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Trial registered on ANZCTR


Registration number
ACTRN12622001046796p
Ethics application status
Submitted, not yet approved
Date submitted
13/07/2022
Date registered
28/07/2022
Date last updated
28/07/2022
Date data sharing statement initially provided
28/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of pulsed radiofrequency in the management of pain in trapeziometacarpal (TMC) arthritis
Scientific title
Efficacy of pulsed radiofrequency in the management of pain in trapeziometacarpal (TMC) arthritis
Secondary ID [1] 307550 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trapeziometacarpal arthritis 326986 0
Hand functional limitation 326987 0
Condition category
Condition code
Musculoskeletal 324176 324176 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twelve patients suffering from pain due to TMC arthritis will be treated with intra-articular pulsed radiofrequency (PRF); after disinfection of the whole skin of the affected hand and forearm, it will be placed on a table equipped with a sterile cover. After a single injection of local anesthetic at the skin entry site (0.20ml of lidocaine 1%), the needle-probe will be placed by the pain therapist (anesthesiologist) in the TMC joint under fluoroscopy guidance with single shot images to control the position of the probe (total x ray exposure time: approximately 20 seconds); then a stimulation of 2Hz, 42°C, 45V for 7 minutes will be applied. The pulse width will be characterized by a duration of 20 msec followed by a wash-out period of 480 msec silent phase. The treatment will be performed once only in an operating room with adequately shielded walls and the total duration of the procedure will be of approximately 20 minutes. During the procedure, patient vital sign will be monitored: noninvasive blood pressure, heart rate, peripheral oxygen saturation, electrocardiography. After the procedure a sterile medication will be applied at the entry point. Patients will be discharged after one hour observation.
Intervention code [1] 324006 0
Treatment: Devices
Comparator / control treatment
Twelve patients suffering from pain due to TMC arthritis will be treated with intra-articular Sluijter-Teixera Poisson pulsed radiofrequency (STP PRF); STP PRF uses a Poisson distribution of energy delivered by the probe to reduce the heat development. After disinfection of the whole skin of the affected hand and forearm, it will be placed on a table equipped with a sterile cover. After a single injection of local anesthetic at the skin entry site (0.20ml of lidocaine 1%), the needle-probe will be placed by the pain therapist (anesthesiologist) in the TMC joint under fluoroscopy guidance with single shot images to control the position of the probe (total x ray exposure time: approximately 20 seconds); then a stimulation of 2Hz, 42°C, 45V for 7 minutes will be applied. The pulse width will be characterized by a duration of 20 msec followed wash-out period of 480 msec silent phase The treatment will be performed once only in an operating room with adequately shielded walls and the total duration of the procedure will be of approximately 20 minutes. During the procedure, patient vital sign will be monitored: noninvasive blood pressure, heart rate, peripheral oxygen saturation, electrocardiography. After the procedure a sterile medication will be applied at the entry point. Patients will be discharged after one hour observation.
Control group
Active

Outcomes
Primary outcome [1] 331987 0
Pain measured with numeric rating scale (NRS)
Timepoint [1] 331987 0
At 15 days, 1 (primary endpoint), 3, 6, and 12 months after the intervention
Secondary outcome [1] 411818 0
Symptoms and functional status of TMC joint measured with Disabilities of the Arm, Shoulder and Hand (DASH)
Timepoint [1] 411818 0
At 15 days, 1, 3, 6, and 12 months after the intervention
Secondary outcome [2] 411819 0
Opposition of the thumb measured by Kapandji score
Timepoint [2] 411819 0
At 15 days, 1, 3, 6, and 12 months after the intervention
Secondary outcome [3] 411820 0
Patient's satisfaction measured by Patient’s Global Impression of Change (PGIC)
Timepoint [3] 411820 0
At 15 days, 1, 3, 6, and 12 months after the intervention
Secondary outcome [4] 411821 0
Grip strength measured by a dynamometer
Timepoint [4] 411821 0
At 15 days, 1, 3, 6, and 12 months after intervention

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years; Eaton-Glickel classification from I to IV; pain in the TMC for more than 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery at TMC joint; other painful disease of the hand (e.g. carpal tunnel syndrome, de Quervain syndrome, trigger finger); neurodegenerative diseases; psychiatric disorders; patients involved in other studies.

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 randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation will be performed by a random sequence of numbers generated by a computer
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
Data will be first analyzed with Shapiro test to assess the normal distribution. Parametric data will be presented as mean and standard deviation (SD), whereas non parametric data as median and interquartile range (IQR). Statistical analysis will be performed through analysis of variance (ANOVA) for parametric data and Friedman test for non parametric data; ANOVA post hoc analysis will be performed with Tukey test, whereas Friedman post hoc analysis will be performed with Dunn test with Bonferroni correction. Differences will be considered statistically significant when p<0.05.
We determined the sample size assuming alpha=0.05, beta=0.10, and, a standard deviation of 1.1 in order to detect a difference in NRS at 1 month after intervention of 2 point; we estimated a sample size of 8 patients for each of the two groups. We will enroll 12 patients per group, considering a potential 30% drop out rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/11/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 24891 0
Italy
State/province [1] 24891 0

Funding & Sponsors
Funding source category [1] 311823 0
Hospital
Name [1] 311823 0
Azienda Ospedaliera Universitaria -Federico II
Country [1] 311823 0
Italy
Primary sponsor type
Individual
Name
Pasquale Buonanno
Address
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini, 5 80131 Naples
Country
Italy
Secondary sponsor category [1] 313299 0
Individual
Name [1] 313299 0
Francesco Smeraglia
Address [1] 313299 0
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini, 5 80131 Naples
Country [1] 313299 0
Italy

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311267 0
Comitato Etico Federico II-AORN Cardarelli Comitato Etico “Università Federico II-AORN Car
Ethics committee address [1] 311267 0
Ethics committee country [1] 311267 0
Italy
Date submitted for ethics approval [1] 311267 0
11/07/2022
Approval date [1] 311267 0
Ethics approval number [1] 311267 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120510 0
Dr Pasquale Buonanno
Address 120510 0
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini, 5 80131 Naples
Country 120510 0
Italy
Phone 120510 0
+390817462545
Fax 120510 0
+380817464719
Email 120510 0
pasquale.buonanno@unina.it
Contact person for public queries
Name 120511 0
Pasquale Buonanno
Address 120511 0
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini, 5 80131 Naples
Country 120511 0
Italy
Phone 120511 0
+390817462545
Fax 120511 0
+380817464719
Email 120511 0
pasquale.buonanno@unina.it
Contact person for scientific queries
Name 120512 0
Pasquale Buonanno
Address 120512 0
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini, 5 80131 Naples
Country 120512 0
Italy
Phone 120512 0
+390817462545
Fax 120512 0
+380817464719
Email 120512 0
pasquale.buonanno@unina.it

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All the demographic data and the outcomes measured without limitations
When will data be available (start and end dates)?
Data will be available after publication with no end date
Available to whom?
To qualified researchers for scientific purposes
Available for what types of analyses?
For articles to be published in international scientific journal
How or where can data be obtained?
Data can be requested by email to the Principal investigator (Pasquale Buonanno, pasquale.buonanno@unina.it


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.