Context • Low-back pain (LBP) is a prevalent and potentially crippling condition for which treatment is often unsatisfactory from the perspectives of physicians, patients, and payers. The application of the fascial distortion model (FDM), an integrated concept for the diagnosis and manipulative treatment of musculoskeletal disorders, is conceptually promising for LBP but has not been investigated systematically. Objective • The study intended to provide proof of concept to establish the noninferiority of the FDM treatment as opposed to the therapy recommended by the German National Disease Management Guideline (NDMG) for acute LBP. Design • The study was a prospective, nonrandomized, controlled, parallel-group trial. Setting • The study took place in a private practice for surgery and orthopedics. Participants • Seventy-seven outpatients with acute LBP with an average age of 42.6 ± 13.5 y, 50.6% of whom were male, took part in the study. Intervention • Participants in the intervention group (FDM group) received osteopathic manipulative treatments according to the FDM, whereas the control group (NDMG group) received an active control treatment following the NDMG. Outcome Measures • Comparing the FDM group (n = 39) and the NDMG group (n = 38), the study measured pain (visual analog scale, patient diary), functional (FFbH-R) and self-reported vocational status, and use of medication (patient diary) at baseline and after 1, 4 and 12 wk of treatment. Results • The study found marked improvements of the symptoms in both groups, with a faster onset of efficacy and significantly less medication under the FDM treatment. Conclusions • FDM appears to be effective with regard to pain relief and functional improvement for LBP.