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Completed

NCT Number: NCT01561638

Pulsed Radiofrequency Versus Pulsed Dose for 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged at least 18 years old
  • both male and female
  • had unilateral or bilateral chronic shoulder pain longer than one month
  • rotator cuff tear arthropathy
  • adhesive capsulitis shoulder instability
  • post-traumatic pain
  • post-surgical pain

Exclusion criteria

  • Duration of shoulder pain < 1 month
  • Patients had any previous surgical intervention or nerve blocks to the shoulder.
  • patient refused or declined treatment
  • Allergy to local anesthetics or steroid or contrast material.
  • Severe psychiatric illness disorder,
  • infection at site of injection
  • Patients with a pacemaker or neurostimulator.
  • Pregnancy.

Treatment and study plan

Conventional Radiofrequency

Procedure

pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade)

Pulsed Dose Radiofrequency

Procedure

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)

Sham

Procedure

will receive puncture for 4 minutes

Primary outcomes

  1. Pain

    Time frame: up to 3 months from the procedure

    reduction of pain immediately and one ,two, and three month .after procedure

Secondary outcomes

  1. Side effects

    Time frame: up to12 weeks after the procedure

    Assessment of short term side effects and persisting side effects such as nausea, headache, momentary increase in pain, fever, tingling, itching, chest pain and/or burning skin at point of treatment

  2. Shoulder Symptoms

    Time frame: up to12 weeks from the procedure

    Patient Self-Assessment of Shoulder Symptoms Before and After procedure Subjective symptoms would be recorded before procedure, and two hours after procedure, at four weeks, eight weeks, and twelve weeks.

Sponsors and collaborators

Lead sponsor

Mohamed R El Tahan

Other

Registry information

Official study title

Pulsed Radiofrequency Versus New Technique "Pulsed Dose" in Treatment of Chronic Shoulder Pain

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2012
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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