A multiple centre study to check the efficacy and safety of Topical formulation of Diclofenac plus Thiocolchicoside in comparison with Diclofenac gel in acute low back pain.

Phase 3

Completed

• Conditions: In acute nonspecific Low back painful condition

• Registration Number: CTRI/2011/11/002116
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

This study was a randomised, two arm, open label, active controlled, multicentric clinical study to evaluate the safety and efficacy of a topical fixed dose combination of a muscle relaxant thiocolchicoside and a non steroidal anti inflammatory drug , diclofenac in comparison with diclofenac topical gel (1.16 w/w) in acute non specific low back pain in total of 150 patients at multiple sites in India. Patients were randomised to receive either diclofenac plus thiocolchicoside topical solution or  topical diclofenac gel. The primary outcome was pain relief with study medication, to be assessed on Day 3 . The secondary outcome was pain relief on Day 7, pain relief scores for the entire treatment period, Rolland Moris Disability score  along with patients & physicians global assessment  on Day 7. Pain relief on Day 3 and Day 7 of treatment was significantly higher in Diclofenac + Thiocolchicoside group as compared to the Diclofenac gel group. Pain relief score for the entire treatment period  and Roland and Morris Disability scoring  were significantly higher in the Diclofenac + Thiocolchicoside group as compared to Diclofenac gel group. Both physicians and patient global assessment were favorable towards Diclofenac + Thiocolchicoside group as compared to Diclofenac gel group. Thus it can be concluded that Topical solution of Diclofenac + thiocolchicoside is more effective as compared to Diclofenac Topical gel in the management of acute nonspecific low back pain. No adverse event was reported among both the treatrment groups  and both the treatment were found safe.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-18
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Male of Female patients aged 18-60 years 2.
• Non specific low back pain with an acute episode of recent onset(less than 48 hours) defined by average pain within the last 24 hours equal or more than 5 on the Visual Analogue Scale (VAS) 3.
• Low back pain of diagnostic category 1( low back pain radiating no farther than the intergluteal fold) or 2 ( low back pain radiating no farther than the knee) as defined by the International Paris Task Force on Back Pain 4.
• Patients who are willing to take medications as directed, to come for follow ups, to give written consent and comply with the protocol requirements.

Exclusion Criteria

• Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination)such as neoplasm, infection or inflammatory disorders.
• Low back pain of diagnostic category 3( low back pain radiating beyond the knee with no neurologic signs)or 4( low back pain radiating to a precise and entire leg dermatome with or without neurologic signs) as defined by the International Paris Task Force on Back pain.
• History of Inflammatory arthritis of Large Joints, or any structural deformity.
• History of seizure disorder, or any recent history of violent trauma, psychiatric or mental diseases or any widespread neurological symptoms.
• History of malignant tumor.
• Patient who have received other therapy [NSAIDs( including aspirin), muscle relaxant or opioid analgesics, physiotherapy, physical manipulations, invasive intervention, accupuncture therapy] within last 48 hours.
• History of Immunosuppression, HIV or use of immunosuppressive drugs.
• Inclusion in another study in past 6 months or previous inclusion in this study.
• History of alcohol, drug or narcotics abuse.
• Thoracic pain 12.
• Patient systemically unwell or having fever, or unexplained weight loss.
• Clinically significant renal dysfunction/ hepatic dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief with study medication	On Day 3 (telephonic follow up)

Secondary Outcome Measures

Name	Time	Method
1.Analgesic scores.	2.Severity of Pain,Local tenderness, Degree of functional impairement.

Trial Locations

Locations (2)

Department of Orthopaedics; 🇮🇳 Varanasi, UTTAR PRADESH, India

Department of Orthopaedics,; 🇮🇳 Vadodara, GUJARAT, India

Department of Orthopaedics

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Rajiv Jain

Principal investigator

09810144912

docrajivj@gmail.com

Dr Rakesh Singh

Principal investigator

09415085658

singhrksortho@rediffmail.com