The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis.

OBJECTIVE: The MOTION study is designed to measure the impact of percutaneous image-guided lumbar decompression as a first-line therapy on patients otherwise receiving real-world conventional medical management for lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. This prospective, multicenter randomized controlled trial uses objective and patient-reported outcome measures to compare the combination of the mild® percutaneous treatment and nonsurgical conventional medical management (CMM) to CMM-Alone. METHODS: Test group patients received the mild procedure after study enrollment. Test and control groups were allowed conventional conservative therapies and low-risk interventional therapies as recommended by their physicians. Subjective outcomes included the Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire. Objective outcomes included a validated Walking Tolerance Test, the rate of subsequent lumbar spine interventions, and safety data. RESULTS: Two-year follow-up included 64 mild + CMM and 67 CMM-Alone patients. All outcome measures showed significant improvement from baseline for mild + CMM, whereas the majority of CMM-Alone patients had elected to receive mild treatment or other lumbar spine interventions by 2 years, precluding valid 2-year between-group comparisons. Neither group reported any device- or procedure-related adverse events. CONCLUSIONS: The durability of mild + CMM for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure-related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure.

Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial.

BACKGROUND: Lumbar spinal stenosis (LSS) is a serious degenerative condition of the spine that can cause significant functional disability. Therapies for these patients generally begin with conservative management, since more invasive interventions such as open surgery and spinal implants are associated with higher complication rates. Early in the treatment algorithm for LSS patients, multiple conventional medical management (CMM) therapies are often combined as an initial low-risk treatment strategy. This composite first-line treatment plan may include conservative care together with early interventional treatment options such as epidural steroid injections, radiofrequency ablation and the mild ® Procedure. METHODS: This prospective randomized controlled trial evaluates patients aged 50 to 80 years treated with mild plus CMM, compared to those treated with CMM alone, as the active control. Walking tolerance test outcomes and incidence of subsequent disallowed procedures provided objective real-world outcome data. The incidence of device or procedure-related adverse events was analyzed. Follow-up includes 6-month, 1-year and 2-year assessments, with 1-year being primary. Patients in the mild+CMM group are followed at 3, 4, and 5 years. This is a report of interim 6-month outcomes. RESULTS: Of 155 patients enrolled at 19 US interventional pain management centers, 78 were allocated to CMM-Alone, and 77 to mild+CMM. At 6-months, the validated walking tolerance test demonstrated statistical superiority of mild+CMM versus CMM-Alone (p<0.001). The incidence of patients receiving a subsequent disallowed procedure, and thereby considered treatment failures in their study group, was statistically significantly higher in CMM-Alone versus mild+CMM (p<0.001). There were no device or procedure-related adverse events in either group. CONCLUSION: At 6-months, the mild Procedure combined with CMM provided statistically superior objective real-world outcomes versus CMM-Alone. There were no device or procedure-related adverse events reported in either study group. With its excellent safety profile and superior efficacy, mild is uniquely positioned as early first-line therapy.

Efficacy of inpatient burn rehabilitation: a prospective pilot study examining range of motion, hand function and balance.

PURPOSE: To examine the effect of inpatient rehabilitation therapy on range of motion, hand function and balance in the burn population. METHODS: This study utilizes a prospective longitudinal design. Inclusion criteria are adults admitted to a regional inpatient rehabilitation hospital with a primary diagnosis of burn injury. Demographic and medical data are collected. Primary outcomes include range of motion at four joints (shoulder, elbow, hip, knee), hand function (Jebsen Taylor Hand Test) and balance (Berg Balance Scale). Outcomes are measured at admission and discharge. Students't-test is used to determine significant differences in outcomes from admission to discharge. RESULTS: Eleven subjects meet inclusion criteria. The mean age is 50 years, rehabilitation length of stay is 35 days and total body surface area burned is 41%. Subjects demonstrate significant improvements in range of motion, hand function and balance from admission to discharge (p<0.05). CONCLUSIONS: Specific functional measures, range of motion, hand function and balance, demonstrate significant improvement during inpatient rehabilitation. Future work is needed to investigate other functional benefits of rehabilitation and to compare the impact of inpatient rehabilitation to other therapeutic interventions.

Neurologic and musculoskeletal complications of burn injuries.

As more people survive burn injuries, there is an increasing focus on managing the complications of burn injuries with the ultimate goal of improving survivors' quality of life. Musculoskeletal and neurologic sequelae are significant complications of burn injury. Electrical injury is a subcategory of burns with multiple musculoskeletal and neurologic complications. Knowledge of these complications helps clinicians provide optimal long-term care for burn survivors and enables survivors to attain maximal recovery.