Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

Bilateral Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561638
• Other study ID #: Anesth_MUH_6/2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 20, 2012
• Last updated: March 15, 2015
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Scientific & Ethical Committee, Mansoura Anesthesia Department Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Chronic Shoulder Pain
• Shoulder Pain
• Unilateral Chronic Shoulder Pain

Intervention

Procedure:
• Conventional Radiofrequency
pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade)
• 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)
• Sham
will receive puncture for 4 minutes

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed R El Tahan

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	reduction of pain immediately and one ,two, and three month .after procedure	up to 3 months from the procedure	Yes
Secondary	Side effects	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	up to12 weeks after the procedure	Yes
Secondary	Shoulder Symptoms	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.	up to12 weeks from the procedure	Yes