Effectiveness of Kalevala Manual Therapy, Health Coaching, and Physiotherapy for Chronic Low Back Pain: A Randomized Controlled Trial (The INTEGRA Trial)
Year: 2026
Type: preprint
Study designs: Randomized Controlled Trial, Clinical 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.
Source: medRxiv
Language: English
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7223247674