Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01561638
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University

Brief 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.

Condition or disease Intervention/treatment Phase
Unilateral Chronic Shoulder Pain Bilateral Chronic Shoulder Pain Procedure: Conventional Radiofrequency Procedure: Pulsed Dose Radiofrequency Procedure: Sham Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Radiofrequency Versus New Technique "Pulsed Dose" in Treatment of Chronic Shoulder Pain
Study Start Date : June 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Active Comparator: group p
pulse radiofrequency lesioning
Procedure: Conventional Radiofrequency
pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade)

Placebo Comparator: sham group
Controlled, conventional
Procedure: Sham
will receive puncture for 4 minutes

Active Comparator: group C
Pulse dose radiofrequency
Procedure: Pulsed Dose Radiofrequency
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)

Primary Outcome Measures :
  1. Pain [ Time Frame: up to 3 months from the procedure ]
    reduction of pain immediately and one ,two, and three month .after procedure

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01561638

Mansoura University Hospitals
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mohamed R El Tahan

Responsible Party: Mohamed R El Tahan, Prof., Mansoura University Identifier: NCT01561638     History of Changes
Other Study ID Numbers: Anesth_MUH_6/2011
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Mohamed R El Tahan, Mansoura University:
shoulder pain
Pain lasts more than one month
patients referred to the pain clinic from the shoulder clinic
Failed all conservative therapies available

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms