Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial

Purpose: Low-intensity continuous ultrasound (LICUS) is an emerging high-dosimetry ultrasound-based therapy for accelerated tissue healing and the treatment of myofascial pain. In this study, LICUS treatment is clinically evaluated for chronic upper neck and shoulder pain in a randomized, multi-site, double-blind, placebo-controlled study. Patients and Methods: CONSORT guidelines were followed in conducting and reporting the clinical trial. Thirty-three participants with upper trapezius myofascial pain were randomized for treatment with active (n=25) or placebo (n=8) devices. Investigators and subjects were blinded to treatment groups. Participants self-reported pain daily, rating from 0– 10 on the numeric rating scale. If pain rating was more significant than or equal to 3, the LICUS (3MHz, 0.132W/cm 2, 1.3W, 4 hours) was self-applied for total energy dosimetry of 18,720 Joules per treatment. During the 4-week study, daily pain rating was recorded. If LICUS treatment was delivered, pain before, during, and after treatment were recorded as well as the global rate of change (GROC). Independent t-tests were used to assess change from baseline and differences between treatment groups. ClinicalTrials.gov: NCT02135094. Results: There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures. Participants treated with active therapy observed a significant mean pain reduction from baseline of 2.61 points for active (p\u3c 0.001), compared to 1.58 points decrease from baseline for placebo (p=0.087), resulting in a 1.03 points significant decrease in the active group over placebo (p=0.003). The total GROC was significantly higher in the active group at 2.84 points compared to the placebo group at 0.46 points (p\u3c 0.001). Conclusion: Low-intensity continuous ultrasound treatment significantly reduced pain in patients with upper trapezius myofascial pain of the neck and shoulder. LICUS treatment showed a clinically meaningful improvement in the GROC scores for patients. The results from this clinical trial indicate that the LICUS treatment of 18,720 Joules can effectively be used to treat clinical pain related to upper trapezius myofascial pain. Further research could investigate varying dosimetry to improve efficacy and/or reduce the dose

Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study

Background: Sustained Acoustic Medicine (SAM) is an emerging, non-invasive, non-narcotic, home-use ultrasound therapy for the daily treatment of joint pain. The aim of this multi-site clinical study was to examine the efficacy of long-duration continuous ultrasound combined with a 1% diclofenac ultrasound gel patch in treating pain and improving function in patients with knee osteoarthritis. Methods: The Consolidated Standards of Reporting Trials (CONSORT) were followed. Thirty-two (32) patients (18-males, 14-females) 54 years of average age with moderate to severe knee pain and radiographically confirmed knee osteoarthritis (Kellgren-Lawrence (KL) grade II/III) were enrolled for treatment with the SAM device and diclofenac patch applied daily to the treated knee. SAM ultrasound (3 MHz, 0.132 W/cm2, 1.3 W) and 6 grams of 1% diclofenac were applied with a wearable device for 4 hours daily for 1 week, delivering 18,720 Joules of ultrasound energy per treatment. The primary outcome was the daily change in pain intensity using a numeric rating scale (NRS 0-10), which was assessed prior to intervention (baseline, day 1), before and after each daily treatment, and after 1 week of daily treatment (day 7). Rapid responders were classified as those patients exhibiting greater than a 1-point reduction in pain following the first treatment. Change in Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC) score from baseline to day 7 was the secondary functional outcome measure. Additionally, a series of daily usability and user experience questions related to devising ease of use, functionality, safety, and effectiveness, were collected. Data were analyzed using t-tests and repeated measure ANOVAs. Results: The study had a 94% retention rate, and there were no adverse events or study-related complaints across 224 unique treatment sessions. Rapid responders included 75% of the study population. Patients exhibited a significant mean NRS pain reduction over the 7-day study of 2.06-points (50%) for all subjects (n=32, p Conclusion: Sustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain. The clinical findings suggest that this treatment approach may be used as a conservative, non-invasive treatment option for patients with knee osteoarthritis. Additional research is warranted on non-weight bearing joints of the musculoskeletal system as well as different topical drugs that could benefit from improved localized delivery

Fracture dislocations of the elbow in athletes

Contains fulltext : 151523.pdf (publisher's version ) (Open Access)8 p

Reliability and Validity of the Knee Injury and Osteoarthritis Outcome Score in Patients Undergoing Unicompartmental Knee Arthroplasty

BACKGROUND: The Knee Injury and Osteoarthritis Outcome Score (KOOS) was developed to document outcomes from knee injury, including the impact of osteoarthritis on knee function. The purpose of this study is to determine the reliability and validity of the KOOS subscales for evaluating outcomes following unicompartmental knee arthroplasty (UKA). METHODS: KOOS Pain, Activities of Daily Living (ADL), Sport, Symptoms, and Quality of Life (QoL) scores collected from 172 patients who underwent UKA were used in the analysis. KOOS subscales were tested for reliability and validity of scores through a Rasch model analysis. RESULTS: KOOS Sport, KOOS ADL, and KOOS QoL had good evidence of reliability with acceptable person reliability, person separation, and item reliability. For overall scale functioning, KOOS Pain, Symptoms, and ADL all had 1 question that did not have an acceptable value for infit or outfit mean square value. Questions in KOOS Sport and QoL all had acceptable values. There was a positive, linear relationship between the Short-Form 12 Physical Component Summary and the KOOS subscales which indicated good evidence of convergent validity. These associations were also seen when the cohort was separated in medial and lateral UKA. CONCLUSION: Two of the 5 KOOS subscales (KOOS Sport and KOOS QoL) were considered adequate in measuring outcomes, as well as reliability. The KOOS ADL had borderline values; however, it had adequate infit and outfit values. The KOOS Pain and Symptom score performed poorly in this analysis. For documenting outcomes following UKA, this study supports the use of KOOS ADL, Sport, and QoL