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.

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.

Effects of spinal stabilization exercise with real-time ultrasound imaging biofeedback in individuals with chronic nonspecific low back pain: a pilot study.

The use of real-time ultrasound imaging (RUSI) as biofeedback to enhance the performance of spinal stabilization exercise and recovery from low back pain has been a recent trend in musculoskeletal rehabilitation. The aim of this pilot study was to evaluate whether it would be feasible to conduct a randomized controlled trial investigating the effects of spinal stabilization exercise with RUSI biofeedback in individuals with chronic nonspecific low back pain. This was a single-group pretest-posttest quasi-experimental study. Ten consecutive patients with chronic nonspecific low back pain met the study criteria. They received spinal stabilization exercise with the RUSI biofeedback focusing on lumbar multifidus muscle activation. The intervention was provided twice weekly for 6 weeks. Outcome measures were lumbar multifidus muscle cross-sectional area, pain, disability and quality of life assessed at baseline and after intervention. A paired t-test was applied and effect size (Cohen d) was computed. The recruitment and retention rates were 75% and 83% respectively. No adverse events were reported during the study. Compared with the baseline, the participants demonstrated statistically significant improvement in lumbar multifidus muscle cross-sectional area (P<0.05, d=1.03), pain (P<0.001, d=2.56) and disability (P<0.05, d=1.43) with large effect size after the intervention. However, no statistically significant differences were observed for physical and mental health (P>0.05) after the intervention. It was concluded that spinal stabilization exercise with RUSI biofeedback is effective in improving lumbar multifidus muscle cross-sectional area, pain and disability in individuals with chronic nonspecific low back pain. The results demonstrated the feasibility of conducting a future, larger-scale powered randomized controlled trial to confirm these preliminary findings.