Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain

Low Back Pain Clinical Trial

Official title:

Comparison of Ketoprofen Gel to Placebo in Patients Presented With Mechanical Low Back Pain to the Emergency Department: A Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619695
• Other study ID #: 2015/08
• Status: Recruiting
• Phase: Phase 4
• First received: November 30, 2015
• Last updated: December 1, 2015
• Start date: June 2015
• Est. completion date: January 2016

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• 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:

• 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

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

Intervention

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

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (4)

Lead Sponsor	Collaborator
Akdeniz University	Celal Bayar University, Kocatepe University, Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale at 30 minutes		30 minutes	No
Secondary	Adverse effects		30 minutes	Yes

External Links

•   Pubmed link