Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

NCT ID: NCT01561638

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Unilateral Chronic Shoulder Pain; Bilateral Chronic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group p

pulse radiofrequency lesioning

Group Type: ACTIVE_COMPARATOR

Conventional Radiofrequency

Intervention Type: PROCEDURE

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

sham group

Controlled, conventional

Group Type: PLACEBO_COMPARATOR

Sham

Intervention Type: PROCEDURE

will receive puncture for 4 minutes

group C

Pulse dose radiofrequency

Group Type: ACTIVE_COMPARATOR

Pulsed Dose Radiofrequency

Intervention Type: 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)

Interventions

Conventional Radiofrequency

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

Intervention Type: 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)

Intervention Type: PROCEDURE

Sham

will receive puncture for 4 minutes

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamed R El Tahan

OTHER

Sponsor Role: lead

Responsible Party

Mohamed R El Tahan

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mansoura University Hospitals

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

Anesth_MUH_6/2011

Identifier Type: -

Identifier Source: org_study_id