Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05706103
Other study ID # B670201420984
Secondary ID U1111-1283-4631
Status Recruiting
Phase N/A
First received
Last updated
Start date January 4, 2021
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source University Ghent
Contact Jessica van Oosterwijck, Prof
Phone +3293326919
Email Jessica.VanOosterwijck@UGent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Intervention

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.
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

Locations

Country Name City State
Belgium Ghent University, vakgroep revalidatiewetenschappen Ghent Oost-Vlaanderen

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (45)

Agten A, Stevens S, Verbrugghe J, Timmermans A, Vandenabeele F. Biopsy samples from the erector spinae of persons with nonspecific chronic low back pain display a decrease in glycolytic muscle fibers. Spine J. 2020 Feb;20(2):199-206. doi: 10.1016/j.spinee.2019.09.023. Epub 2019 Sep 27. — View Citation

Boyke J, Driemeyer J, Gaser C, Buchel C, May A. Training-induced brain structure changes in the elderly. J Neurosci. 2008 Jul 9;28(28):7031-5. doi: 10.1523/JNEUROSCI.0742-08.2008. — View Citation

Brumagne S, Diers M, Danneels L, Moseley GL, Hodges PW. Neuroplasticity of Sensorimotor Control in Low Back Pain. J Orthop Sports Phys Ther. 2019 Jun;49(6):402-414. doi: 10.2519/jospt.2019.8489. — View Citation

Cagnie B, Dhooge F, Schumacher C, De Meulemeester K, Petrovic M, van Oosterwijck J, Danneels L. Fiber Typing of the Erector Spinae and Multifidus Muscles in Healthy Controls and Back Pain Patients: A Systematic Literature Review. J Manipulative Physiol Ther. 2015 Nov-Dec;38(9):653-663. doi: 10.1016/j.jmpt.2015.10.004. Epub 2015 Nov 5. — View Citation

Coppieters I, Meeus M, Kregel J, Caeyenberghs K, De Pauw R, Goubert D, Cagnie B. Relations Between Brain Alterations and Clinical Pain Measures in Chronic Musculoskeletal Pain: A Systematic Review. J Pain. 2016 Sep;17(9):949-62. doi: 10.1016/j.jpain.2016.04.005. Epub 2016 Jun 3. — View Citation

D'hooge R, Cagnie B, Crombez G, Vanderstraeten G, Achten E, Danneels L. Lumbar muscle dysfunction during remission of unilateral recurrent nonspecific low-back pain: evaluation with muscle functional MRI. Clin J Pain. 2013 Mar;29(3):187-94. doi: 10.1097/AJP.0b013e31824ed170. — View Citation

D'hooge R, Cagnie B, Crombez G, Vanderstraeten G, Dolphens M, Danneels L. Increased intramuscular fatty infiltration without differences in lumbar muscle cross-sectional area during remission of unilateral recurrent low back pain. Man Ther. 2012 Dec;17(6):584-8. doi: 10.1016/j.math.2012.06.007. Epub 2012 Jul 10. — View Citation

D'hooge R, Hodges P, Tsao H, Hall L, Macdonald D, Danneels L. Altered trunk muscle coordination during rapid trunk flexion in people in remission of recurrent low back pain. J Electromyogr Kinesiol. 2013 Feb;23(1):173-81. doi: 10.1016/j.jelekin.2012.09.003. Epub 2012 Oct 15. — View Citation

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. — View Citation

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. — View Citation

Danneels LA, Vanderstraeten GG, Cambier DC, Witvrouw EE, De Cuyper HJ. CT imaging of trunk muscles in chronic low back pain patients and healthy control subjects. Eur Spine J. 2000 Aug;9(4):266-72. doi: 10.1007/s005860000190. — View Citation

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. — View Citation

Draganski B, Gaser C, Busch V, Schuierer G, Bogdahn U, May A. Neuroplasticity: changes in grey matter induced by training. Nature. 2004 Jan 22;427(6972):311-2. doi: 10.1038/427311a. No abstract available. — View Citation

Ebenbichler GR, Oddsson LI, Kollmitzer J, Erim Z. Sensory-motor control of the lower back: implications for rehabilitation. Med Sci Sports Exerc. 2001 Nov;33(11):1889-98. doi: 10.1097/00005768-200111000-00014. — View Citation

Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21. — View Citation

Geisser ME, Ranavaya M, Haig AJ, Roth RS, Zucker R, Ambroz C, Caruso M. A meta-analytic review of surface electromyography among persons with low back pain and normal, healthy controls. J Pain. 2005 Nov;6(11):711-26. doi: 10.1016/j.jpain.2005.06.008. — View Citation

Goossens N, Rummens S, Janssens L, Caeyenberghs K, Brumagne S. Association Between Sensorimotor Impairments and Functional Brain Changes in Patients With Low Back Pain: A Critical Review. Am J Phys Med Rehabil. 2018 Mar;97(3):200-211. doi: 10.1097/PHM.0000000000000859. — View Citation

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. — View Citation

Goubert D, Oosterwijck JV, Meeus M, Danneels L. Structural Changes of Lumbar Muscles in Non-specific Low Back Pain: A Systematic Review. Pain Physician. 2016 Sep-Oct;19(7):E985-E1000. — View Citation

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. — View Citation

Hodges PW, Moseley GL. Pain and motor control of the lumbopelvic region: effect and possible mechanisms. J Electromyogr Kinesiol. 2003 Aug;13(4):361-70. doi: 10.1016/s1050-6411(03)00042-7. — View Citation

Hodges PW. Core stability exercise in chronic low back pain. Orthop Clin North Am. 2003 Apr;34(2):245-54. doi: 10.1016/s0030-5898(03)00003-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kilgour AH, Todd OM, Starr JM. A systematic review of the evidence that brain structure is related to muscle structure and their relationship to brain and muscle function in humans over the lifecourse. BMC Geriatr. 2014 Jul 10;14:85. doi: 10.1186/1471-2318-14-85. — View Citation

Knox MF, Chipchase LS, Schabrun SM, Romero RJ, Marshall PWM. Anticipatory and compensatory postural adjustments in people with low back pain: a systematic review and meta-analysis. Spine J. 2018 Oct;18(10):1934-1949. doi: 10.1016/j.spinee.2018.06.008. Epub 2018 Jun 12. — View Citation

Kregel J, Meeus M, Malfliet A, Dolphens M, Danneels L, Nijs J, Cagnie B. Structural and functional brain abnormalities in chronic low back pain: A systematic review. Semin Arthritis Rheum. 2015 Oct;45(2):229-37. doi: 10.1016/j.semarthrit.2015.05.002. Epub 2015 May 16. — View Citation

Liu KP, Chan CC, Lee TM, Hui-Chan CW. Mental imagery for promoting relearning for people after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Sep;85(9):1403-8. doi: 10.1016/j.apmr.2003.12.035. — View Citation

Macedo LG, Saragiotto BT, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Maher CG. Motor control exercise for acute non-specific low back pain. Cochrane Database Syst Rev. 2016 Feb 10;2(2):CD012085. doi: 10.1002/14651858.CD012085. — View Citation

Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Influence of paravertebral muscles training on brain plasticity and postural control in chronic low back pain. Scand J Pain. 2016 Jul;12:74-83. doi: 10.1016/j.sjpain.2016.03.005. Epub 2016 May 11. — View Citation

Moseley GL, Flor H. Targeting cortical representations in the treatment of chronic pain: a review. Neurorehabil Neural Repair. 2012 Jul-Aug;26(6):646-52. doi: 10.1177/1545968311433209. Epub 2012 Feb 13. — View Citation

Panjabi M, Abumi K, Duranceau J, Oxland T. Spinal stability and intersegmental muscle forces. A biomechanical model. Spine (Phila Pa 1976). 1989 Feb;14(2):194-200. doi: 10.1097/00007632-198902000-00008. — View Citation

Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001. — View Citation

Panjabi MM. The stabilizing system of the spine. Part II. Neutral zone and instability hypothesis. J Spinal Disord. 1992 Dec;5(4):390-6; discussion 397. doi: 10.1097/00002517-199212000-00002. — View Citation

Prins MR, Griffioen M, Veeger TTJ, Kiers H, Meijer OG, van der Wurff P, Bruijn SM, van Dieen JH. Evidence of splinting in low back pain? A systematic review of perturbation studies. Eur Spine J. 2018 Jan;27(1):40-59. doi: 10.1007/s00586-017-5287-0. Epub 2017 Sep 12. — View Citation

Ranger TA, Cicuttini FM, Jensen TS, Peiris WL, Hussain SM, Fairley J, Urquhart DM. Are the size and composition of the paraspinal muscles associated with low back pain? A systematic review. Spine J. 2017 Nov;17(11):1729-1748. doi: 10.1016/j.spinee.2017.07.002. Epub 2017 Jul 26. — View Citation

Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004. — View Citation

Scholz J, Klein MC, Behrens TE, Johansen-Berg H. Training induces changes in white-matter architecture. Nat Neurosci. 2009 Nov;12(11):1370-1. doi: 10.1038/nn.2412. Epub 2009 Oct 11. — View Citation

Taubert M, Draganski B, Anwander A, Muller K, Horstmann A, Villringer A, Ragert P. Dynamic properties of human brain structure: learning-related changes in cortical areas and associated fiber connections. J Neurosci. 2010 Sep 1;30(35):11670-7. doi: 10.1523/JNEUROSCI.2567-10.2010. — View Citation

Taubert M, Lohmann G, Margulies DS, Villringer A, Ragert P. Long-term effects of motor training on resting-state networks and underlying brain structure. Neuroimage. 2011 Aug 15;57(4):1492-8. doi: 10.1016/j.neuroimage.2011.05.078. Epub 2011 Jun 7. — View Citation

Tavor I, Botvinik-Nezer R, Bernstein-Eliav M, Tsarfaty G, Assaf Y. Short-term plasticity following motor sequence learning revealed by diffusion magnetic resonance imaging. Hum Brain Mapp. 2020 Feb 1;41(2):442-452. doi: 10.1002/hbm.24814. Epub 2019 Oct 9. — View Citation

Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004. — View Citation

Tsao H, Galea MP, Hodges PW. Driving plasticity in the motor cortex in recurrent low back pain. Eur J Pain. 2010 Sep;14(8):832-9. doi: 10.1016/j.ejpain.2010.01.001. Epub 2010 Feb 23. — View Citation

Yuan C, Shi H, Pan P, Dai Z, Zhong J, Ma H, Sheng L. Gray Matter Abnormalities Associated With Chronic Back Pain: A Meta-Analysis of Voxel-based Morphometric Studies. Clin J Pain. 2017 Nov;33(11):983-990. doi: 10.1097/AJP.0000000000000489. — View Citation

* Note: There are 45 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Brain macro-structure Whole brain T1-weighted structural MRI will be acquired. Baseline
Primary 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
Primary 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
Primary Brain macro-structure Whole brain T1-weighted structural MRI will be acquired. At 3 months follow-up
Primary Brain micro-structure Whole-brain T2-weighted images will be obtained. Baseline
Primary 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
Primary 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
Primary Brain micro-structure Whole-brain T2-weighted images will be obtained. At 3 months follow-up
Secondary Functional brain connectivity Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing. Baseline
Secondary Functional brain connectivity Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Functional brain connectivity Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Functional brain connectivity Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing. At 3 months follow-up
Secondary Lumbar muscle structure T1-weighted Dixon MRI will be performed. Baseline
Secondary Lumbar muscle structure T1-weighted Dixon MRI will be performed. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Lumbar muscle structure T1-weighted Dixon MRI will be performed. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Lumbar muscle structure T1-weighted Dixon MRI will be performed. At 3 months follow-up
Secondary Lumbar muscle function T2-weighted mf-MRI will be conducted. Baseline
Secondary Lumbar muscle function T2-weighted mf-MRI will be conducted. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Lumbar muscle function T2-weighted mf-MRI will be conducted. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Lumbar muscle function T2-weighted mf-MRI will be conducted. At 3 months follow-up.
Secondary Lumbopelvic control Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction. Baseline
Secondary Lumbopelvic control Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Lumbopelvic control Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Lumbopelvic control Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction. At 3 months follow-up.
Secondary Lumbopelvic proprioception To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined. Baseline
Secondary Lumbopelvic proprioception To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Lumbopelvic proprioception To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Lumbopelvic proprioception To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined. At 3 months follow-up.
Secondary Anticipatory postural adjustments To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM). Baseline
Secondary Anticipatory postural adjustments To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM). After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Anticipatory postural adjustments To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM). After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Anticipatory postural adjustments To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM). At 3 months follow-up
Secondary Compensatory postural adjustments To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT). Baseline
Secondary Compensatory postural adjustments To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT). After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Compensatory postural adjustments To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT). After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Compensatory postural adjustments To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT). At 3 months follow-up
Secondary Nociceptive flexion reflex - threshold The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris. Baseline
Secondary Nociceptive flexion reflex - threshold The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Nociceptive flexion reflex - threshold The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Nociceptive flexion reflex - threshold The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris. At 3 months follow-up
Secondary Nociceptive flexion reflex - temporal summation Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times. Baseline
Secondary Nociceptive flexion reflex - temporal summation Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Nociceptive flexion reflex - temporal summation Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Nociceptive flexion reflex - temporal summation Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times. At 3 months follow-up
Secondary Conditioned pain modulation The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side. Baseline
Secondary Conditioned pain modulation The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Conditioned pain modulation The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Conditioned pain modulation The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side. At 3 months follow-up
Secondary Anxiety and depression Hospital Anxiety and depression scale (HADS) Baseline
Secondary Anxiety and depression Hospital Anxiety and depression scale (HADS) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Anxiety and depression Hospital Anxiety and depression scale (HADS) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Anxiety and depression Hospital Anxiety and depression scale (HADS) At 3 months follow-up
Secondary Physical activity International physical activity questionnaire - long form (IPAQ-LF) Baseline
Secondary Physical activity International physical activity questionnaire - long form (IPAQ-LF) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Physical activity International physical activity questionnaire - long form (IPAQ-LF) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Physical activity International physical activity questionnaire - long form (IPAQ-LF) At 3 months follow-up.
Secondary Pain coping Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS) Baseline
Secondary Pain coping Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Pain coping Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Pain coping Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS) At 3 months follow-up
Secondary Pain catastrophizing Pain Catastrophizing Scale (PCS) Baseline
Secondary Pain catastrophizing Pain Catastrophizing Scale (PCS) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Pain catastrophizing Pain Catastrophizing Scale (PCS) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Pain catastrophizing Pain Catastrophizing Scale (PCS) At 3 months follow-up
Secondary Pain vigilance and awareness Pain vigilance and awareness questionnaire (PVAQ) Baseline
Secondary Pain vigilance and awareness Pain vigilance and awareness questionnaire (PVAQ) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Pain vigilance and awareness Pain vigilance and awareness questionnaire (PVAQ) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Pain vigilance and awareness Pain vigilance and awareness questionnaire (PVAQ) At 3 months follow-up
Secondary Kinesiophobia Tampa Scale for Kinesiophobia (TSK) Baseline
Secondary Kinesiophobia Tampa Scale for Kinesiophobia (TSK) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Kinesiophobia Tampa Scale for Kinesiophobia (TSK) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Kinesiophobia Tampa Scale for Kinesiophobia (TSK) At 3 months follow-up
Secondary Health status Short Form Health Survey-36 items (SF-36) Baseline
Secondary Health status Short Form Health Survey-36 items (SF-36) After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Health status Short Form Health Survey-36 items (SF-36) After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Health status Short Form Health Survey-36 items (SF-36) At 3 months follow-up
Secondary Low back pain related pain LBP related pain intensity will be evaluated by using an 11 point NRS Baseline
Secondary Low back pain related pain LBP related pain intensity will be evaluated by using an 11 point NRS After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Low back pain related pain LBP related pain intensity will be evaluated by using an 11 point NRS After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Low back pain related pain LBP related pain intensity will be evaluated by using an 11 point NRS At 3 months follow-up
Secondary Low back pain related disability The Roland Morris Disability Questionnaire will be used to evaluate disability. Baseline
Secondary Low back pain related disability The Roland Morris Disability Questionnaire will be used to evaluate disability. After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Secondary Low back pain related disability The Roland Morris Disability Questionnaire will be used to evaluate disability. After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Secondary Low back pain related disability The Roland Morris Disability Questionnaire will be used to evaluate disability. At 3 months follow-up
Secondary Low back pain recurrence Self-report via telephone interview: (1) the number of episode(s), (2) the duration of the LBP episode(s), (3) pain intensity, measured with three NRS for average-, worst- and current pain during the LBP episode(s), (4) location and quality of pain (i.e. sharp, burning, etc. sensation), (5) subjects opinion about what caused the new episode of LBP, (6) degree of impairments in daily life activities due to the LBP, (7) whether participants sought treatment (i.e. physiotherapist, general practitioner, etc.) and (8) strategies to cope with the new LBP episode. At 6 months follow-up
Secondary Low back pain recurrence Self-report via telephone interview: (1) the number of episode(s), (2) the duration of the LBP episode(s), (3) pain intensity, measured with three NRS for average-, worst- and current pain during the LBP episode(s), (4) location and quality of pain (i.e. sharp, burning, etc. sensation), (5) subjects opinion about what caused the new episode of LBP, (6) degree of impairments in daily life activities due to the LBP, (7) whether participants sought treatment (i.e. physiotherapist, general practitioner, etc.) and (8) strategies to cope with the new LBP episode. At 12 months follow-up
See also
  Status Clinical Trial Phase
Completed NCT03852667 - The Effect of Secondary Prevention in Patients With Recurrent Low Back Pain N/A
Completed NCT02235207 - Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain N/A
Terminated NCT00973024 - A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain Phase 2
Active, not recruiting NCT00908102 - Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials N/A
Completed NCT04979403 - Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial? N/A
Completed NCT05223946 - Treatment and Companion Diagnostics of Lower Back Pain Using SCENAR and Passive Medical Radiometry (MWR) N/A
Recruiting NCT03680287 - Effects of Sleep Disruption on Drug Response Phase 2
Not yet recruiting NCT04542798 - CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting N/A
Recruiting NCT05840302 - Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain N/A
Completed NCT06143319 - Structural White and Gray Matter Correlates of Impaired Muscle Control and Deficient Pain Processing
Completed NCT00361270 - Treatment of Veterans With Chronic Low Back Pain N/A
Completed NCT03328689 - Back2LiveWell: Community Based Prevention of Back Pain Flare-ups N/A
Recruiting NCT05350254 - Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain N/A
Completed NCT04592094 - Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain N/A
Completed NCT04436003 - GDS Muscle and Articulation Chain Treatment for Chronic LBP and Spinal Stenosis N/A
Completed NCT04943640 - The Additional Effect of Different Taping Applications in Patients With Lumbar Radiculopathy N/A
Completed NCT05682287 - The Effect of Radiofrequency of 448 kHz on Pain and Function N/A
Recruiting NCT04074798 - Hyperventilation in Patients With Chronic Low Back Pain N/A
Recruiting NCT03984864 - Preference, Exercise Therapy Adherence and Efficacy Low Back Pain N/A
Active, not recruiting NCT03427099 - The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis N/A