Patients

Patients Ganetespib mechanism were excluded if they fulfilled the following exclusion criteria: (i) had signs and symptoms that warrant early surgical intervention (caudaequina syndrome, severe motor deficits, hyperalgesia); (ii) had CT scan evidence of signs and symptoms from causes other than a herniated nucleus pulposus; (iii) had received any previous epidural corticosteroid injections for the present episode; (iv) had undergone lower back spinal surgery; (v) pregnant patients; (vi) had a known allergy to corticosteroid or butorphanol; or (vii) had a known bleeding disorder. Treatment The patients received epidural injections of either 80 mg (2 mL) of methylprednisolone acetate and 1 mg (1 mL) of butorphanol diluted with 7 mL of isotonic saline, or 80 mg (2 mL) of methylprednisolone acetate diluted with 8 mL of isotonic saline by a lumbar interlaminar approach under fluoroscopic guidance.

The injections were repeated on third and sixth weeks in the patients who continued to have scores higher than 30 mm on VAS. After the first injection, patients were supplied with paracetamol tablets (500 mg) for using as and when required basis. Blinding The doctors making the follow-up assessment were unaware of the treatment received, and none of the doctors who administered the injections carried out the follow-up evaluations. Thus both the patients and the assessing doctors were remained unaware of the treatment received throughout the trial. Follow-up and outcome measure The patients were re-evaluated as outpatients at 3 weeks, 6 weeks, and 3 months after the first injection.

Follow-up assessment of each patient was done by the same doctor throughout the trial. At each follow-up visit, the following information was recorded as outcome measures: (i) Information on the use of paracetamol; (ii) intensity of pain on a VAS ranging from 0 (no pain) to 100 mm (worst pain possible); (iii) Schober’s test (cm); (iv) SLR test; (v) neurological examination assessing sensory deficits, motor deficits, and reflex changes; and (vi) Oswestry Low Back Pain Disability Questionnaire.[18] Sample size We selected the visual analog pain score as the primary outcome measure at 3 months. We estimated that, in order to detect a 12 mm difference in the mean visual analog pain score (with a two-sided Entinostat alpha value of 5%, a statistical power of 80% and a standard deviation of 26, as estimated U0126 MAPK in an initial study of 50 patients with sciatica) between the 2 groups, at least 48 patients had to be recruited in each group. We therefore planned to enroll 60 patients in each group considering for an expected maximum withdrawal rate of 20%.

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