PURPOSE. To compare functional outcomes, union and complication rates in patients treated with locked intramedullary nailing or dynamic compression plating for humeral shaft fractures. METHODS. 32 men and 2 women with humeral shaft fractures were randomised to undergo locked antegrade intramedullary nailing (IMN, n=16) or dynamic compression plating (DCP, n=18). Patients with pathological fractures, grade-III open fractures, neurovascular injury, or fractures for more than 2 weeks were excluded. Fractures were classified according to the AO classification system (one in A1, 6 in A2, 12 in A3, 6 in B1, and 9 in B2). 28 were injured in road traffic accidents. The functional outcome (according to the American Shoulder and Elbow Surgeons [ASES] score) and rates of union and complication of the 2 groups were compared. RESULTS. All patients were followed up for a minimum of 24 months. In the respective IMN and DCP groups, the mean ASES scores were 45.2 and 45.1 (p=0.69), the complication rates were 50% and 17% (p=0.038), and the non-union rates were 0% and 6% (p=0.15). In the IMN group, 2 sustained iatrogenic fractures during nail insertion; 2 had transient radial nerve palsies; one underwent nail removal for shoulder impingement; and 3 had adhesive capsulitis. In the DCP group, one underwent re-operation for implant failure; one had a superficial infection; and one developed adhesive capsulitis. CONCLUSION. The complication rate was higher in the IMN group, whereas functional outcomes were good with both modalities.
Introduction
Low back pain is a common problem worldwide causing deterioration of health and quality of life. Low back pain is often associated with muscle spasm. We investigated the combined effect of muscle relaxants and pain killers for low back pain.
Methods
In this open-label, prospective, multicenter study, patients with acute low back pain received a single tablet of either the fixed dose combination of chlorzoxazone 500 mg and ibuprofen 400 mg (manufacturer: Dr. Reddy’s Laboratories, India) (C + I group) or ibuprofen 400 mg (I group) thrice daily for up to 7 days. Primary outcomes were improvement in pain by Visual Analogue Scale (VAS) and Summed Pain Intensity Difference (SPID) at 3 and 7 days post-treatment.
Results
A total of 406 patients were included in this study. When compared to baseline, the absolute mean change in VAS scores on Day 7 was 62.39 ± 18.78 and 57.34 ± 16.29 in the C + I and I groups, respectively (
P
= 0.0001). In the C + I and I groups, the mean SPID at Days 3 and 7 were 51.27 ± 24.44 and 47.80 ± 22.91, and 300.82 ± 92.40 and 277.16 ± 81.83, respectively. No deaths or serious adverse events were reported. Common adverse events included gastritis, stomach pain, fever, cold, and headache. At the end of the study, excellent to good response was reported in 94.08% and 77.33% of patients in the C + I and I groups, respectively. Excellent to good tolerability was observed in 96.05% and 89.65% patients in the two groups, respectively.
Conclusion
Fixed dose combination of chlorzoxazone and ibuprofen demonstrated superior efficacy than ibuprofen monotherapy in acute low back pain. Both drugs were well-tolerated and should be considered as judicious therapeutic options in patients with acute low back pain.
Trial Registration
This trial is registered with Clinical Trial Registry of India—CTRI/2016/10/007348.
Funding
Dr. Reddy’s Laboratories Ltd.
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