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Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

Primary Purpose

Unilateral Chronic Shoulder Pain, Bilateral Chronic Shoulder Pain

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Conventional Radiofrequency
Pulsed Dose Radiofrequency
Sham
Sponsored by
Mohamed R El Tahan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Chronic Shoulder Pain focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

group p

sham group

group C

Arm Description

pulse radiofrequency lesioning

Controlled, conventional

Pulse dose radiofrequency

Outcomes

Primary Outcome Measures

Pain
reduction of pain immediately and one ,two, and three month .after procedure

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 20, 2012
Last Updated
March 15, 2015
Sponsor
Mohamed R El Tahan
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1. Study Identification

Unique Protocol Identification Number
NCT01561638
Brief Title
Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain
Official Title
Pulsed Radiofrequency Versus New Technique "Pulsed Dose" in Treatment of Chronic Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed R El Tahan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group p
Arm Type
Active Comparator
Arm Description
pulse radiofrequency lesioning
Arm Title
sham group
Arm Type
Placebo Comparator
Arm Description
Controlled, conventional
Arm Title
group C
Arm Type
Active Comparator
Arm Description
Pulse dose radiofrequency
Intervention Type
Procedure
Intervention Name(s)
Conventional Radiofrequency
Intervention Description
pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade)
Intervention Type
Procedure
Intervention Name(s)
Pulsed Dose Radiofrequency
Intervention Description
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
Intervention Name(s)
Sham
Intervention Description
will receive puncture for 4 minutes
Primary Outcome Measure Information:
Title
Pain
Description
reduction of pain immediately and one ,two, and three month .after procedure
Time Frame
up to 3 months from the procedure
Secondary Outcome Measure Information:
Title
Side effects
Description
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
Time Frame
up to12 weeks after the procedure
Title
Shoulder Symptoms
Description
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.
Time Frame
up to12 weeks from the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

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Pulsed Radiofrequency Versus Pulsed Dose for Shoulder Pain

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