Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01561638
First received: March 20, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Unilateral Chronic Shoulder Pain
Bilateral Chronic Shoulder Pain
Procedure: Conventional Radiofrequency
Procedure: Pulsed Dose Radiofrequency
Procedure: Sham
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Radiofrequency Versus New Technique "Pulsed Dose" in Treatment of Chronic Shoulder Pain

Further study details as provided by Mansoura University:

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


Secondary Outcome Measures:
  • Side effects [ Time Frame: up to12 weeks after the procedure ] [ Designated as safety issue: Yes ]
    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

  • Shoulder Symptoms [ Time Frame: up to12 weeks from the procedure ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 38
Study Start Date: June 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561638

Contacts
Contact: Zenat M Eldadamony, M.Sec. +20121524300 salma.galal@yahoo.com

Locations
Egypt
Mansoura University Hospitals Recruiting
Mansoura, DK, Egypt, 050
Contact: Eiad A Ramzy, M.D.    +201005774079    eiadramzy@yahoo.com   
Sponsors and Collaborators
Mohamed R El Tahan
  More Information

No publications provided

Responsible Party: Mohamed R El Tahan, Prof., Mansoura University
ClinicalTrials.gov Identifier: NCT01561638     History of Changes
Other Study ID Numbers: Anesth_MUH_6/2011
Study First Received: March 20, 2012
Last Updated: January 7, 2013
Health Authority: Egypt: Scientific & Ethical Committee, Mansoura Anesthesia Department Board

Keywords provided by Mansoura University:
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

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014