NCT01561638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

March 20, 2012

Last Update Submit

March 15, 2015

Conditions

Unilateral Chronic Shoulder PainBilateral Chronic Shoulder Pain

Keywords

Pulsedradiofrequencysingle-doseshoulder painPain lasts more than one monthpatients referred to the pain clinic from the shoulder clinicFailed all conservative therapies available

Outcome Measures

Primary Outcomes (1)

  • Pain

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

    up to 3 months from the procedure

Secondary Outcomes (2)

  • Side effects

    up to12 weeks after the procedure

  • Shoulder Symptoms

    up to12 weeks from the procedure

Study Arms (3)

group p

ACTIVE COMPARATOR

pulse radiofrequency lesioning

Procedure: Conventional Radiofrequency

sham group

PLACEBO COMPARATOR

Controlled, conventional

Procedure: Sham

group C

ACTIVE COMPARATOR

Pulse dose radiofrequency

Procedure: Pulsed Dose Radiofrequency

Interventions

Conventional RadiofrequencyPROCEDURE

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

group p
Pulsed Dose RadiofrequencyPROCEDURE

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)

group C
ShamPROCEDURE

will receive puncture for 4 minutes

sham group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 23, 2012

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

EG(1)