Effects of positive and negative peer modelling versus neutral social interaction before spinal manipulative therapy in adults with chronic non-specific low back pain: protocol for a three-arm randomized controlled trial

Empathy and inflammatory biomarkers will be evaluated as exploratory outcomes.</p> <p>The trial will analyze whether the three simulated-patient conditions produce different short-term responses to identical SMT, without determining the effect of simulated-patient exposure compared with no exposure.</p> <p><a target="_blank" href="clinicaltrials.gov">www.clinicaltrials.gov</a> identifier is NCT07507604</p> <p>Long-lasting low back pain can make daily activities, movement, and wellbeing more difficult.

How well a treatment works may depend not only on the treatment itself but also on what people expect before receiving it. These expectations can be influenced by seeing or hearing about another person’s experience. In this study, adults with long-lasting low back pain will briefly meet a trained actor playing the role of another patient.

Depending on the study group, the actor will describe either a positive experience, a negative experience, or will have a brief neutral conversation unrelated to treatment. After this interaction, all participants will receive the same standardized spinal manipulation. The main outcome will be each participant’s current level of pain 60 min after treatment.

Pain will also be measured again after 24 h. The study will also assess stress, fear of movement, daily functioning, sensitivity to pressure, back movement, satisfaction with treatment, and whether participants felt that the treatment met their expectations. Blood samples will also be collected to explore possible changes in substances related to inflammation.

The study will help determine whether different messages and behaviors observed before treatment are associated with different short-term responses to the same spinal manipulation. However, because every participant will interact with the simulated patient before treatment, the study cannot determine whether observing another person is better or worse than receiving spinal manipulation without any such interaction.</p>