Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation.

Background: Spinal manipulation (SM) is used commonly for treating low back pain (LBP). Spinal stiffness is routinely assessed by clinicians performing SM. Flexion-relaxation ratio (FRR) was shown to distinguish between LBP and healthy populations. The primary objective of this study was to examine the association of these two physiological variables with patient-reported pain intensity and disability in adults with chronic LBP (>12 weeks) receiving SM.

Methods: A single-arm trial provided 12 sessions of side-lying thrust SM in the lumbosacral region over 6 weeks. Inclusion criteria included 21-65 years old, Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6 and numerical pain rating score ≥ 2. Spinal stiffness and FRR were assessed pre-treatment at baseline, after 2 weeks and after 6 weeks of treatment. Lumbar spine global stiffness (GS) were calculated from the force-displacement curves obtained using i) hand palpation, ii) a hand-held device, and iii) an automated indenter device. Lumbar FRR was assessed during trunk flexion-extension using surface electromyography. The primary outcomes were RMDQ and pain intensity measured by visual analog scale (VAS). Mixed-effects regression models were used to analyze the data.

Results: The mean age of the 82 participants was 45 years; 48% were female; and 84% reported LBP >1 year. The mean (standard deviation) baseline pain intensity and RMDQ were 46.1 (18.1) and 9.5 (4.3), respectively. The mean reduction (95% confidence interval) after 6 weeks in pain intensity and RMDQ were 20.1 mm (14.1 to 26.1) and 4.8 (3.7 to 5.8). There was a small change over time in the palpatory GS but not in the hand-held or automated GS, nor in FRR. The addition of each physiologic variable did not affect the model-estimated changes in VAS or RMDQ over time. There was no association seen between physiological variables and LBP intensity. Higher levels of hand-held GS at L3 and automated GS were significantly associated with higher levels of RMDQ (p = 0.02 and 0.03, respectively) and lower levels of flexion and extension FRR were significantly associated with higher levels of RMDQ (p = 0.02 and 0.008, respectively) across the 3 assessment time points.

Conclusions: Improvement in pain and disability observed in study participants with chronic LBP was not associated with the measured GS or FRR.

Trial Registration: NCT01670292 on clinicaltrials.gov, August 2, 2012.