Long Duration Sonophoresis of Diclofenac to Augment Rehabilitation of Common Musculoskeletal Injuries

Background: The use of long duration sonophoresis (LDS) for musculoskeletal injuries is a new and emerging treatment option for patients undergoing rehabilitation. The treatment is non-invasive, provides multi-hour mechanical stimulus expediating tissue regeneration and deep tissue heat along with local application of therapeutic compound for improved pain relief. The objective of this prospective case study was to evaluate real-world application of diclofenac LDS as an add-on intervention for patients non-responsive to physical therapy alone. Methods: Patient who failed to respond to at least 4 weeks of physical therapy were treated with the addition of 2.5% diclofenac LDS daily for 4 weeks. The numerical rating scale, global health improvement score, functional improvement, and treatment satisfaction index were measured to assess pain reduction and quality of life improvement from treatment. Patient outcome data was organized by injury type and patient age groups, and statistically analyzed with ANOVA to assess treatment differences within and between groups. The study was registered on clinicaltrails.gov NCT05254470. Result: The study included (n=135) musculoskeletal injury LDS treatments with no adverse events. Patients reported a mean pain reduction from baseline of 4.44 points (p\u3c0.0001) and a 4.85point health improvement score after 4-week of daily sonophoresis treatment. There were no age-related differences in pain reduction, and 97.8% of patients in the study reported functional improvement with the addition of LDS treatment. Significant pain relief was observed in injuries related to tendinopathy, sprain, strain, contusion, bone fracture, and post-surgical recovery. Conclusion: The use of LDS significantly reduced pain and improved musculoskeletal function and quality of life for patients. Clinical findings suggest that LDS with 2.5% diclofenac is a viable therapeutic option for practitioners and should be further investigated

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

Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy

Objectives: The effectiveness of sustained acoustic medicine to alleviate pain and improve function in subjects with elbow or Achilles tendinopathy was evaluated through a level IV case series study. Subjects were trained to self-apply the wearable, long-duration, low-intensity ultrasonic device on their affected body part at home for 4 hours a day, at least 5 times per week over 6 weeks. Twenty-five subjects with clinician-diagnosed tendinopathy of the elbow (medial or lateral epicondyle) or Achilles tendon were enrolled. Methods: Pain measurements were recorded before, during, and after daily intervention using an 11-point numeric rating scale (NRS). Function of the injured limb was assessed biweekly using dynamometry. Repeated measures ANOVAs and paired-samples t-tests were used to examine the effect of treatment over time. Results: Among subjects with elbow tendinopathy (n = 20), a 3.94 ± 2.15 point reduction in pain (p = 0.002) was observed over the 6-week study and a 2.83 ± 5.52 kg improvement in grip strength (p = 0.04) was observed over the first two weeks. In addition, a significant reduction in pain was observed within the 4-h treatment sessions (p < 0.001). Among 5 subjects with Achilles tendinopathy, a reduction in pain and improvement in strength was also observed. Conclusions: Daily multi-hour ultrasonic therapy was associated with improved pain and increased function in subjects with chronic tendon injuries. This trial showed the safety and feasibility of self-administration of sustained acoustic medicine, and suggests that this therapy may be clinically beneficial in the treatment of tendinopathies of the elbow and Achilles tendon. A randomized controlled trial appears warranted to more definitively investigate the therapeutic potential of this treatment modality. Registered at www.ClinicalTrials.gov , NCT0246630