Effectiveness of Kalevala Manual Therapy, Health Coaching, and Physiotherapy for Chronic Low Back Pain: A Randomized Controlled Trial (The INTEGRA Trial)

Abstract Background and aim: Low back pain is the leading cause of years lived with disability (YLDs) globally. While physiotherapy (PT) is recommended as a first-line treatment, evidence regarding Kalevala Manual Therapy (KMT) remains limited. This study compared the effects of physiotherapy, KMT, and KMT combined with health coaching (KMT+HC) on pain, disability, and psychosocial outcomes in individuals with CLBP. Experimental procedure: In this single-center, three-arm, parallel-group trial, 81 adults with non-specific CLBP (symptoms ≥12 weeks, STarT Back score >3) were randomized (1:1:1) to receive PT (n=27), KMT (n=27), or KMT+HC (n=27) over an 8-week intervention period. Primary outcomes were functional disability (Oswestry Disability Index, ODI) and pain intensity (Numeric Rating Scale, NRS). Secondary outcomes included work- and physical activity-related fear-avoidance beliefs (FABQ-W, FABQ-PA), depressive symptoms (BDI), quality of life (RAND-36), and patient-specific functional status (PSFS). Longitudinal changes were analyzed using linear mixed models. Results: Statistically significant and generally clinically meaningful improvements over time were observed across the intervention groups for both ODI and NRS (both p < 0.001), with no significant between-group differences in the primary outcomes. No significant between-group differences were identified for the primary outcomes. A significant group-by-time interaction was observed for work-related fear-avoidance beliefs (FABQ-W; p=0.005). Post hoc analyses revealed that KMT+HC achieved a significantly greater reduction in FABQ-W scores than PT (p=0.002), with only the KMT+HC group exceeding the established minimal clinically important difference (MCID) threshold. Overall treatment satisfaction was high, with a mean score of at least 6.2 out of 7 and 100% protocol adherence were observed across all arms without any reported adverse events. Conclusion: KMT and KMT combined with health coaching produced improvements in pain and functional disability comparable to guideline-based physiotherapy. Furthermore, the addition of structured health coaching to KMT significantly reduced work-related fear-avoidance beliefs, demonstrating the value of integrating behavioral support into manual therapy for comprehensive CLBP rehabilitation. Keywords: chronic low back pain; Kalevala Manual Therapy; physiotherapy; health coaching; fear-avoidance beliefs; randomized controlled trial.