Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain

Phase 4

• Conditions: Low Back Pain
• Interventions: Drug: Fastjel

• Registration Number: NCT02619695
• Lead Sponsor: Akdeniz University

Brief Summary

Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.

Detailed Description

Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (NSAID) and paracetamol are used commonly in these patients. However, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. Gel forms of NSAIDs are used commonly in the outpatient clinics and shown to be effective in these patients by a Cochrane meta-analysis. However, there is no data on the effect of gel forms of analgesics in ED. The application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects.

The present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-11
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Study First Posted: 2015-12-02
• Last Update Posted: 2015-12-02
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Mechanical low back pain

Exclusion Criteria

• Under 18 years old
• Over 65 years old
• Pain less than 40 mm in visual analogue scale
• Allergy to the study drug
• Drug or alcohol addiction
• Pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoprofen	Fastjel	Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
Placebo	Fastjel	Placebo arm: placebo gel form of ketoprofen

Primary Outcome Measures

Name	Time	Method
visual analogue scale at 30 minutes	30 minutes

Secondary Outcome Measures

Name	Time	Method
Adverse effects	30 minutes

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey