Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000149662
Ethics application status
Approved
Date submitted
28/01/2014
Date registered
7/02/2014
Date last updated
7/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of intraarticular pulsed radiofrequency to intraarticular plus saphenous nerve pulsed radiofrequency in gonarthrosis
Scientific title
Effect of intraarticular pulsed radiofrequency versus intraarticular + saphenous nerve pulsed radiofrequency on WOMAC scores in patients with grade 2-3 gonarthrosis
Secondary ID [1] 283991 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gonarthrosis 291026 0
Condition category
Condition code
Musculoskeletal 291367 291367 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intraarticular pulsed mode radiofrequency

administered for 10 minutes with 2 hz 50 volt , 1 session
Intervention code [1] 288679 0
Rehabilitation
Intervention code [2] 288680 0
Treatment: Devices
Comparator / control treatment
intraarticular + saphenous nerve pulsed radiofrequency

administered for 10 minutes (intraarticular) + administered for 2 minutes (saphenous nerve) with 2 hz 50 volt , 1 session
Control group
Active

Outcomes
Primary outcome [1] 291365 0
Mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) for pain, stiffness and functional limitation
Timepoint [1] 291365 0
Baseline, 2. month and 4. month after intervention
Secondary outcome [1] 306601 0
nil
Timepoint [1] 306601 0
nil

Eligibility
Key inclusion criteria
diagnosed with primary knee osteoarthritis
grade 2-3 Kellgren & Lawrence gonarthrosis
suffering from knee pain at least 6 months period
no any other reason for knee pain
under oral analgesic medication but stopped 2 days before intervention
no contraindication for knee injection
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
haematologic problems, local or systemic infection, morbid obese patient )BMI>40), physiatric patient, surgical candidate for gonarthrosis, local anesthetic sensitivity

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)
central randomisation by computer
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
post-hoc power analysis with power 0.95 and alpha
equal to 0.05, 30 patients per group enrolled.
Normality was tested with the Kolmogorov–Smirnov z-test. Student’s t-test was used to compare parametric variables, the Mann–Whitney U-test for non-parametric variables.
Categorical analyses between two independent groups with Chi Square test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2012
Actual
5/01/2012
Date of last participant enrolment
Anticipated
26/04/2012
Actual
26/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5787 0
Turkey
State/province [1] 5787 0

Funding & Sponsors
Funding source category [1] 288617 0
Hospital
Name [1] 288617 0
Istanbul Egitim ve Arastirma Hastanesi, Agri Klinigi
(Istanbul Research and Training Hospital, Pain Management Clinic)
Country [1] 288617 0
Turkey
Primary sponsor type
Individual
Name
Dr. Onat Akyol
Address
Dolapdere caddesi 193/3 pangalti sisli 34375 Istanbul

Istanbul Kartal Egitrim ve Arastirma Hastanesi
Country
Turkey
Secondary sponsor category [1] 287327 0
None
Name [1] 287327 0
Address [1] 287327 0
Country [1] 287327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290477 0
Istanbul Egitim ve Arastirma Hastanesi Yerel Etik Kurulu
Ethics committee address [1] 290477 0
org. abdurrahman nafiz gurman caddesi 34098 samatya fatih Istanbul
Ethics committee country [1] 290477 0
Turkey
Date submitted for ethics approval [1] 290477 0
Approval date [1] 290477 0
16/11/2011
Ethics approval number [1] 290477 0

Summary
Brief summary
intraarticular and saphenous nerve pulsed radiofrequency treatment for gonarthrosis in means of pain, stiffness and functional limitation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45878 0
Dr Onat Akyol
Address 45878 0
Dolapdere caddesi 193/3 pangalti sisli 34375 Istanbul

Istanbul Kartal Egitim ve Arastirma Hastanesi
Country 45878 0
Turkey
Phone 45878 0
+90 5327619680
Fax 45878 0
Email 45878 0
onatakyol@hotmail.com
Contact person for public queries
Name 45879 0
Dr Onat Akyol
Address 45879 0
Dolapdere caddesi 193/3 pangalti sisli 34375 Istanbul

Istanbul Kartal Egitim ve Arastirma Hastanesi
Country 45879 0
Turkey
Phone 45879 0
+90 5327619680
Fax 45879 0
Email 45879 0
onatakyol@hotmail.com
Contact person for scientific queries
Name 45880 0
Dr Onat Akyol
Address 45880 0
Dolapdere caddesi 193/3 pangalti sisli 34375 Istanbul

Istanbul Kartal Egitim ve Arastirma Hastanesi
Country 45880 0
Turkey
Phone 45880 0
+90 5327619680
Fax 45880 0
Email 45880 0
onatakyol@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.