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Ketoprofen Gel vs Placebo in Low Back Pain

Primary Purpose

Mechanical Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ketoprofen
Placebo
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring mechanical low back pain, emergency department, ketoprofen, gel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketoprofen

Placebo

Arm Description

Ketoprofen gel

Placebo form of ketoprofen gel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse outcome

Full Information

First Posted
July 3, 2015
Last Updated
December 2, 2015
Sponsor
Akdeniz University
Collaborators
Kocatepe University, Celal Bayar University
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1. Study Identification

Unique Protocol Identification Number
NCT02491879
Brief Title
Ketoprofen Gel vs Placebo in Low Back Pain
Official Title
Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University
Collaborators
Kocatepe University, Celal Bayar University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
mechanical low back pain, emergency department, ketoprofen, gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketoprofen
Arm Type
Experimental
Arm Description
Ketoprofen gel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo form of ketoprofen gel
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Other Intervention Name(s)
Fastjel
Intervention Description
2.5% Ketoprofen gel with a 2 g local use
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline
Intervention Description
Placebo gel with a 2 g local use
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Pain reduce will be measured by visual analogue scale score at 30 minutes
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Adverse outcome
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Serinken, MD
Phone
00905052991497
Email
aserinken@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cenker Eken, MD
Phone
00905321593948
Email
cenkereken@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, MD
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysel Özkan
Phone
00902582961758
Email
karek@pau.edu.tr

12. IPD Sharing Statement

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Ketoprofen Gel vs Placebo in Low Back Pain

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