Abstract
Introduction
This pilot trial reports the findings of Randomized controlled trial (RCT) investigating the initial estimates of the effects of spinal manipulations on systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation (SpO2) in patients suffering from functional scoliosis as well as determine the feasibility and acceptability of spinal manipulation in the management of Functional scoliosis for full trial and to obtain pilot data to perform sample size calculation for full trial.
Material and methods
A Single –blinded trial was done in accordance with CONSORT guidelines 2010. Thirty patients of functional scoliosis with ‘Intention to treat Analysis’ were recruited. The participants were randomly allocated into experimental (n=15) and Control group (n=15). Experimental group received spinal manipulations with Grade 5 high velocity thrust and Schroth exercise whereas Control group received only Schroth exercise. Feasibility and acceptability were assessed by number of participants completing the baseline and post-intervention data of treatment process.
Results
Experimental group showed a statistically significant improvement in SBP (MD=10.73; 95% CI= 4.63, 7.49), DBP (MD=10.13; 95% CI= 5.80, 8.06) and SpO2 (MD=-7.2; 95% CI= -5.55, -3.51) as compared to control group in terms of SBP (MD=4.66; 95% CI= 3.63, 5.50), DBP (MD=3.2; 95% CI= 3.20, 4.01) and SpO2 (MD=-2.7; 95% CI= -3.55, -2.50). Results suggested that outcome measures were feasible and acceptable.
Conclusions
This pilot study is feasible and acceptable to do a fully powered randomised controlled trial. This study also concluded that spinal manipulations combined with Schroth exercises may significantly reduce the blood pressures and improve the oxygen saturation levels.