A clinical trial to study the effects of two drugs, Fixed Dose Combination of Etoricoxib and Thiocolchicoside and Thiocolchicoside Alone in Patients with Painful Muscle Spasm such as torticollis, lumbago, backache.

Not Applicable

Not yet recruiting

Brief Summary: Muscle Spasms are characterized by a high prevalence in the general population. Muscle spasm usually accompanies degenerative or inflammatory diseases of the musculoskeletal system and is defined as a sustained involuntary contraction which is usually painful and cannot be relieved completely by voluntary effort.

Painful muscle spasms, such as torticollis, lumbago, backache, neuralgias are treated with short term use of centrally acting muscle relaxants combined with analgesics, but efficacy and tolerability is not impressive.

Thiocolchicoside is a centrally acting muscle relaxant having unique additional analgesic action. Its sedative property is also negligible and has less adverse effects compared to the others in its group.

Etoricoxib is a newer selective COX-2 inhibitor, with gastroprotection being its advantage over other traditional NSAIDS.

Though widely used for the above indications, there appears to be no published clinical study comparing the efficacy and tolerability with the intended study drugs, hence the present study is taken up to generate valid and useful data.

Recruitment & Eligibility

Inclusion Criteria

1.Subjects between 18-65yrs of age of either gender with painful muscle spasms attending Orthopaedic OPD.
2.Willingness to give written informed consent and available for regular follow up and examination.

Exclusion Criteria

1.Patients with history of liver and kidney damage, cardiovascular disease, acid peptic diseases 2.Pregnant and lactating mothers 3.Patients allergic to NSAIDS and skeletal muscle relaxants or prior history of asthma or hypersensitivity potentially requiring concomitant treatment 4.Patients treated with NSAIDS or skeletal muscle relaxants 1 week prior to study 5.Patients with severe concurrent systemic diseases including bleeding diathesis, on anticoagulant therapy.
6.Patients with malignancy, osteoporosis or previous history of lumbar spine surgery.

Primary Outcome Measures

Name	Time	Method
â€¢The primary efficacy end point of the drug therapy for the intended purpose of treatment will be evaluated through pain assessment scale using VAS	VAS will be assessed at baseline, 3rd day and 7th day visit to the OPD

Secondary Outcome Measures

Name	Time	Method
secondary efficacy end point by patients global assessment in response to treatment (PGART)	â€¢Patients Global assessment in response to treatment-PGART, is measured at the end of the study on a scale of 0 to 4.

Locations (1): KIMS, Bangalore-560070
🇮🇳
Bangalore, KARNATAKA, India
KIMS, Bangalore-560070
🇮🇳Bangalore, KARNATAKA, India
PRIYANKA S
Principal investigator
9844093100
drpriyanka110@gmail.com