Table 1 The clinical studies conducted evaluating SAM in upper shoulder, neck and back pain in different demographics

Study design

Randomized double-blind study

Non-randomized study

Randomized double-blinded study

Demographics

Sample size (n = 30), active (n = 20, 10 males, 10 females), placebo (n = 10, 9 male, 1 female)

Sample size (n = 5), gender not available

Sample size (n = 33), active (n = 25, 9 males, 16 females), placebo (n = 8, 3 males, 5 females)

Clinical criteria

Trapezius Myofascial Pain

Inclusion criteria: age 40–60 years, physician clearance, patient consent, physician clearance, unable to self-administered treatment daily, able to record changes in pain score (VAS: 40–70)

Exclusion criteria: Neuropathy, psychologically unstable, pregnancy, prisoner, surgery within last 6 months, no use of topical agents during and past 30 days of treatment, surgery or injury, other severe pain, self-evaluation of the trapezius myalgia

Rotator Cuff Tendinopathy

Inclusion criteria: age > 40, Physician’s diagnosed rotator cuff pain (tendinosis, tear, tendonitis, adhesive capsulitis, biceps tenosynovitis, proximal humerus fracture), limited shoulder mobility, taking pain medication at least one week before treatment

Exclusion criteria: Metastatic or infectious shoulder pathology, cervical radiculopathy, unable to utilize the device, cognitively impaired

Upper Shoulder and Neck Pain

Inclusion criteria: age 30–36 years, diagnosed for upper trapezius trigger point by a health practitioner or trainer, NRS ≥ 3 out of 10, restricted mobility

Exclusion criteria: Neuropathy, type I/II diabetes, surgery within last 6 months at the treatment site, skin irritation to ultrasound gel. Instructed to stop other topical analgesics, discontinue other pain medication if possible

Methodology

SAM therapy for at least 1-h treatment at the onset of trapezius spasm, all the treatments were conducted at home, patient convenience, VAS metrics were recorded daily by patients, and GROC was recorded at the end of the study. At least 10 treatments with 100% compliance

SAM therapy daily, 4 h, over 12 treatments

SAM therapy over 4 h. The double-blinded and random distribution was conducted based on baseline NRS and GROC. Patients recorded changes in pain in a daily dairy

Outcomes

VAS (0–100 mm scale)

GROC (over 10 days) (pre and post each treatment: − 7 to 7)

Pain reduction post-treatment (120 min treatment)

VAS (1–100 mm scale)

GROC (pre and post per treatment: − 7 to 7)

NRS: (1–10 scale)

GROC: (pre and post per treatment: − 7 to 7)

Main findings

VAS: The most pain reduction was in the first 2 days (active mean 21.25% ± 9%, placebo mean 4% ± 9%, p < 0.05), over 10 treatment (active mean 16% ± 7.5% vs. placebo mean 7.5% ± 7.5%, p < 0.05)

GROC: 60% improvement relative to placebo over 10 days treatments. Males were more responsive to treatment than females (p < 0.05)

Post-treatment pain reduction in males was 78% and females 52% over the first hour (p < 0.05)

VAS: 30% improvement over 12 sessions on scale (p < 0.05)

VAS: 52% improvement over starting VAS score (p < 0.05)

GROC: 52% improvement over 12 sessions (p < 0.05)

NRS: Over 4 weeks of treatment, patients reported 2.61 points to decrease (p < 0.001). pain decrease of 1.03 points over placebo treatment (p = 0.003)

GROC: 4-week treatment improvement by 2.84 points in the treated group relative to 0.46 in the placebo (p < 0.001)

Level of evidence

1C

4

1B

Downs and black score

21/28, good quality

11/28, poor quality

26/28, excellent quality

Conclusion

Clinical study reported the SAM efficacy in chronic trapezius myofascial pain. The primary outcomes VAS, GROC, and pain reduction post-treatment recommends further clinical studies. No adverse side effects

Preliminarily study reporting an increase in shoulder mobility, reduction in pain and improved quality of care with no placebo control

SAM treatment has clinically significant outcomes to reduce pain and improve quality of life at the study dosing protocol