Ketoprofen Gel vs Placebo in Low Back Pain

Sponsor

Akdeniz University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02491879

Collaborator

Kocatepe University (Other), Celal Bayar University (Other)

100

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mechanical Low Back Pain	Drug: Ketoprofen Other: Placebo	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketoprofen Ketoprofen gel	Drug: Ketoprofen 2.5% Ketoprofen gel with a 2 g local use Other Names: Fastjel
Placebo Comparator: Placebo Placebo form of ketoprofen gel	Other: Placebo Placebo gel with a 2 g local use Other Names: normal saline

Arm

Intervention/Treatment

Experimental: Ketoprofen

Ketoprofen gel

Drug: Ketoprofen

2.5% Ketoprofen gel with a 2 g local use

Other Names:

Fastjel

Placebo Comparator: Placebo

Placebo form of ketoprofen gel

Other: Placebo

Placebo gel with a 2 g local use

Other Names:

normal saline

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale [30 minutes]
Pain reduce will be measured by visual analogue scale score at 30 minutes

Secondary Outcome Measures

Adverse outcome [30 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli		Turkey

Sponsors and Collaborators

Akdeniz University
Kocatepe University
Celal Bayar University

Investigators

Study Chair: Mustafa Serinken, MD, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Akdeniz University

ClinicalTrials.gov Identifier:

NCT02491879

Other Study ID Numbers:

24924

First Posted:

Jul 8, 2015

Last Update Posted:

Dec 3, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Akdeniz University

mechanical low back pain

emergency department

ketoprofen

gel

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Ketoprofen

Study Results

No Results Posted as of Dec 3, 2015