Abstract
Background
Spinal manipulative therapy (SMT) includes biomechanical parameters that vary between clinicians, but for which the influence on the therapy clinical effects is unknown. This parallel-randomized controlled trial aimed to investigate the effect of SMT biomechanical parameters on the outcomes of participants with chronic thoracic pain (CTP) following three treatment sessions (follow-up at one week).
Methods
Adults reporting CTP (pain within the evaluated region [T6 to T8] for ≥3 months) were asked to participate in a four-session trial. At the first session, participants were randomly assigned to one of three experimental groups (different SMT doses) or the control group (no SMT). During the first three sessions, one SMT was executed at T7 for the experimental groups, while a 5-min rest was provided to the control group. SMT were delivered through an apparatus using a servo-controlled linear actuator motor and doses consisted of peak forces, impulse durations, and rates of force application set at 135 N, 125 ms and 920 N/s (group 1), at 250 N, 125 ms and 1840 N/s (group 2), and at 250 N, 250 ms, 920 N/s (group 3). Disability and pain intensity were evaluated at each session (primary outcomes). Spinal stiffness was assessed before-and-after each SMT/rest and at follow-up. Tenderness and muscle activity were evaluated during each spinal stiffness trial. Improvement was evaluated at follow-up. Differences in outcomes between groups and sessions were evaluated as well as factors associated with clinical improvement.
Results
Eighty-one participants were recruited and 17, 20, 20 participants of the three experimental groups and 18 of the control group completed the protocol. In exception of higher pain intensity at baseline in the control group, no between-group differences were found for any of the outcomes. A decrease in pain intensity, disability, spinal stiffness, and tenderness during spinal stiffness were observed (p-values< 0.05). At follow-up, 24% of participants were classified as 'improved'. Predictors of improvement were a greater decrease in pain intensity and in tenderness (p-values< 0.05).
Conclusions
In an experimental setting, the delivery of a SMT does not lead to significantly different outcomes in participants with CTP than a control condition (spinal stiffness assessment). Studies are still required to explore the mechanisms underlying SMT effects.
Trial registration
ClinicalTrials.gov NCT03063177, registered 24 February 2017).
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