportunity to address the following research questions: What are the immediate (after a single session) and the long-term effects (after 18 repeated sessions) of exercise training on: (1) back muscle structure; (2) back muscle function; (3) the structure of the brain; (4) and functional connectivity of the brain. This research project also aims to examine whether the effects are dependent on how the training was performed. Therefore a specific versus a general exercise program will be compared.

Conditions

Low Back Pain, Recurrent

Keywords

low back pain; motor control; exercise; randomized controlled trial

Outcome Measures

Primary Outcomes (8)

• Brain macro-structure

  Whole brain T1-weighted structural MRI will be acquired.

  Baseline

• Brain macro-structure

  Whole brain T1-weighted structural MRI will be acquired.

  After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks

• Brain macro-structure

  Whole brain T1-weighted structural MRI will be acquired.

  After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks

• Brain macro-structure

  Whole brain T1-weighted structural MRI will be acquired.

  At 3 months follow-up

• Brain micro-structure

  Whole-brain T2-weighted images will be obtained.

  Baseline

• Brain micro-structure

  Whole-brain T2-weighted images will be obtained.

  After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks

• Brain micro-structure

  Whole-brain T2-weighted images will be obtained.

  After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks

• Brain micro-structure

  Whole-brain T2-weighted images will be obtained.

  At 3 months follow-up

Secondary Outcomes (78)

• Functional brain connectivity

  Baseline

• Functional brain connectivity

  After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks

• Functional brain connectivity

  After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks

• Functional brain connectivity

  At 3 months follow-up

• Lumbar muscle structure

  Baseline

Study Arms (2)

Specific skilled motor training

EXPERIMENTAL

13 weeks of treatment, with 18 supervised treatment sessions in combination with an individualized home-exercise program. This group will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18).

Behavioral: Specific skilled motor training

General extension training

ACTIVE COMPARATOR

13 weeks of treatment, with 18 supervised treatment sessions in combination with an individualized home-exercise program. This group will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18).

Behavioral: General extension training

Interventions

Specific skilled motor training BEHAVIORAL

Participants allocated to the skilled motor training group will receive sensorimotor training of the intrinsic muscles of the lumbopelvic region, namely the multifidus, transversus abdominis, and pelvic floor muscles.

Specific skilled motor training

General extension training BEHAVIORAL

Participants allocated to the general extension training group will receive general training exercises using the David Back equipment from the Back Unit at Ghent University Hospital

General extension training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of non-specific recurrent LBP with the first onset being at least 6 months ago
• At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
• Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
• During remission the NRS intensity for LBP should be 0.
• LBP should be of that severity that it limits activities of daily living
• LBP should be of that severity that a (para)medic has been consulted at least once regarding the complaints
• Flexion pattern of LBP

You may not qualify if:

• Chronic LBP (i.e. duration remission \<1 month)
• Subacute LBP (i.e. first onset between 3 and 6 months ago)
• Acute (i.e. first onset \<3 months ago) LBP
• Specific LBP (i.e. LBP proportionate to an identifiable pathology, e.g. lumbar radiculopathy)
• Patients with neuropathic pain
• Patients with chronic widespread pain as defined by the criteria of the 1990 ACR (i.e. fibromyalgia)
• A lifetime history of spinal traumata (e.g. whiplash), surgery (e.g. laminectomy) or deformations (e.g. scoliosis)
• A lifetime history of respiratory, metabolic, neurologic, cardiovascular, inflammatory, orthopedic or rheumatologic diseases
• Concomitant therapies (i.e. rehabilitation, alternative medicine or therapies)
• Contra-indications for MRI (e.g. suffering from claustrophobia, the presence of metallic foreign material in the body, BMI \>30kg/m²)
• Professional athletes
• Pregnant women
• Breastfeeding women
• Women given birth in the last year before enrolment

Sponsors & Collaborators

• University Ghent: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

Ghent University, vakgroep revalidatiewetenschappen

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Related Publications (45)

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MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica van Oosterwijck, Prof

  Ghent University, Pain in Motion

  STUDY DIRECTOR

Central Study Contacts

Jessica van Oosterwijck, Prof

CONTACT

+3293326919; Jessica.VanOosterwijck@UGent.be

Lieven Danneels, Prof

CONTACT

+32 9 332 26 35; Lieven.Danneels@UGent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study model is parallel. Participants experiencing recurrent LBP patients will be randomly allocated (1:1) to receive either specific skilled motor training or general extension training (i.e. parallel study model). Both groups will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18) (i.e. cross-over study model).

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 31, 2023
• Study Start: January 4, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)