None listed
Conditions
Brief summary
TMC osteoarthritis has a prevalence of 10% and the subsequent pain can cause discomfort and functional limitations which deeply impact everyday life. Radiological images are fundamental to define the stage of the disease which is usually assesed by Eaton-Glickel classification. Conservative treatment is not generally effective and the effectiveness of surgical approach is not yet clearly defined. Intra-articular pulsed radiofrequency may be considered to manage pain in TMC osteoarthritis: it uses electrical energy to modulate the transmission of pain signal through the nerves. Classic PRF is characterized by fixed parameters of the stimulation; STP-PRF is a novel approach to PRF characterized by a variation of energy delivered according to a Poissson distribution thus limiting the development of heat. The aim of our study is to assess the effectiveness of PRF in the management of pain due to TMC osteoarthritis and to compare PRF and STP-PRF. Our hypothesis is that PRF, which has proved to efficiently relieve other joint pains, can be similarly effective in the management of TMC osteoarthritis; furthermore, we hypothesize that STP-PRF could be superior to classical PRF.
Interventions
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
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.
Sponsors
Pasquale Buonanno
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed