Bilateral Chronic Shoulder Pain Clinical Trial
Official title:
Pulsed Radiofrequency Versus New Technique "Pulsed Dose" in Treatment of Chronic Shoulder Pain
The "pulsed dose" RF treatment in various painful disorders may provides better pain relief with longer duration compared to previous Pulsed Radiofrequency (PRF) treatment in similar clinical settings. Also, there would has not been any worrisome complications from the procedures.
Pain scores on visual analog scale (VAS) of 0_10 before and two hours immediately after
radiofrequency lesioning and at 30 , 60, 90 day after procedure. Along with Oxford shoulder
score (OSS) is a 12-item patient-reported specifically designed and developed for assessing
outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of
degenerative conditions such as arthritis and rotator cuff problems. . The reduction in
medications and the number of complications associated with the technique will be assessed.
Diagnostic suprascapular nerve block will done by 1.0 ml of 0.5% bupivacaine under
fluoroscopic guidance using non-ionized dye (iohexol). Pain reduction more than 50% based on
mean VAS assessment for at least three hours consider diagnostic.
Machine used is,(NeuroTherm 1100) RF lesion generator. The standard radiofrequency technique
used, patient in sitting position , non-invasive blood pressure and peripheral oxygen
saturation will monitored with non invasive pulse oxymetry. Vascular peripheral intravenous
routes will opened shoulder region exposed and under complete aseptic technique skin will be
anesthetized with 2.0 ml of 2% lidocaine at puncture site, suprascapular notch was
identified. The landmark to guide the initial entry point was a line drawn along the length
of the scapular spine, bisected with a vertical line from the angle of the scapula. A
radiofrequency needle was introduced through the skin, 2.5 cm along the line of the spine in
the upper outer quadrant, and then guided to the edge of the suprascapular notch by use of
C_arm guide fluoroscopy with the image intensifier (22-gauge, 50-mm needle; 5-mm active tip)
The nerve was located accurately by stimulating at 2 Hz (threshold < 0.5 V). PRF was applied
for 120 seconds 2 or 3 times (NeuroTherm radiofrequency lesion generator) creating a
tingling and paresthesia felt in the dermatomal distribution of the nerve in question. Motor
stimulation (2 HZ). Impedances were checked to ensure a complete electrical circuit and
range from 200 to 400 Ohms, if impedance is > 400 1 ml of 1% lidocaine will be injected.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment