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Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01561638
Enrollment
38
Registered
2012-03-23
Start date
2013-06-30
Completion date
2014-04-30
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Chronic Shoulder Pain, Bilateral Chronic Shoulder Pain

Keywords

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

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.

Interventions

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

PROCEDUREPulsed 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)

PROCEDURESham

will receive puncture for 4 minutes

Sponsors

Mohamed R El Tahan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Painup to 3 months from the procedurereduction of pain immediately and one ,two, and three month .after procedure

Secondary

MeasureTime frameDescription
Side effectsup to12 weeks after the procedureAssessment 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 Symptomsup to12 weeks from the procedurePatient 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026