ClinicalTrials.Veeva

Menu

Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

M

Mohamed R El Tahan

Status and phase

Completed
Phase 2
Phase 1

Conditions

Unilateral Chronic Shoulder Pain
Bilateral Chronic Shoulder Pain

Treatments

Procedure: Conventional Radiofrequency
Procedure: Pulsed Dose Radiofrequency
Procedure: Sham

Study type

Interventional

Funder types

Other

Identifiers

NCT01561638
Anesth_MUH_6/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 3 patient groups, including a placebo group

group p
Active Comparator group
Description:
pulse radiofrequency lesioning
Treatment:
Procedure: Conventional Radiofrequency
sham group
Placebo Comparator group
Description:
Controlled, conventional
Treatment:
Procedure: Sham
group C
Active Comparator group
Description:
Pulse dose radiofrequency
Treatment:
Procedure: Pulsed Dose Radiofrequency

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems