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Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain

NCT ID: NCT02619695

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketoprofen

Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.

Group Type EXPERIMENTAL

Fastjel

Intervention Type DRUG

2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.

Placebo

Placebo arm: placebo gel form of ketoprofen

Group Type PLACEBO_COMPARATOR

Fastjel

Intervention Type DRUG

2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.

Interventions

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Fastjel

2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role collaborator

Celal Bayar University

OTHER

Sponsor Role collaborator

Kocatepe University

OTHER

Sponsor Role collaborator

Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mustafa Serinken, Professor

Role: STUDY_DIRECTOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mustafa Serinken, Professor

Role: CONTACT

[email protected]

aysel ozkan

Role: CONTACT

[email protected]

Facility Contacts

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Mustafa Serinken

Role: primary

[email protected]

Aysel Ozkan

Role: backup

[email protected]

References

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Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.

Reference Type BACKGROUND
PMID: 26501533 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/26501533

Pubmed link

Other Identifiers

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2015/08

Identifier Type: -

Identifier Source: org_study_id