A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back pain.

BACKGROUND: Non-specific acute low back pain (LBP) is a common health problem that may be accompanied by muscle spasm and decreased mobility. The combination of non-steroidal anti-inflammatory drugs and muscle relaxants represents an advantageous therapeutic option, however, available data on their combined use are conflicting. This prospective, randomized, single-blind, two-parallel-group trial assessed the efficacy of a single intramuscular (IM) injection of the fixed-dose combination (FDC) diclofenac (75 mg)-thiocolchicoside (4 mg/4 ml) product (test treatment) compared to diclofenac (75 mg/3 ml) alone (reference treatment) for the symptomatic relief of acute LBP. Tolerability and safety were also assessed as secondary variables. METHODS: One hundred thirty-four patients were enrolled (safety population) and randomly allocated to the combination or single-agent regimen. Pain intensity and muscle spasm, assessed respectively by the patient-reported visual analogue scale and investigator-performed finger-to-floor distance test, were determined prior to the injection as well as 1 and 3 h post-injection in 123 patients (per-protocol population). The patients were blinded to treatment. Safety was assessed up to 24 h post-injection. RESULTS: The test treatment was superior in both alleviating the pain intensity and reducing the finger-to-floor distance at both 1 (p < 0.01 and p = 0.023 respectively) and 3 h post-injection (p < 0.01). A higher percentage of patients experienced > 30% reduction in pain intensity at 1 and 3 h with the test treatment (p = 0.037 and p < 0.01 respectively). The corresponding VAS (SD) scores for the test treatment group were at baseline, 1 and 3 h post-injection 72.03 (± 11.72), 45.37 (± 16.28) and 31.56 (± 15.08) respectively and for the reference treatment group 65.20 (± 12.16), 48.98 (± 18.76) and 44.52 (± 17.33) respectively. No adverse effects were reported with the combination treatment, whereas two patients treated with diclofenac reported dizziness. CONCLUSIONS: The FDC treatment is an effective and well-tolerated option for the symptomatic treatment of LBP. Clinical and patient-reported assessments confirmed that a single IM injection of FDC diclofenac-thiocolchicoside was more effective than diclofenac alone in conferring rapid and sustained improvement in mobility and pain intensity. TRIAL REGISTRATION: EudraCT No: 2017-004530-29 Available at https://eudract.ema.europa.eu/ Registered 04 Dec 2017.

A Solitary, Large Calcaneal Osteochondroma Growing Extensively After Skeletal Maturity: A Case Report and Review of the Literature.

Although osteochondromas are the most common benign tumors in the skeleton, calcaneal osteochondromas are very rare. New onset of pain or rapid growth of the tumor, especially after the closure of the epiphyseal growth plate, might reflect malignant transformation. However, enlargement of solitary osteochondromas reported as benign in a skeletally mature patient is present in the literature. We report the clinical and radiologic findings of a calcaneal osteochondroma with an extremely rare placement and painful rapid growth causing limited ambulation in a 27-year-old male. After surgical removal of the tumor, histologic examination demonstrated no evidence of malignancy, and there was no recurrence during the three-year follow-up.

Does electric stimulation of the vastus medialis muscle influence rehabilitation after total knee replacement?

Patients with knee osteoarthritis present with reduced quadriceps muscle strength, which is partially responsible for impaired function and disability. Although total knee replacement (TKR) is an effective surgical procedure, residual muscle weakness is not usually addressed and may persist for years postoperatively. This article reports the results of a prospective, randomized, controlled trial evaluating the effect of electric muscle stimulation of the vastus medialis on the speed and effort of walking, quality of life, and knee performance in patients undergoing TKR. Seventy patients who underwent TKR were randomly divided into 2 groups. Patients in group A received electric muscle stimulation and standard physiotherapy for 6 weeks, while patients in group B received physiotherapy only. All patients were assessed with both subjective and objective clinical scales preoperatively and at 6, 12, and 52 weeks postoperatively. Patients in group A demonstrated a statistically significant increase in walking speed, Oxford Knee Score, and American Knee Society function score compared to those in group B at 6 weeks (P=.003, .001, and .001, respectively) and at 12 weeks (all P=.001). A statistically significant increase in the SF-36 physical component summary score was observed at 6, 12, and 52 weeks (all P=.001). Three patients found the sensation of the electrical stimulation uncomfortable and abandoned its use. No skin reactions and surgical site infections were observed. Electrical stimulation of the vastus medialis muscle in addition to conventional physiotherapy improves functional recovery and early rehabilitation after TKR.

Effectiveness of electric stimulation of the vastus medialis muscle in the rehabilitation of patients after total knee arthroplasty.

OBJECTIVE: To investigate the possible effect of electric muscle stimulation (EMS) of the vastus medialis on the walking speed, Hospital for Special Surgery (HSS) knee score, and Physiological Cost Index (PCI) of patients during rehabilitation after total knee arthroplasty (TKA). DESIGN: Prospective, randomized controlled trial. SETTING: Various departments at a district general hospital in the United Kingdom. PARTICIPANTS: Thirty patients with unilateral osteoarthritis of the knee admitted for elective TKA were randomly assigned to 1 of 2 groups (15 per group): control and treatment. Both groups received standard physical therapy. The treatment group also received EMS of the vastus medialis. INTERVENTION: EMS (40Hz, 300micros) of the vastus medialis muscle for 4 hours a day, starting on postoperative day 2, over the first 6 postoperative weeks. MAIN OUTCOME MEASURES: Changes in walking speed, HSS knee score, and effort of walking as measured by the PCI. RESULTS: A statistically significant increase in walking speed was observed in the treatment group in relation to the control group at both 6 weeks (P=.0002) and 12 weeks (P<.0001) postoperatively. No statistically significant difference was observed in relation to the PCI or the HSS knee score variables. CONCLUSIONS: Application of EMS after TKA resulted in a statistically significant improvement in patients' walking speed. There was also a carry-over effect after the discontinuation of treatment.