Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unilateral Chronic Shoulder Pain Bilateral Chronic Shoulder Pain |
Procedure: Conventional Radiofrequency Procedure: Pulsed Dose Radiofrequency Procedure: Sham |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Pulsed Radiofrequency Versus New Technique "Pulsed Dose" in Treatment of Chronic Shoulder Pain |
- Pain [ Time Frame: up to 3 months from the procedure ] [ Designated as safety issue: Yes ]reduction of pain immediately and one ,two, and three month .after procedure
- Side effects [ Time Frame: up to12 weeks after the procedure ] [ Designated as safety issue: Yes ]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 [ Time Frame: up to12 weeks from the procedure ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 38 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: group p
pulse radiofrequency lesioning
|
Procedure: Conventional Radiofrequency
pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade)
|
|
Placebo Comparator: sham group
Controlled, conventional
|
Procedure: Sham
will receive puncture for 4 minutes
|
|
Active Comparator: group C
Pulse dose radiofrequency
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Zenat M Eldadamony, M.Sec. | +20121524300 | salma.galal@yahoo.com |
| Egypt | |
| Mansoura University Hospitals | Recruiting |
| Mansoura, DK, Egypt, 050 | |
| Contact: Eiad A Ramzy, M.D. +201005774079 eiadramzy@yahoo.com | |
More Information
No publications provided
| Responsible Party: | Mohamed R El Tahan, Prof., Mansoura University |
| ClinicalTrials.gov Identifier: | NCT01561638 History of Changes |
| Other Study ID Numbers: | Anesth_MUH_6/2011 |
| Study First Received: | March 20, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Egypt: Scientific & Ethical Committee, Mansoura Anesthesia Department Board |
Keywords provided by Mansoura University:
|
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 |
Additional relevant MeSH terms:
|
Shoulder Pain Arthralgia Joint Diseases |
Musculoskeletal Diseases Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013