Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: a non-inferiority randomized control trial.

BACKGROUND CONTEXT: Low back pain with or without radicular leg pain is an extremely common health condition significantly impacting patient's activities and quality of life. When conservative management fails, epidural injections providing only temporary relief, are frequently utilized. Intradiscal oxygen-ozone may offer an alternative to epidural injections and further reduce the need for microdiscectomy. PURPOSE: To compare the non-inferiority treatment status and clinical outcomes of intradiscal oxygen-ozone with microdiscectomy in patients with refractory radicular leg pain due to single-level contained lumbar disc herniations. STUDY DESIGN / SETTING: Multicenter pilot prospective non-inferiority blocked randomized control trial conducted in three European hospital spine centers. PATIENT SAMPLE: Forty-nine patients (mean 40 years of age, 17 females/32 males) with a single-level contained lumbar disc herniation, radicular leg pain for more than six weeks, and resistant to medical management were randomized, 25 to intradiscal oxygen-ozone and 24 to microdiscectomy. 88% (43 of 49) received their assigned treatment and constituted the AS-Treated (AT) population. OUTCOME MEASURES: Primary outcome was overall 6-month improvement over baseline in leg pain. Other validated clinical outcomes, including back numerical rating pain scores (NRS), Roland Morris Disability Index (RMDI) and EQ-5D, were collected at baseline, 1 week, 1-, 3-, and 6-months. Procedural technical outcomes were recorded and adverse events were evaluated at all follow-up intervals. METHODS: Oxygen-ozone treatment performed as outpatient day surgeries, included a one-time intradiscal injection delivered at a concentration of 35±3 µg/cc of oxygen-ozone by a calibrated delivery system. Discectomies performed as open microdiscectomy inpatient surgeries, were without spinal instrumentation, and not as subtotal microdiscectomies. Primary analyses with a non-inferiority margin of -1.94-point difference in 6-month cumulative weighted mean leg pain NRS scores were conducted using As-Treated (AT) and Intent-to-Treat (ITT) populations. In post hoc analyses, differences between treatment groups in improvement over baseline were compared at each follow-up visit, using baseline leg pain as a covariate. RESULTS: In the primary analysis, the overall 6-month difference between treatment groups in leg pain improvement using the AT population was -0.31 (SE, 0.84) points in favor of microdiscectomy and using the ITT population, the difference was 0.32 (SE, 0.88) points in favor of oxygen-ozone. The difference between oxygen-ozone and microdiscectomy did not exceed the non-inferiority 95% confidence lower limit of treatment difference in either the AT (95% lower limit, -1.72) or ITT (95% lower limit, -1.13) populations. Both treatments resulted in rapid and statistically significant improvements over baseline in leg pain, back pain, RMDI, and EQ-5D that persisted in follow-up. Between group differences were not significant for any outcomes. During 6-month follow-up, 71% (17 of 24) of patients receiving oxygen-ozone, avoided microdiscectomy. The mean procedure time for oxygen-ozone was significantly faster than microdiscectomy by 58 minutes (p<.0010) and the mean discharge time from procedure was significantly shorter for the oxygen-ozone procedure (4.3±2.9 hours vs. 44.2±29.9 hours, p<.001). No major adverse events occurred in either treatment group. CONCLUSIONS: Intradiscal oxygen-ozone chemonucleolysis for single-level lumbar disc herniations unresponsive to medical management, met the non-inferiority criteria to microdiscectomy on 6-month mean leg pain improvement. Both treatment groups achieved similar rapid significant clinical improvements that persisted and overall, 71% undergoing intradiscal oxygen-ozone were able to avoid surgery.

Gait analysis 6 and 12 months after anterior cruciate ligament reconstruction surgery.

Little is known about knee function after anterior cruciate ligament reconstruction in the vital activities of walking and stair use. Gait analysis was done on patients 6 months (n = 8) and 12 months (n = 9) after reconstruction of the anterior cruciate ligament. Paired t tests were used to compare the injured and uninjured knees. During level walking, the patients placed external flexion torques on their injured knees throughout midstance, indicating the absence of quadriceps avoidance gait. The peak external flexion torque (resisted by the knee extensor muscles) placed on the injured knee was significantly less than that of the uninjured knee when ascending stairs (at 12 months, 68.4 and 85.3 N-m in the injured and uninjured knees, respectively) and also when descending stairs (at 12 months, 70.8 and 81.7 N-m in the injured and uninjured knees, respectively). The injured knee produced significantly less power than the uninjured knee when ascending stairs, but this difference was not significant when descending stairs. These findings indicate that asymmetric gait patterns persisted up to 1 year after surgical reconstruction and were more pronounced during stair ascent and descent than in level walking. These results indicate that clinicians should include specific interventions targeted at improving knee function during stair use to restore normal function after anterior cruciate ligament reconstruction.

Range of motion specificity resulting from closed and open kinetic chain resistance training after anterior cruciate ligament reconstruction.

The purpose of this study was to examine whether joint angle specificity occurs in open and closed kinetic chain resistance training of the knee extensors after anterior cruciate ligament reconstruction (ACLR). Isokinetic knee extensor strength was measured at 60 and 210 degrees.s(-1) in 32 patients, 2 and 6 weeks after surgery. Between test sessions, patients participated in a 4-week program of injured leg resistance training of the knee extensors in either open kinetic chain (OKC) knee extension or leg press exercises. Isokinetic testing knee range of motion (ROM) was divided into 5 equal portions from flexion to extension, and the mean torque was calculated over those divisions: 0-20%, 20-40%, 40-60%, 60-80%, and 80-100% ROM. Analysis of variance indicated that there were no significant differences between patients in the knee extension or leg press exercise groups.

Three dimensional moments in the lumbar spine during asymmetric lifting.

OBJECTIVE: To better understand the loads placed on the spine during asymmetric lifting. DESIGN: Analysis of variance was used to test the effects of asymmetry (0, 45, 90 degrees ), event (up, down, min and max), and trial (first and second) on applied spine moments and resulting EMG signals in the lumbar spine. BACKGROUND: Loading conditions resulting from symmetric lifting are well documented in the literature, yet free-style asymmetric tasks have not been intensively studied. METHODS: Infrared markers and EMG electrodes were fixed to ten subjects. Subjects were asked to lift a 45 N weight from three different positions in relation to the sagittal plane. External loads on the L3-L4 and L4-L5 disc planes were calculated. Maximum moments and EMG were compared with those at lift off and set down of the burden. All lifts were repeated twice. RESULTS: Introducing asymmetry to the lift increased lateral bending and twisting moments. Flexion moments increased by approximately 5% after lift off of the load. During the second repetition of the lift, flexion and twisting moments decreased and increased, respectively. EMG signals were greater on the contralateral side during asymmetric lifts. CONCLUSIONS: Asymmetric lifting places complex loads across the trunk, which may become increasingly asymmetric with repeated trials. RELEVANCE: Individuals should take precautions to perform lifts in a symmetric manner and to avoid repetitive asymmetric lifting if possible. Past study indicated that twisting and lateral bending loads, when coupled with flexion loads, resulted in much greater disc compression and should be avoided. This work described the degree to which lateral bending and twisting loads were introduced as lifts deviated from the sagittal plane.

Biomechanical changes in the low back following reduction mammaplasty surgery.

OBJECTIVE: To give evidence of the mechanical consequences of reduction mammaplasty (RM) on the low back. DESIGN: A repeated-measures analysis was implemented to test the effect of RM on the external loads and angular velocity of the back during both static and dynamic lifting tasks. BACKGROUND: Patient follow-up surveys have documented a decrease in the frequency of low back pain following RM, but there is no quantitative data regarding biomechanical changes following surgery. METHODS: Patients were evaluated before and 4-8 weeks following RM. Flexion moment, compression and shear forces at L3-L4 were quantified for isometric flexion angles between 0 and 40 degrees. External loads and angular velocities of the back were studied during rapid dynamic lifting tasks. RESULTS: Isometric external flexion moments at L3-L4 decreased following RM. RM did not effect the applied flexion moment in the lumbar spine, but a trend suggested that RM resulted in increased lifting velocity. CONCLUSIONS: RM does act to reduce the loads on the lumbar spine during simple isometric tasks. During dynamic tasks, subjects may be able to lift faster without generating larger loads.