Table 3 Soft tissue is highly heterogeneous, including skeletal muscle, smooth muscle, tendons, and ligaments
Reference | Taggart et al. [71] | Rigby et al. [55] | Best et al. [50] | Langer et al. [68] | Langer et al. [69] | Draper et al. [70] |
|---|---|---|---|---|---|---|
Study design | Safety and usability clinical study | Randomized placebo controlled clinical study | Clinical case series | Randomized cross-over placebo controlled clinical study | Clinical case series | Clinical case series |
Demographics | Sample size (n = 20), gender not available | Sample size (n = 26, 16 males, 10 females), active (n = 20), placebo (n = 6) | Sample size (n = 25, 11 males, 10 female), Achilles (n = 5), elbow (n = 20) | Sample size (n = 16) active (n = 16), placebo (n = 16), age 22 ± 2, (16 males) | Sample size (n = 44), normal BMI: arm (n = 11), leg (n = 11); high BMI: arm (n = 11), leg (n = 11) | Sample size (n = 18), age 30 ± 13.31, (13 males, 5 female) |
Clinical criteria | Home use of SAM treatment Inclusion criteria: 18 years of age or older, with the ability to read, write, and speak English Exclusion criteria: Individuals were excluded if they had a condition that was contraindicated for ultrasound therapy | Diathermic effects Inclusion criteria: Healthy subjects Exclusion criteria: patients with fever, lower leg infection or wound, lack of sensation. Participant were instructed not to exercise for 24 h prior to test | Soft tissue Injury Inclusion criteria: Age 16–65 years old, no NSAIDs, pain prescription pain during the study Exclusion criteria: no neuropathy, no type I or II diabetes, surgery at the treatment site, malignancy, use of topical agents, application of corticosteroid or platelet-rich plasma injection, medical or psychological condition, participate in no clinical trial in any other clinical trial for last 30 days, no trauma, open sores or wound at treatment site | Soft tissue Injury Inclusion criteria: Healthy subjects, age 20–24 years old, no NSAIDS, no massage, no nutritional supplements, previous resistance training experience Exclusion criteria: Not available | Diathermic effects Inclusion criteria: Healthy subjects Exclusion criteria: Not available | Soft tissue injury Inclusion criteria: Using adjunctive therapy, sports-related injury, and cognitively able to follow instructions Exclusion criteria: past surgeries, opioid-based medications, any implant, intramuscular or articular injections, and using NSAIDs |
Methodology | Participants evaluated SAM device in operation mode with one and two ultrasound transducers. Subjects were asked to use the device three times within a seven day period, each time for a four-hour treatment duration. After each treatment, subjects were asked to complete a 27-question quiz that assessed how the device was used, where it was applied, the ease of use, whether the device was operated successfully, and a discussion of any issues that may have been encountered while wearing the device | Participants were treated with one or two transducers. Two transducers were placed 8.5Â cm apart at room temperature, change in temperature was recorded at 1.5Â cm and 3Â cm intramuscular depth using thermocouplers (MT 23/5; Physitemp Instruments LLC, Clifton, NJ). Change in intramuscular temperature was continuously recorded for 3Â h. The study was conducted at room temperature | Injury sites were treated with SAM therapy, 4-h daily for 6Â weeks. Subject self-reported pain per day during treatment at 30Â min, 2Â h, and the end of treatment. A dynamometer was used to measure force generation and grip strength daily for elbow pathology | SAM therapy applied to the quadriceps and hamstrings for 1Â h prior to exercise, used throughout exercise and recovery after exercising up to 4Â h of SAM treatment. Exercise included two sets at 70% maximum of lunges, seated hamstring flexion, smith squats, seated quadriceps extension; and leg press. Blood-lactate measured at baseline and through workout and recovery periods. Muscle performance measured (total work, peak torque, and average power) in the dominant leg post exercise | Participants stratified into normal and high BMI. Applied SAM therapy on the arm or leg with two ultrasound transducers. On the arm SAM was applied to the elbow and forearm. On the leg, SAM was applied to the knee and calf. A temperature measurement thermocouple was placed between the SAM device and skin to measure temperature over 4Â h of treatment. Participants were asked to remain still during measurement to prevent excessive movement from disturbing thermocouple placement | Athletes were treated with SAM over 4Â h of adjunctive therapy. Duration of therapy was determined as required by physical therapy staff |
Outcomes | Device ease of use Subject overall experience Adverse events from use | Diathermic changes during SAM treatment | NRS pain (1–10 scale) Grip strength (N) and force generation (N) | Blood lactate levels (mmol·min·L−1) Ave Power (W) Total work (N-m) Peak Torque (N-m) | Diathermic changes during SAM treatment | NRS pain (1–10 scale) Quality of life Return to sport |
Main findings | 95% of subjects were able to successfully operate the device 93% of subjects thought the device was easy to use 90% of subjects had a positive experience overall 87% of subjects would use the device again No adverse events reported from treatment | 1 transducer treatment showed 4.45C increase at 1.5 cm and 3.18C at 3 cm over placebo 2 transducers increased intramuscular temperature by 3.95C at 1.5 cm and 3.22C at 3 cm over placebo | 3.94 point NRS decrease was reported in elbow tendinopathy (p = 0.002) 2.83 kg improvement in grip strength improvement (p = 0.04) Among 5 subjects with Achilles tendinopathy, a reduction in pain and improvement in strength was observed | Reduction of blood lactate by 20%, (255.8 ± 120.0 mmol min L−1) versus placebo condition (318.5 ± 86.0 mmol min L−1) p = 0.002 Increased average power (p = 0.024) Increased work (p = 0.031) Increased torque (p = 0.031) | Elbow: 12C temperature increase Forearm 12C temperature increase Knee 12C temperature increase Calf: 13C temperature increase | Athletes reported on average 3.33 point decrease in NRS pain score (p < 0.05) 87% improvement in function/quality of life, and 55% of were able to return to the sporting activity post-treatment |
Level of evidence | 4 | 2B | 4 | 2B | 4 | 4 |
Downs and black score | 19/28, good quality | 21/28, good quality | 21/28, good quality | 25/28, excellent quality | 16/28, fair quality | 15/28, fair quality |
Conclusion | SAM treatment holds the promise of providing non-pharmaceutical pain relief to patients suffering from a broad range of conditions. The device was successful in providing home ultrasound treatment, and 9:10 subjects who tried the device would use it again | SAM treatment increased the intramuscular temperature by 3°–4°. Further studies are required to assess physiological changes | SAM treatment shows potential as an effective treatment for elbow and Achilles’ tendinopathy. No adverse effects were reported | The use of SAM after exercised induced muscle damage can reduce lactic acid and improve some measurements of muscle performance in the lower extremities | SAM treatment provides over + 12C of diathermy while maintaining skin temperature at a maximum of 40C. SAM is a viable and safe treatment to delivering the biophysical effects of ultrasound | SAM therapy as adjunct therapy can expedite the rehabilitation process in musculoskeletal injuries |