Methods: Twenty-two patients (11 males and 11 females; mean age 19.18 ± 2.00 years) having Angle's Class II division 1 malocclusion needing bilateral extractions of maxillary first bicuspids were recruited for this split-mouth randomized clinical trial. After the initial stage of alignment and leveling with contemporary edgewise MBT (McLaughlin-Bennett-Trevisi) prescription brackets (Ortho Organizers, Carlsbad, Calif) of 22 mil, followed by extractions of premolars bilaterally, 6 mm nickel-titanium spring was used to retract the canines separately by applying 150 g force on 0.019 × 0.025-in stainless steel working archwires. LIPUS (1.1 MHz frequency and 30 mW/cm2 intensity output) was applied for 20 minutes extraorally and reapplied after 3 weeks for 2 more successive visits over the root of maxillary canine on the experimental side whereas the other side was placebo. A numerical rating scale- (NRS-) based questionnaire was given to the patients on each visit to record their weekly pain experience. Impressions were also made at each visit before the application of LIPUS (T1, T2, and T3). Models were scanned with a CAD/CAM scanner (Planmeca, Helsinki, Finland). Mann-Whitney U test was applied for comparison of canine movement and pain intensity between both the groups.
Results: No significant difference in the rate of canine movement was found among the experimental (0.90 mm ± 0.33 mm) and placebo groups (0.81 mm ± 0.32 mm). There was no difference in pain reduction between experimental and placebo groups (p > 0.05).
Conclusion: Single-dose application of LIPUS at 3-week intervals is ineffective in stimulating the OTM and reducing associated treatment pain.
METHODS: This is an assessor-blinded quasi-experimental study comparing two approaches of physiotherapy, namely pulsed ultrasound-added physiotherapy and conventional physiotherapy. Total number of participants with TKA required for this study will be calculated based on the result of a pilot study. Participants will be alternately allocated into either pulsed ultrasound-added physiotherapy group (low-intensity pulsed ultrasound and conventional physiotherapy) or control group (conventional physiotherapy). Pulsed ultrasound-added physiotherapy group will receive low-intensity pulsed ultrasound starting at post-operative day 2 (4-5 times for the first-week after surgery and 2-3 times a week for a further 2 weeks). Both groups will receive conventional physiotherapy 4 to 5 times for the first-week after surgery and 2 to 3 times a week for a further 11 weeks. This procedure and process will be tested and established in a pilot study. Primary outcomes of interest are pain level, swelling, active range of knee motion, and quadriceps strength. The secondary outcomes are functional performance and quality of life.
DISCUSSION: This study will fill the gaps in knowledge relating the benefits of including low-intensity pulsed ultrasound into conventional physiotherapy for patients with TKA.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001226291.