Evaluation of the efficacy and safety of NVP-1203 and aceclofenac in patients with acute low back pain and muscle spasm: A randomized, double-blind, active-controlled, parallel, multicenter, phase 3 clinical trial.

OBJECTIVE: Acute low back pain (LBP) is a common condition that can be chronic if not properly treated. Aceclofenac and eperisone hydrochloride are commonly prescribed drugs for acute LBP and muscle spasms. Therefore, NVP-1203, a fixed-dose combination of 100 mg aceclofenac and 75 mg eperisone hydrochloride, is being developed. This study aimed to evaluate the efficacy and safety of NVP-1203 compared to those of a single administration of 100 mg aceclofenac in patients with acute LBP and muscle spasms. PATIENTS AND METHODS: Overall, 455 patients with acute LBP and muscle spasms were enrolled. The patients were assigned to NVP-1203 or Airtal group (aceclofenac 100 mg). The primary efficacy endpoint was the mean change in the 100 mm pain movement and resting visual analog scale (VAS) scores on treatment day 7. RESULTS: The mean change in the 100 mm pain movement/resting VAS scores from baseline to day 7 was -49.7 ± 21.5/-41.0 ± 19.4 mm and -38.8 ± 18.9/-33.8 ± 18.0 mm for the NVP-1203 and Airtal groups, respectively. The differences between the two groups were statistically significant (movement, p < 0.0001; resting, p = 0.0002). Differences in least-square (LS) mean change of the 100 mm pain movement/resting VAS score between the two groups using the analysis of covariance (ANCOVA) model was -10.2/-7.4 mm, and the upper limit of the 95% confidence interval was -6.44/-4.16 mm. CONCLUSIONS: NVP-1203 is more effective in reducing pain than the 100 mg aceclofenac alone. However, the two drugs have similar safety profiles in patients with acute LBP and muscle spasms.

The outcomes of instrumented posterolateral lumbar fusion in patients with rheumatoid arthritis.

AIMS: The aims of this study were to evaluate the clinical and radiological outcomes of instrumented posterolateral fusion (PLF) performed in patients with rheumatoid arthritis (RA). METHODS: A total of 40 patients with RA and 134 patients without RA underwent instrumented PLF for spinal stenosis between January 2003 and December 2011. The two groups were matched for age, gender, bone mineral density, the history of smoking and diabetes, and number of fusion segments. The clinical outcomes measures included the visual analogue scale (VAS) and the Korean Oswestry Disability Index (KODI), scored before surgery, one year and two years after surgery. Radiological outcomes were evaluated for problems of fixation, nonunion, and adjacent segment disease (ASD). The mean follow-up was 36.4 months in the RA group and 39.1 months in the non-RA group. RESULTS: Both groups had significant improvement in symptoms one year after surgery, while the RA group showed some deterioration of outcome scores owing to complications during the second year after surgery. Complications occurred at a higher rate in the group with RA (19 patients, 47.5%) than in those without RA (23 patients, 17.1%) (p < 0.001). A total of 15 patients in the RA group (37.5%) required revision surgery, mainly for implant failure and post-operative infection. DISCUSSION: Multimodal approaches should be considered when performing instrumented PLF in patients with RA to reduce the rate of complications, such as problems of fixation, post-operative infection and nonunion. TAKE HOME MESSAGE: Specific strategies should be undertaken in order to optimise outcomes in patients with rheumatoid arthritis.

Intra-articular ganglion cysts of the knee.

A ganglion is a cystic mass with myxoid matrix that occasionally occurs within muscles, tendons, and menisci. A ganglion cyst within the knee is very rare, with few reports to be found. We are reporting eight cases of a ganglion within the knee joint. Our cases include two ganglia in the infrapatellar fat pad which have not been previously reported. Ganglion cysts do not have specific symptoms. We hypothesize that symptoms of a ganglion cyst may correlate with the size and the location within the knee joint. The diagnosis of ganglia within the knee was established by magnetic resonance imaging study and confirmed by pathological testing. All the patients were treated successfully using the arthroscopic technique.

Symptomatic ganglion cyst within the substance of the anterior cruciate ligament.

Many previous investigators have reported the findings of ganglion cysts on the surface of the anterior cruciate ligament. The cysts reported in the literature were either symptomatic or only of incidental findings. So far, however, there has not yet been a report of a ganglion cyst within the substance of the anterior cruciate ligament. This is the first report of a ganglion cyst within the substance of the anterior cruciate ligament, which caused intermittent swelling and pain in the right knee of a 13-year-old girl without any history of trauma. The cyst was treated successfully with an arthroscopic debridement and arthroscopically guided needle aspiration.