Dataset Information

Effectiveness of lumbar stabilization exercise with real-time ultrasound imaging biofeedback on lumbar multifidus muscle cross-sectional area in individuals with non-specific chronic low back pain: a study protocol for a randomized controlled trial.

ABSTRACT:

Background

Structural impairment of the lumbar multifidus muscle, such as reduced cross-sectional area, is evident among individuals with chronic low back pain. Real-time ultrasound imaging (RUSI) biofeedback has been reported to improve preferential activation of as well as retention in the ability to activate the lumbar multifidus muscle during lumbar stabilization exercises (LSE). However, evidence of the effectiveness of this treatment approach in individuals with non-specific chronic low back pain (NCLBP) is still limited. The purpose of this study is, therefore, to determine the effectiveness of LSE with RUSI biofeedback on lumbar multifidus muscle cross-sectional area in individuals with NCLBP.

Methods/design

This study is a prospective, single-center, assessor-blind, three-arm, parallel randomized controlled trial to be conducted at National Orthopedic Hospital, Kano State, Nigeria. Ninety individuals with NCLBP will be randomized in a 1:1:1: ratio to receive LSE, LSE with RUSI biofeedback, or minimal intervention. All participants will receive treatment twice weekly for 8 weeks. The primary outcome will be the lumbar multifidus muscle cross-sectional area. The secondary outcomes will include pain (Numerical Pain Rating Scale), functional disability (Roland-Morris Disability Questionnaire), and quality of life (12-Item Short-Form Health Survey). All outcomes will be assessed at baseline, 8 weeks post-intervention, and 3 months follow-up.

Discussion

To our knowledge, this study will be the first powered randomized controlled trial to compare the effectiveness of LSE training with and without RUSI biofeedback in individuals with NCLBP. The outcome of the study may provide evidence for the effectiveness of LSE with RUSI biofeedback on enhancing the recovery of the lumbar multifidus muscle in individuals with NCLBP.

Trial registration

Pan African Clinical Trials Registry ( PACTR201801002980602) . Registered on January 16, 2018.

SUBMITTER: Sarafadeen R

PROVIDER: S-EPMC8734067 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionLumbar multifidus muscle (LMM) dysfunction is thought to be related to pain and/or disability in people with chronic low back pain (CLBP). Although psychosocial factors play a major role in pain/disability, they are seldom considered as confounders in analyzing the association between LMM and CLBP.ObjectivesThis study aimed to determine: (1) differences in psychological factors, insomnia, and LMM characteristics between people with and without CLBP; (2) associations between psychological factors, insomnia, or LMM characteristics and low back pain (LBP) intensity or LBP-related disability in people with CLBP; and (3) whether LMM characteristics are related to LBP symptoms in people with CLBP after considering confounders.MethodsSeventy-eight volunteers with CLBP and 73 without CLBP provided sociodemographic information, filled the 11-point numeric pain rating scale and Roland-Morris disability questionnaire (RMDQ). They completed the Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), Fear Avoidance Belief Questionnaire (FAB), and Insomnia Severity Index Scale (ISI). Resting and contracted thickness of LMM at L4-S1 levels were measured from brightness-mode ultrasound images. Percent thickness changes of LMM at L4-S1 levels during contraction were calculated. Resting LMM stiffness at L4-S1 was measured by shear wave elastography. Associations among LMM, psychosocial or insomnia parameters and clinical outcomes were analyzed by univariate and multivariate analyses.ResultsPeople with CLBP demonstrated significantly higher LBP-intensity, RMDQ, HADS, FAB, PCS, and ISI scores than asymptomatic controls (p < 0.05). The former also had significantly smaller percent thickness changes of LMM at L4/L5 during contraction. LBP-intensity was positively related to scores of PCS-total, PCS-helplessness, FAB-total, FAB-work, and ISI in people with CLBP (p < 0.05). RMDQ scores were positively associated with the scores of HADS-total, HADS-depression, PCS-total, FAB-total, FAB-physical activity, PCS-helplessness, and ISI in people with CLBP (p < 0.05). FAB-work and ISI scores together explained 24% of LBP-intensity. FAB-total scores alone explained 34% of variance of LBP-related disability in people with CLBP.ConclusionMore fear-avoidance belief or insomnia is related to greater LBP-intensity and/or LBP-related disability in people with CLBP. Although people with CLBP were thought to have aberrant LMM morphometry/function, no LMM characteristics were related to LBP-intensity or LBP-related disability after considering other confounders.