The purpose of this study is to investigate the effects of a fixed dose combination of diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in patients with low back pain.
This study is an observer-blind, prospective randomized, controlled study to evaluate efficacy and safety of fixed dose combination of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg three times daily with plain eperisone hydrochloride 50 mg three times daily in patients with musculoskeletal spasm associated with low back pain. A total of 240 adult patients of either sex, 120 patients in each arm, who fulfill the inclusion and exclusion criteria will be included in this study. The patients will be evaluated at Days 3, 7 and 10 of the study visit for efficacy and safety. The efficacy evaluation includes objective parameters like Finger-to-Floor distance, Lasegue's sign, tenderness of par vertebral muscles, lumbar and dorsal hypermyotonia, leg tendon reflexes, need for rescue medication and subjective parameters like improvement in lumbar cinesalgia, pain in lower extremities, sensory disturbances of lower limb, and Global Assessment of Response to Therapy (PGART). Patients will be evaluated for safety on the clinical adverse events reported during the study period, sedation on drowsy alert scale and Global Assessment of Tolerability to Therapy (PGATT). The patients will also be evaluated for laboratory safety as assessed by measuring laboratory parameters for hemogram, renal and hepatic parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
239
Fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given 3 times a day after meals for 7 to 10 days
eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days
Department of Orthopedics, Government Medical College
Aurangabad, Maharashtra, India
Deore Hospital
Aurangabad, Maharashtra, India
Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals
Mumbai, Maharashtra, India
Kabre Orthopedic, Spine & Dental Care
Pune, Maharashtra, India
Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline.
Improvement in the Fingertip-to-Floor-surface Distance \[FFD\] from baseline on Day 3, Day 7 \& Day 10. Finger Floor Distance \[FFD\] is an index for the mobility of the lumbar spinal cord and is measured as the distance between the finger-tip of the middle Finger to the Floor-surface as determined while standing with the spinal cord flexed with complete extension of knee joint. It is measured in millimeters.
Time frame: Day 1,3,7 and 10 of study period
Objective Efficacy Assessment: Improvement in Lasegue's sign compared to baseline
Lasegue's sign is the lumbar pain \[or exacerbation of existing pain\] experienced by the patient on passive movement of the legs during flexion of hip joint i.e. passive straight leg raising. It is assessed as either 'Positive' or 'Negative' sign.
Time frame: Day 1, 3, 7 and 10 of study period
Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline
Improvement in Lumbar Cinesalgia (pain in lumbar region) assessed on a 0 to 100mm Visual Analogue Scale (VAS) with '0' representing 'NO PAIN' and 100 representing 'SEVERE INTOLERABLE PAIN'
Time frame: Day 1, 3, 7 and 10 of study period
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