Sustained acoustic medicine treatment of discogenic chronic low back pain: A randomized, multisite, double-blind, placebo-controlled trial.

BACKGROUND: Sustained acoustic medicine (SAM) is a noninvasive long-term treatment that provides essential mechanical and thermal stimulus to accelerate soft tissue healing, alleviate pain, and improve physical activity. SAM increases localized deep tissue temperature, blood flow, cellular proliferation, migration, and nutrition exchange, resulting in reduced inflammation and an increased rate of tissue regeneration. OBJECTIVE: To assess the efficacy of SAM treatment of discogenic back pain in the lower spinal column to reduce pain, improve quality of life, and lower pharmacotherapy use. METHODS: Sixty-five subjects with chronic low back pain were randomly assigned to SAM (N= 33) or placebo (N= 32) groups. Subjects self-applied SAM device bilaterality on the lower lumbar region for 4 hours daily for 8 weeks and completed daily pain diaries before, during, and after treatment. Subjects recorded pain reduction using a numeric rating scale (NRS), medication use, and physical activity using the Global Rating of Change (GROC) and Oswestry Disability Index (ODI). RESULTS: SAM treatment significantly reduced chronic lower back pain from baseline relative to placebo treatment (p< 0.0001). SAM treated subjects reported significantly lower back pain at 4 weeks, with the highest pain reduction (-2.58 points NRS, p< 0.0001) reported at 8 weeks. Similar trends were observed in improved physical activity (3.48 GROC, p< 0.0001, 69-88% ODI, p< 0.0001) and 22.5% (15.2 morphine milligram equivalent) reduction in the use of opioid medication from baseline to 8 weeks. CONCLUSION: Daily, home-use SAM treatment significantly improves the clinical symptoms of chronic lower back pain, improves physical mobility, and reduces daily medication use. SAM treatment is well-tolerated by patients and may be considered a safe, non-invasive treatment option for chronic discogenic, lower back pain.

Evaluation of Sustained Acoustic Medicine for Treating Musculoskeletal Injuries in Military and Sports Medicine.

Background: Musculoskeletal injuries are common in collegiate, professional, and military personnel and require expedited recovery to reduce lost work time. Sustained acoustic medicine (SAM) provides continuous long-duration ultrasound at 3MHz and 132mW/cm2. The treatment is frequently prescribed to treat acute and chronic soft tissue injuries and reduce pain. The objective of this study was to evaluate the efficacy of SAM treatment for musculoskeletal injuries and accelerated recovery. Methods: An 18-question electronic survey and panel discussion were conducted on Athletic Trainers (ATs) using SAM treatment in professional, collegiate, and military sports medicine. The survey included both qualitative and quantitative questions. In addition, a panel discussion discussed SAM effectiveness with expert ATs. Power calculation of sampling and statistical evaluation of data was utilized to generalize the results. Results: Survey respondents (n=97) and panelists (n=142) included ATs from all National Athletic Trainers Association districts. SAM was primarily used for musculoskeletal injuries (83.9%, p<0.001) with a focus on healing tendons and ligaments (87.3%, p<0.001). SAM treatment was also used on joints (44.8%), large muscle groups (43.7%), and bone (41.4%). SAM provided clinical improvement in under 2 weeks (68.9%, p<0.001) and a 50% reduction in pain medication (63%, p<0.001). In addition, patients were highly receptive to treatment (87.3%, p<0.001), and ATs had a high level of confidence for improved function and returned to work after 30-days of SAM use (81.2%, p<0.001). Conclusion: SAM is an effective, safe, easy-to-use, noninvasive, comfortable, and versatile therapeutic for healing musculoskeletal injuries.

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/cm2, 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<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<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<0.001) and 2.96-points (70%) for rapid responders (n=24, p<0.001). The WOMAC functional score significantly improved by 351 points for all subjects (n=32, p<0.001), and 510 points for rapid responders (n=24, p<0.001). Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms. 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.Clinical Trial Registry Number: (NCT04391842).

Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study.

BACKGROUND: Wearable long-duration low-intensity ultrasound is an emerging non-invasive and non-narcotic therapy for the daily treatment of musculoskeletal pain. The aim of this randomized, double-blind, placebo-controlled study was to examine whether long-duration low-intensity ultrasound was effective in treating pain and improving function in patients with knee osteoarthritis. METHODS: Ninety patients with moderate to severe knee pain and radiographically confirmed knee osteoarthritis (Kellgren-Lawrence grade I/II) were randomized for treatment with active (n = 55) or placebo (n = 35) devices applied daily to the treated knee. Investigators and subjects were blinded to treatment groups. Ultrasound (3 MHz, 0.132 W/cm2, 1.3 W) was applied with a wearable device for 4 h daily for 6 weeks, delivering 18,720 J per treatment. The primary outcome was change in pain intensity (numeric rating scale) assessed prior to intervention (baseline) and after 6 weeks. Secondary outcomes of functional change were measured at baseline and after 6 weeks using the Western Ontario McMaster Osteoarthritis Questionnaire (n = 84), along with range of motion (flexion, extension) and isometric muscle strength (flexion, extension and rotation) tests on the injured knee in a small pilot subset (n = 17). RESULTS: The study had a 93% retention rate, and there were no significant differences between the groups regarding demographic variables or baseline outcome measures. Patients treated with active therapy observed a significant mean NRS pain reduction over the 6-week study of 1.96 points for active (p < 0.0001), compared with a 0.85 points reduction for placebo (p = 0.13). The functional score was also significantly improved by 505 points for the active group over the 311-point improvement for placebo group compared to baseline (p = 0.02). In the pilot subset evaluated, rotational strength increased from baseline to 6 weeks (3.2 N, p = 0.03); however, no other measures were significant. CONCLUSIONS: Long-duration low-intensity ultrasound significantly reduced pain and improved joint function in patients with moderate to severe osteoarthritis knee pain. The clinical findings suggest that ultrasound may be used as a conservative non-pharmaceutical and 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 extended treatment time frames and follow-up. TRIAL REGISTRATION: NCT02083861, registered 11 March 2014, https://clinicaltrials.gov/ct2/show/results/NCT02083861.

Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis.

Osteoarthritis is one of the leading causes of disability in the aging population. Long duration, low intensity therapeutic ultrasound has had promising impact in animal models to slow the progression of the disease and provide joint relief. Two pilot studies were conducted using a novel, wearable platform for delivering ultrasound to evaluate the potential clinical benefits of ultrasound therapy on knee osteoarthritis. There was a pain reduction effect from using ultrasound, as high as fifty two percent in one study. As well, initial data demonstrates that mobility may be increased for patients experiencing mild to moderate arthritis of the knee.

Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain.

Ultrasound therapy for pain and healing is a versatile treatment modality for musculoskeletal conditions that is used daily in rehabilitation clinics around the world. Our group designed and constructed a wearable, battery-operated, low-intensity therapeutic ultrasound (LITUS) device that patients could self-apply and operate during daily activity for up to 6 h. Thirty patients with chronic trapezius myofascial pain evaluated the LITUS system in a double-blind, placebo-controlled, 10-d study under institutional review board approval. While continuing their prescribed medication regimen, patients with the active device reported on average 1.94× reduction in pain and 1.58× improvement in health relative to placebo devices after 1 h of treatment. Both of these results were statistically significant (p < 0.05) for the first 2 d of the study. Male patients reported the majority of benefit, and there is a sex-treatment confound in the sample. The study indicates that wearable, long-duration LITUS technology improves mobile access to drug-free pain relief.

Burkitt transformation of mantle cell lymphoma.

The associated poor prognosis and potentially aggressive behavior of mantle cell lymphoma and its blastoid variants make differentiation from other non-Hodgkin B-cell lymphomas especially important. We present a case of mantle cell lymphoma with a marked leukemic component, which demonstrated both a typical nodular mantle cell pattern and Burkitt lymphoma within a single lymph node removed at the time of splenectomy. The presence of CD5, CD10, and Bcl-1 co-expression by immunohistochemistry and detectable t(11;14) and cMYC gene rearrangement by FISH analyses in the Burkitt region support a transformation of mantle cell lymphoma over a concomitant malignancy. A limited number of mantle cell lymphomas demonstrating dual t(11;14) and chromosome 8q24 cMYC gene rearrangements have been previously reported in the literature. They demonstrate an extremely aggressive course with a very poor prognosis. Although the accelerated terminal phase of this patient's clinical course mirrors these previous published cases; none have described the combined morphologic and immunophenotypic features of Burkitt lymphoma reported here. This case provides further support for the aggressive nature of these lymphomas and demonstrates the utility of flow cytometry, immunohistochemistry, and cytogenetic techniques in avoiding potential errors in their diagnosis, prognosis, and treatment.