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Trial registered on ANZCTR


Registration number
ACTRN12613001074785
Ethics application status
Not yet submitted
Date submitted
23/09/2013
Date registered
25/09/2013
Date last updated
25/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Using oral broad-spectrum antibiotics as an adjuvant therapy in conservative management of lumbar disc hernia; a clinical trial
Scientific title
The effect of ciprofloxacin/co-amoxiclav administration during conservative management of patients with herniated lumbar disc on pain severity and patient's satisfaction
Secondary ID [1] 283287 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar disc hernia 290170 0
Condition category
Condition code
Neurological 290556 290556 0 0
Other neurological disorders
Musculoskeletal 290557 290557 0 0
Other muscular and skeletal disorders
Anaesthesiology 290564 290564 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
at least 90 patients with lumbar disc hernia who are candidates of conservative (nonsurgical) treatment will be randomized in three 30-patient, age- and sex-matched groups. Management will be similar in all three groups. One group will receive oral ciprofloxacin, 500mg twice daily for 2 weeks. Another group will receive oral co-amoxical 250 mg three time daily for 2 weeks. In the third group no antibiotic will be administered.
Intervention code [1] 288012 0
Treatment: Drugs
Comparator / control treatment
Only standard management including advice to rest and stay inactive for at least 2 weeks, as well as conservative (nonsurgical) treatments such as analgesics and anti-inflammatories.
This is the group that will not be administered any antibiotics.
Control group
Active

Outcomes
Primary outcome [1] 290580 0
Pain score according to visual analogue scale (VAS)
Timepoint [1] 290580 0
days 0, 14, 28, 48, 56 and month 3
Secondary outcome [1] 304838 0
SF-36 score (functional health and well-being sections)
Timepoint [1] 304838 0
days 0, 14, 28, 48, 56 and month 3
Secondary outcome [2] 304839 0
Oswery Disability Index
Timepoint [2] 304839 0
days 0, 14, 28, 48, 56 and month 3
Secondary outcome [3] 304840 0
Patient's satisfaction rate using a likert scale system:
5=Very satisfied, 4=Satisfied, 3=Neutral, 2=Dissatisfied, 1-Very dissatisfied.
Timepoint [3] 304840 0
month 3
Secondary outcome [4] 304841 0
The level of serum C-reactive protein(CRP) using the enzyme-linked immunosorbent assay (ELISA) and erythrocyte sedimentation rate (ESR) using the Westergren method
Timepoint [4] 304841 0
day 0 and month 3

Eligibility
Key inclusion criteria
Patients with lumbar disc hernia who are candidates for conservative (nonsurgical) treatment with symptoms present for >6 months
Minimum age
40 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates of surgical treatment, those with active infection, and patients with previous spinal surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers will be used for consecutive attending patients at department of neurosurgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The Chi-sqaure or Fisher's Exact test for categorical data; One-way ANOVA with Tukey post hoc analysis or the Kruskal-Wallis test with an appropriate post hoc analysis for numerical data based on their distribution.
To detect a pain relief=1.5 units according to VAS, with a standard deviation=2 (according to previous reports), at a significant level of 5% (a two-sided t-test) with 80% power 27 patients were needed in each group, which was augmented to 30.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5438 0
Iran, Islamic Republic Of
State/province [1] 5438 0
West Azarbayjan

Funding & Sponsors
Funding source category [1] 288027 0
Self funded/Unfunded
Name [1] 288027 0
Daniel F Fouladi
Address [1] 288027 0
Daneshgah Street, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Country [1] 288027 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Daniel F Fouladi
Address
Daneshgah Street, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286744 0
None
Name [1] 286744 0
Address [1] 286744 0
Country [1] 286744 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289951 0
Urmia University of Medical Sciences
Ethics committee address [1] 289951 0
Jahad Ave., Urmia University of Medical Sciences, urmia
Ethics committee country [1] 289951 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 289951 0
30/09/2013
Approval date [1] 289951 0
Ethics approval number [1] 289951 0

Summary
Brief summary
According to results of some recent studies, infection may cause Modic changes. This study aims to investigate whether antibiotic therapy along with conventional management of non-surgical lumbar disc herniation may cause better and/or rapid amelioration of symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43226 0
Dr Daniel F Fouladi
Address 43226 0
Daneshgah Street, Pashmineh Building, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Country 43226 0
Iran, Islamic Republic Of
Phone 43226 0
+989144122542
Fax 43226 0
Email 43226 0
medicorelax@yahoo.com
Contact person for public queries
Name 43227 0
Dr Daniel F Fouladi
Address 43227 0
Daneshgah Street, Pashmineh Building, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Country 43227 0
Iran, Islamic Republic Of
Phone 43227 0
+989144122542
Fax 43227 0
Email 43227 0
medicorelax@yahoo.com
Contact person for scientific queries
Name 43228 0
Dr Daniel F Fouladi
Address 43228 0
Daneshgah Street, Pashmineh Building, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz
Country 43228 0
Iran, Islamic Republic Of
Phone 43228 0
+989144122542
Fax 43228 0
Email 43228 0
medicorelax@yahoo.com

No data has been provided for results reporting
Summary results
Not applicable