N.2 Designing a device: Shoulder pain management through stereotactic thermomechanical stimulation

Post-operative or post-injury pain management through stereotactic thermomechanical stimulation

Acute inadequately treated pain after surgery continues to be a public health problem: 80% of patients hospitalized experience significant pain, and pain is the primary reason for dissatisfaction and poor mobility after orthopedic surgery.[4-6] Pain affects almost 30% of the population,[1] with an economic impact estimated to cost 600B in lost productivity, morbidity, and healthcare costs.[2] Shoulder pain from rotator cuff injuries and post-operative shoulder pain (rotator cuff repair, labral repair, stabilization/Bankart repair, debridement) require more outpatient opioids than other surgeries, and are the greatest source of unmet post-op pain relief needs, according to NIAMS program director. Between 8 and 26% of adults in the US have shoulder pain at any given time.

Opioid medications, the mainstay of acute and chronic pain relief, have been increasingly associated with overdose deaths[7 8] with poor support for efficacy and high risks of tolerance.[3] NSAIDS cause bleeding and ulceration in a significant proportion of older patients.  Cryotherapy and mechanical stimulation (cold with vibration) are independently associated with reduced pain and opioid use after surgery, but the combination has not been feasible for the complicated anatomy of the shoulder. Pressure, surface area, stimulus torque orientation, and amplitude are all variables impacting delivery of optimal pain relief. While optimal frequencies have been determined for neuromodulatory M-stim pain relief, the potential for stereotactic amplification of pain relief has not been studied due to the difficulty of attachment in the shoulder. Compliance with opioid sparing Enhanced Recovery After Surgery, or ERAS, has particular barriers with shoulder surgery given the lack of easily conforming physical and cryotherapy interventions, as agency and immediate efficacy enhance pain relief. As physicians limit opioids, the lack of a proven patient-controlled option for pain relief is a critical barrier to reducing shoulder injury and post-surgical pain.  

This project will develop a device capable of delivering both vibration and thermal relief after shoulder injury or surgery. It is anticipated that the researchers will develop an adjustable form allowing for self-application of direct pain mitigation to two locations simultaneously, with heat up to 40C for spasm and cold down to 5C for cryotherapy.  It is envisioned that the embodiment will allow for application without interfering with sleep, and allowing for one device to be capable of fitting adolescents 12 and up through large adults. The investigators will work closely with the physician-inventor, orthopedic shoulder injury patients, and patients with chronic shoulder pain from oveuse to optimally configure a solution. The stereotactic configuration will be the first of its kind, advancing the field of M-Stim. If successful, this intervention can mitigate pain and opioid use disorder for millions worldwide

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