None listed
Conditions
Brief summary
The aim of this follow-on study is to determine if transcutaneous pulsed radiofrequency treatment (PRFT) can reduce shoulder pain and if multiple treatments are better than one. Shoulder pain is third most common musculoskeletal problem in the general population and accounts for 5% of general practitioner musculoskeletal consults. The incidence of shoulder pain is 6.6 to 25 cases per 1000 patients, with a peak incidence in the fourth through sixth decades. Favourable outcomes have been reported from case series of transcutaneous PRFT described in conference proceedings and the literature. Our earlier double blind “active” versus “sham” study of 2 Hz 20ms 80V transcutaneous PRFT(ACTRN12609000146291) reduced knee pain by 30% at 1 month. Transcutaneous PRFT is a painless, non-invasive, non-destructive, needle-free treatment that applies a pulsing electrical field around the target nerve using surface mounted electrodes to ‘stun’ rather than destroy the nerves, rendering the nerve incapable of transmitting pain signals. It is not known how transcutaneous PRFT works, however, it is thought to induce long lasting biochemical changes in the target spinal nerves without disrupting sensation or motor function. Treatment can be repeated if there is a good response to the first transcutaneous PRFT. 50 patients referred to Frankston Hospital for non-stabilisation surgery for shoulder pain will be invited to participate in a double blind randomised placebo controlled (DBRPC) trial of transcutaneous PRFT. Patients with an unstable shoulder or unable to communicate in English or don’t want to participate will be excluded. The outcome will be determined by comparing pre and post transcutaneous PRFT self-report of pain intensity, global satisfaction, medication use and Oxford Shoulder Score questionnaire.
Interventions
Double Blind Randomised Control Trial of a single Active (6x two-minute 10ms 5pps 80V in one treatment session) and a single Inactive (6x two-minute 0V in one treatment session) Transcutaneous Pulse Radiofrequency Treatment For Shoulder Pain in patients awaiting non-stabilisation shoulder surgery that takes about 15 minutes to perform. There is a gap of about 30 seconds between the 6 treatments which is the time to reposition the two topical self-adhesive electrodes. Transcutaneous PRF is a no
Double Blind Randomised Control Trial of a single Active (6x two-minute 10ms 5pps 80V in one treatment session) and a single Inactive (6x two-minute 0V in one treatment session) Transcutaneous Pulse Radiofrequency Treatment For Shoulder Pain in patients awaiting non-stabilisation shoulder surgery that takes about 15 minutes to perform. There is a gap of about 30 seconds between the 6 treatments which is the time to reposition the two topical self-adhesive electrodes. Transcutaneous PRF is a non-invasive, non-destructive, needle-free treatment that applies a precisely targeted pulsing electrical field around the target nerve that ‘stuns’ rather than destroys the nerve and making the nerve incapable of transmitting pain signals. Although it is not known how transcutaneous PRF works, it is thought to induce long lasting biochemical changes in the target spinal nerves without disrupting sensation or motor function. Treatment can be repeated if there was a good response to the first transcutaneous PRF.
Sponsors
Dr Murray Taverner
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Waiting list patients for non-stabilisation shoulder surgery with primary complaint of shoulder pain.
Exclusion criteria
Subject on waiting list for stabilisation shoulder surgery or complaints of ipsilateral neck, arm or hand pain. Subject has terminal cancer, is unable to communicate or refuses to participate
Outcome results
None listed