Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

Phase 1

Completed

• Conditions: Unilateral Chronic Shoulder Pain; Bilateral Chronic Shoulder Pain
• Interventions: Procedure: Pulsed Dose Radiofrequency; Procedure: Conventional Radiofrequency; Procedure: Sham

• Registration Number: NCT01561638
• Lead Sponsor: Mohamed R El Tahan

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.

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Study Start: 2013-06
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-15
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	Pulsed Dose Radiofrequency	Pulse dose radiofrequency
group p	Conventional Radiofrequency	pulse radiofrequency lesioning
sham group	Sham	Controlled, conventional

Primary Outcome Measures

Name	Time	Method
Pain	up to 3 months from the procedure	reduction of pain immediately and one ,two, and three month .after procedure

Secondary Outcome Measures

Name	Time	Method
Side effects	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
Shoulder Symptoms	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.

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, DK, Egypt