Brush head wear, subject-perceived and laboratory cleaning performance of two oscillating-rotating electric toothbrush heads over 3 months.

PURPOSE: To evaluate the progression of wear and the effect of wear on subject-perceived and laboratory cleaning efficacy of two oscillating-rotating electric brush heads, Oral-B Precision Clean (PC) and a store brand Easyflex (SB) brush head, after 4, 6, 8 and 13 weeks of use. METHODS: This research consisted of three phases: (1) Subject questionnaires--A crossover, single-blinded study was conducted among healthy adults who were regular users of Oral-B oscillating-rotating electric toothbrushes. Subjects were recruited from a general population and randomized based on age and gender into one of four cohorts reflecting the time period of use for each product: 4, 6, 8 or 13 weeks. After brushing with their first product (either PC or SB) for the designated period of time, subjects completed a questionnaire evaluating the brush head on 17 attributes related to perceived cleaning performance, brush head condition (i.e., durability) and brush head feel (i.e., gentleness). Subjects then used the second test product for the same period of time and completed the same questionnaire. (2) Wear index investigation--At the end of each time period, subjects' worn brush head pairs were evaluated by an independent, blinded investigator to determine the wear index score. (3) Robot testing--To analyze the laboratory cleaning efficacy of worn refills in the laboratory, a representative sample of 12 subject brush head pairs for each of the four cohorts were evaluated (96 brush heads in total). To analyze the laboratory cleaning efficacy for PC at Week 13 with SB at Week 4, a separate set of 20 subjects (40 brush heads in total) were evaluated. A robot was used to brush standard typodonts (Frasaco A3) covered with plaque substitute with the worn brush head for 2 minutes under standardized, controlled conditions simulating human brushing behavior. A 3D laser scan system was used to measure the area still covered with plaque substitute at different dental sites. RESULTS: Subject questionnaire--267 subjects completed study questionnaires. Statistically significant superior ratings (P < 0.05) were obtained with the PC brush head compared to the SB brush head for virtually all attributes at all four time periods (16/17 attributes for Weeks 4, 6 and 8 and 17/17 at Week 13). Highly significant advantages (P < 0.0001) were seen for 'overall rating', 'overall cleaning' and 'ready to replace brush head' attributes. Wear Index-- A total of 486 brush head samples (243 pairs) were analyzed for wear. At all four time periods, PC brush heads had a statistically significantly lower (P < 0.0005) mean wear index than SB brush heads. Robot Test--136 brush heads were analyzed using a laboratory (robot) test to investigate cleaning efficacy. Directionally higher laboratory cleaning for PC versus SB was observed for all dental sites (35/35) for all time periods. Comparing PC at Week 13 with SB at Week 4 showed statistically significant differences (P < 0.05) in favor of PC for the majority of dental sites and time periods (23/35).

Continuous low-level heat wrap therapy is effective for treating wrist pain.

OBJECTIVE: To evaluate the efficacy of continuous low-level heat wrap therapy for the treatment of various sources of wrist pain including strain and sprain (SS), tendinosis (T), osteoarthritis (OA), and carpal tunnel syndrome (CTS). DESIGN: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial. SETTING: Two community-based research facilities. PARTICIPANTS: Ninety-three patients (age range, 18-65 y) with wrist pain. INTERVENTION: Subjects with moderate or greater wrist pain were randomized and stratified to 1 of the following treatments: efficacy evaluation (heat wrap, n=39; oral placebo, n=42) or blinding (oral acetaminophen, n=6; unheated wrap, n=6). Data were recorded over 3 days of treatment and 2 days of follow-up. MAIN OUTCOME MEASURES: The primary comparison was between the heat wrap and the oral placebo group among SS/T/OA subjects for pain relief. Outcome measures included pain relief (0-5 scale), joint stiffness (101-point numeric rating scale), grip strength measured by dynamometry, and perceived pain and disability (Patient Rated Wrist Evaluation [PRWE]); subjects with CTS also completed the Symptom Severity Scale and Functional Status Scale. RESULTS: Heat wrap therapy showed significant benefits in day 1 to 3 mean pain relief (P=.045) and increased day 3 grip strength (P=.02) versus oral placebo for the SS/T/OA group. However, joint stiffness and PRWE results were comparable between the 2 treatments. For the CTS group, heat wraps provided greater day 1 to 3/hour 0 to 8 mean pain relief (P=.001), day 1 to 3 mean joint stiffness reduction (P=.004), increased day 3 grip strength (P=.003), reduced PRWE scores (P=.0015), reduced symptom severity (P=.001), and improved functional status (P=.04). In addition, the heat wrap showed significant extended benefits through follow-up (day 5) in the CTS group. CONCLUSIONS: Continuous low-level heat wrap therapy was efficacious for the treatment of common conditions causing wrist pain and impairment.

Continuous low-level heatwrap therapy for treating acute nonspecific low back pain.

OBJECTIVE: To evaluate the efficacy of 8 hours of continuous low-level heatwrap therapy for the treatment of acute nonspecific low back pain (LBP). DESIGN: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial. SETTING: Five community-based research facilities. PARTICIPANTS: Two-hundred nineteen subjects, aged 18 to 55 years, with acute nonspecific LBP. INTERVENTION: Subjects were stratified by baseline pain intensity and gender and randomized to one of the following groups: evaluation of efficacy (heatwrap, n=95; oral placebo, n=96) and blinding (oral ibuprofen, n=12; unheated back, wrap n=16). All treatments were administered for 3 consecutive days with 2 days of follow-up. MAIN OUTCOME MEASURES: Primary: day 1 mean pain relief (0- to 5-point verbal response scale). Secondary: muscle stiffness (101-point numeric rating scale), lateral trunk flexibility (fingertip-floor distance), and Roland-Morris Disability Questionnaire over 3 days of treatment and 2 days of follow-up. RESULTS: Heatwrap therapy was shown to provide significant therapeutic benefits when compared with placebo during both the treatment and follow-up period. On day 1, the heatwrap group had greater pain relief (1.76+/-.10 vs 1.05+/-.11, P <.001), less muscle stiffness (43.1+/-1.21 vs 47.6+/-1.21, P=.008), and increased flexibility (18.6+/-.44 cm vs 16.5+/-.45 cm, P=.001) compared with placebo. Disability was also reduced in the heatwrap group (5.3 vs 7.4, P=.0002). Adverse events were mild and infrequent. CONCLUSION: Continuous low-level heatwrap therapy was shown to be effective for the treatment of acute, nonspecific LBP.

Overnight use of continuous low-level heatwrap therapy for relief of low back pain.

OBJECTIVE: To evaluate of the efficacy and safety of 8 hours of continuous, low-level heatwrap therapy administered during sleep. DESIGN: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial. SETTING: Two community-based research facilities. PARTICIPANTS: Seventy-six patients, aged 18 to 55 years, with acute, nonspecific low back pain. INTERVENTIONS: Subjects were stratified by baseline pain intensity and gender and randomized to one of the following treatments: evaluation of efficacy (heatwrap, n=33; oral placebo, n=34) or blinding (unheated wrap, n=5; oral ibuprofen, n=4). All treatments were administered for 3 consecutive nights with 2 days of follow-up. MAIN OUTCOME MEASURES: Primary: morning pain relief (hour 0) on days 2 through 4 (0-5-point verbal response scale). Secondary: mean daytime pain relief score (days 2-4, hours 0-8), mean extended pain relief score (day 4, hour 0; day 5, hour 0), muscle stiffness, lateral trunk flexibility, and disability (Roland-Morris Disability Questionnaire). RESULTS: Heatwrap therapy was significantly better than placebo at hour 0 on days 2 through 4 for mean pain relief (P=.00005); at hours 0 through 8 on days 2 through 4 for pain relief (P<.001); at hour 0 on day 4 and at hour 0 on day 5 for mean pain relief (P<.001); on day 4 in reduction of morning muscle stiffness (P<.001); for increased lateral trunk flexibility on day 4 (P<.002); and for decreased low back disability on day 4 (P=.005). Adverse events were mild and infrequent. CONCLUSIONS: Overnight use of heatwrap therapy provided effective pain relief throughout the next day, reduced muscle stiffness and disability, and improved trunk flexibility. Positive effects were sustained more than 48 hours after treatments were completed.

Continuous low-level heat wrap therapy provides more efficacy than Ibuprofen and acetaminophen for acute low back pain.

STUDY DESIGN: A prospective, randomized, single (investigator) blind, comparative efficacy trial was conducted. OBJECTIVE: To compare the efficacy of continuous low-level heat wrap therapy (40 C, 8 hours/day) with that of ibuprofen (1200 mg/day) and acetaminophen (4000 mg/day) in subjects with acute nonspecific low back pain. SUMMARY OF BACKGROUND DATA: The efficacy of topical heat methods, as compared with oral analgesic treatment of low back pain, has not been established. METHODS: Subjects (n = 371) were randomly assigned to heat wrap (n = 113), acetaminophen (n = 113), or ibuprofen (n = 106) for efficacy evaluation, or to oral placebo (n = 20) or unheated back wrap (n = 19) for blinding. Outcome measures included pain relief, muscle stiffness, lateral trunk flexibility, and disability. Efficacy was measured over two treatment days and two follow-up days. RESULTS: Day 1 pain relief for the heat wrap (mean, 2) was higher than for ibuprofen (mean, 1.51; P = 0.0007) or acetaminophen (mean, 1.32; P = 0.0001). Extended mean pain relief (Days 3 to 4) for the heat wrap (mean, 2.61) also was higher than for ibuprofen (mean, 1.68; P = 0.0001) or acetaminophen (mean, 1.95; P = 0.0009). Lateral trunk flexibility was improved with the heat wrap (mean change, 4.28 cm) during treatment (P