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Pulsed Radiofrequency for Frozen Shoulder Chronic Pain (PRFFSCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03456531
Recruitment Status : Unknown
Verified February 2018 by Yasmeen alaa-eldeen elmasry, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Yasmeen alaa-eldeen elmasry, Assiut University

Brief Summary:
this study to detect the effect of pulsed radiofrequency to the suprascapular nerve in treating chronic pain and to evaluate range of motion of shoulder joint after the intervention

Condition or disease Intervention/treatment Phase
Frozen Shoulder Device: pulsed radiofrequency Drug: NSAIDs "ibubrofen,Aspirin" Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized clinically controlled study .
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pulsed Radiofrequency to the Suprascapular Nerve in Treating Frozen Shoulder Pain
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: group 1
20 patients will receive pulsed radiofrequency for 6 minutes to suprascapular nerve
Device: pulsed radiofrequency
The patient will have pulsed radiofrequency to suprascapular nerve for 6 minutes
Other Name: PRF

Placebo Comparator: group 2
20 patients will receive their medical treatment in the form of NSAIDs "ibubrofen,Aspirin"
Drug: NSAIDs "ibubrofen,Aspirin"
medical treatment as NSAIDs "ibubrofen,Aspirin"
Other Name: Analgesics

Primary Outcome Measures :
  1. pain measure [ Time Frame: 1 week ]
    to evaluate the efficacy of pulsed radiofrequency lesioning to the suprascapular nerve in treating pain in frozen shoulder using numeric pain rating scale where 0 is no pain and 10 is the worst pain ever

Secondary Outcome Measures :
  1. Range of motion of the shoulder [ Time Frame: 3 months ]
    evaluate patient range of motion after the intervention using the simple shoulder test "by answering 12 questions "

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients who are complaining of chronic pain due to frozen shoulder for more than 3 weeks.
  • All of them will be above 30 years and from areas nearby our hospital to make the follow up easy and complete.
  • All participants will be ASA physical status I-III and random blood glucose will be measured 1 week before intervention.

Exclusion Criteria:

  • Those with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in targeted region, those with history of chronic opioid use and those who refused to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03456531

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Contact: yasmeen elmasry, RD 01093910848

Sponsors and Collaborators
Assiut University
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Study Director: ayman othman, proffessor Assiut univerisity
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Responsible Party: Yasmeen alaa-eldeen elmasry, resident doctor, Assiut University Identifier: NCT03456531    
Other Study ID Numbers: SSN PRF
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors