CTRI/2018/11/016371.

Trial name or title	A comparative study of the efficacy and tolerability of fixed dose combination of etoricoxib and thiocolchicoside and thiocolchicoside alone in patients with painful muscle spasm
Methods	RCT, randomised, open‐label. Follow‐up time: 7 days
Participants	Population and setting: 100 participants with painful muscle spasms (such as torticollis, lumbago, backache) attending the orthopaedic outpatient department of a hospital in Bangalore, India Inclusion criteria: age 18 to 65 years, with painful muscle spasms, attending the orthopaedic outpatient department Exclusion criteria: history of liver and kidney damage, cardiovascular disease, asthma or acid peptic diseases, severe concurrent systemic diseases or anticoagulant therapy, malignancy, osteoporosis or a history of spine surgery, pregnancy or lactation, allergies or intolerances to NSAIDs and skeletal muscle relaxants, treatment with study medication 1 week prior to study enrolment
Interventions	NSAID (i): Etoricoxib (60 mg) + thiocolchicoside (4 mg; oral), b.i.d. for 7 days Reference treatment (ii): Thiocolchicoside (4 mg; oral), b.i.d. for 7 days
Outcomes	Pain (VAS). Patients' global assessment in response to treatment
Starting date	Not yet recruiting
Contact information	S. Priyanka; drpriyanka110@gmail.com
Notes