Ketoprofen Gel vs Placebo in Low Back Pain

Mechanical Low Back Pain Clinical Trial

Official title:

Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02491879
• Other study ID #: 24924
• Status: Recruiting
• Phase: Phase 4
• First received: July 3, 2015
• Last updated: December 2, 2015
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Akdeniz University
• Contact: Mustafa Serinken, MD
• Phone: 00905052991497
• Email: aserinken[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Description:

Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with. Parenteral analgesic is the most common drugs for the these patients in emergency department. However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients. This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients over 18 and lower 65 years old

• Patients presented with mechanical low-back pain

Exclusion Criteria:

• Pain more than 24 hours

• Pain lower than with a pain score of 40 mm

• Allergy to ketoprofen

• Drug or alcohol addiction

• pregnancy and breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Drug:
• Ketoprofen
2.5% Ketoprofen gel with a 2 g local use

Other:
• Placebo
Placebo gel with a 2 g local use

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (3)

Lead Sponsor	Collaborator
Akdeniz University	Celal Bayar University, Kocatepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Pain reduce will be measured by visual analogue scale score at 30 minutes	30 minutes	No
Secondary	Adverse outcome		30 minutes	Yes