Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain
Condition: Unilateral Chronic Shoulder Pain; Bilateral Chronic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Conventional Radiofrequency; Pulsed Dose Radiofrequency; Sham
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade); pulsed dose pulsed radiofrequency,we will set the machine to give 480 pulses each pulse of 45 volts for 20 milliseconds duration with a temperature limit of 42 degree centigrade); will receive puncture for 4 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pulsed; radiofrequency; single-dose; shoulder pain; Pain lasts more than one month; patients referred to the pain clinic from the shoulder clinic; Failed all conservative therapies available