Dataset Information

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

ABSTRACT:

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).

SUBMITTER: Madzia A

PROVIDER: S-EPMC7784557 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

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

Madzia Alex A Agrawal Chirag C Jarit Paddy P Petterson Stephanie S Plancher Kevin K Ortiz Ralph R

The open orthopaedics journal 20201218

<h4>Background</h4>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.<h4>Methods</h4>The Consolidated Standards of Reporting Trials (CONSORT) were followed. Thirty-two ...[more]

PMID: 33408796

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Project description:BackgroundLow-intensity Continuous Ultrasound (LICUS) therapy heals soft tissue injuries. It alleviates acute and chronic musculoskeletal pain by activating multiple healing processes through its diathermic and mechanotransducive properties. Diclofenac has been FDA-approved as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is an analgesic and anti-inflammatory drug available in oral and topical forms. Adding 2.5% diclofenac sodium to ultrasound coupling gel can be used to deliver LICUS in addition to the analgesic effects of diclofenac sodium without altering the diathermic and acoustic effects of the ultrasound penetration with no undesired adverse effects.ObjectiveTo determine the effects of adding 2.5% diclofenac sodium to standard aqueous ultrasound gel on the ultrasound coupling and diathermic properties of a long duration Sustained Acoustic Medicine (SAM) treatment.MethodsIn a two-phase study, first, the acoustic and diathermic changes were determined in bovine tissue during 4-hour-long SAM stimulation at 1 cm, 2 cm, and 5 cm with aqueous and 2.5% diclofenac ultrasound coupling patch. Then, in the second phase, the heating profiles were recorded with and without 2.5% diclofenac gel in 54 healthy adult subjects at the forearm and calf during the SAM treatment.ResultThe addition of 2.5% diclofenac sodium significantly increased coupling gel density, acoustic impedance, and signal propagation (p<0.0001) with little or no effect on the diathermic profiles at 1 cm, 2 cm, and 5 cm depth. The coupling gel with 2.5% diclofenac sodium sustained the therapeutic ultrasound intensity longer than the aqueous coupling gel (5.5 cm relative to 4.5, p<0.0009). No significant diathermic difference was recorded on the calf and forearm skin with a 2.5% diclofenac ultrasound gel coupling patch.ConclusionAdding 2.5% diclofenac sodium to ultrasound gel increases acoustic impedance, improves ultrasound signal coupling into deep tissue, and provides longer sustained deep tissue heating without negatively impacting the diathermic profile during SAM treatment.

Project description:BackgroundWearable 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.MethodsNinety 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).ResultsThe 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.ConclusionsLong-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 registrationNCT02083861, registered 11 March 2014, https://clinicaltrials.gov/ct2/show/results/NCT02083861.

Project description:BackgroundExperimental and clinical evidence support a link between body representations and pain. This proof-of-concept study in people with painful knee osteoarthritis (OA) aimed to determine if: (i) visuotactile illusions that manipulate perceived knee size are analgesic; (ii) cumulative analgesic effects occur with sustained or repeated illusions.MethodsParticipants with knee OA underwent eight conditions (order randomised): stretch and shrink visuotactile (congruent) illusions and corresponding visual, tactile and incongruent control conditions. Knee pain intensity (0-100 numerical rating scale; 0 = no pain at all and 100 = worst pain imaginable) was assessed pre- and post-condition. Condition (visuotactile illusion vs control) × Time (pre-/post-condition) repeated measure ANOVAs evaluated the effect on pain. In each participant, the most beneficial illusion was sustained for 3 min and was repeated 10 times (each during two sessions); paired t-tests compared pain at time 0 and 180s (sustained) and between illusion 1 and illusion 10 (repeated).ResultsVisuotactile illusions decreased pain by an average of 7.8 points (95% CI [2.0-13.5]) which corresponds to a 25% reduction in pain, but the tactile only and visual only control conditions did not (Condition × Time interaction: p = 0.028). Visuotactile illusions did not differ from incongruent control conditions where the same visual manipulation occurred, but did differ when only the same tactile input was applied. Sustained illusions prolonged analgesia, but did not increase it. Repeated illusions increased the analgesic effect with an average pain decrease of 20 points (95% CI [6.9-33.1])-corresponding to a 40% pain reduction.DiscussionVisuotactile illusions are analgesic in people with knee OA. Our results suggest that visual input plays a critical role in pain relief, but that analgesia requires multisensory input. That visual and tactile input is needed for analgesia, supports multisensory modulation processes as a possible explanatory mechanism. Further research exploring the neural underpinnings of these visuotactile illusions is needed. For potential clinical applications, future research using a greater dosage in larger samples is warranted.

Dataset Information

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

Background

Methods

Results

Conclusion

Publications

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

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