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

Official title

Efficacy of Specific Skilled Motor Versus General Exercise Training on Peripheral Muscle and Central Brain Alterations in Patients with Recurrent Low Back Pain

Overview

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.

Detailed description

Although the cause of persistent non-specific LBP remains unknown, structural and functional alterations of the brain and paravertebral muscles have been proposed as underlying mechanisms. As it is hypothesized that these alterations contribute to, or maintain non-specific LBP, exercise therapy is a key element in the rehabilitation of reoccurring LBP. Specific training of sensorimotor control of the lumbopelvic region (i.e. specific skilled motor training) has shown to decrease pain and disability in patients with LBP, but has not been found superior to other forms of exercise training regarding improvements in clinical outcome measures. On the other hand, this type of training seems to differentially impact the recruitment of the back muscles compared to general exercise training. However, research using multiple treatment sessions and including follow-up outcome assessments is scarce. Furthermore, it is unknown if improvements may be attributed to measurable peripheral changes in the muscle and/or central neural adaptations in the brain. The primary aim of this study is to examine the short and long-term effects of specific skilled motor control training versus unspecific general extension training on pain, functional disability, brain structure/function and muscle structure/function in recurrent LBP patients.

Method: In this double-blind, randomized controlled clinical trial 62 recurrent LBP patients will be randomly allocated (1:1) to receive either specific skilled motor training (i.e. the experimental group) or general extension training (i.e. control group). Each training group will receive 13 weeks of treatment, during which a total of 18 supervised treatment sessions will be delivered in combination with an individualized home-exercise program. 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). Primary outcome measures include: LBP-related pain and disability (RMDQ, NRS and Margolis pain diagram), lumbar muscle structure and function (Dixon MRI and mf-MRI) and brain structure and function (MRI, DTI and fMRI). Secondary measures include: lumbopelvic control and proprioception (thoracolumbar dissociation test and position-reposition test), trunk muscle activity (RAM and QFRT) and psychosocial factors, including measures of physical activity (IPAQ-LF, SF-36), pain cognitions and perceptions (PCS, PCI and PVAQ), anxiety and depression (HADS), and kinesiophobia (TSK). Experimental data collection will be performed at baseline, immediately following the low-load training (i.e. after the 9th supervised treatment session), following the high-load training (i.e. after the 18th supervised treatment session), and at 3 months follow-up. Experimental data collection will comprise of magnetic resonance imaging of the brain and trunk muscles, clinical assessments assessing muscle function, and a battery of questionnaires evaluating psychosocial factors.

Interventions

• Behavioral Specific skilled motor training
  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.
• Behavioral General extension training
  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

Primary outcome measures

• Brain macro-structure [Time frame: Baseline]
• Brain macro-structure [Time frame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks]
• Brain macro-structure [Time frame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks]
• Brain macro-structure [Time frame: At 3 months follow-up]
• Brain micro-structure [Time frame: Baseline]
• Brain micro-structure [Time frame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks]
• Brain micro-structure [Time frame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks]
• Brain micro-structure [Time frame: At 3 months follow-up]

Secondary outcome measures (12)

• Functional brain connectivity [Time frame: Baseline]
• Functional brain connectivity [Time frame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks]
• Functional brain connectivity [Time frame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks]
• Functional brain connectivity [Time frame: At 3 months follow-up]
• Lumbar muscle structure [Time frame: Baseline]
• Lumbar muscle structure [Time frame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks]
• Lumbar muscle structure [Time frame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks]
• Lumbar muscle structure [Time frame: At 3 months follow-up]
• Lumbar muscle function [Time frame: Baseline]
• Lumbar muscle function [Time frame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks]
• Lumbar muscle function [Time frame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks]
• Lumbar muscle function [Time frame: At 3 months follow-up.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Belgium · 1 center

• Ghent University, vakgroep revalidatiewetenschappen — Ghent

Publications

• Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. PMID 29573870
• Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26. PMID 29480409
• Deyo RA. Diagnostic evaluation of LBP: reaching a specific diagnosis is often impossible. Arch Intern Med. 2002 Jul 8;162(13):1444-7; discussion 1447-8. doi: 10.1001/archinte.162.13.1444. No abstract available. PMID 12090877
• Iizuka Y, Iizuka H, Mieda T, Tsunoda D, Sasaki T, Tajika T, Yamamoto A, Takagishi K. Prevalence of Chronic Nonspecific Low Back Pain and Its Associated Factors among Middle-Aged and Elderly People: An Analysis Based on Data from a Musculoskeletal Examination in Japan. Asian Spine J. 2017 Dec;11(6):989-997. doi: 10.4184/asj.2017.11.6.989. Epub 2017 Dec 7. PMID 29279756
• Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013 Jan;17(1):5-15. doi: 10.1002/j.1532-2149.2012.00170.x. Epub 2012 May 28. PMID 22641374
• da C Menezes Costa L, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LO. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012 Aug 7;184(11):E613-24. doi: 10.1503/cmaj.111271. Epub 2012 May 14. PMID 22586331
• da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of Recurrence of Low Back Pain: A Systematic Review. J Orthop Sports Phys Ther. 2017 May;47(5):305-313. doi: 10.2519/jospt.2017.7415. Epub 2017 Mar 29. PMID 28355981
• Goubert D, Meeus M, Willems T, De Pauw R, Coppieters I, Crombez G, Danneels L. The association between back muscle characteristics and pressure pain sensitivity in low back pain patients. Scand J Pain. 2018 Apr 25;18(2):281-293. doi: 10.1515/sjpain-2017-0142. PMID 29794309

Identifiers

NCT: NCT05706103 · BC-05152 · U1111-1283-4631

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗