NCT03456531

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 7, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

February 24, 2018

Last Update Submit

March 4, 2018

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • pain measure

    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

    1 week

Secondary Outcomes (1)

  • Range of motion of the shoulder

    3 months

Study Arms (2)

group 1

ACTIVE COMPARATOR

20 patients will receive pulsed radiofrequency for 6 minutes to suprascapular nerve

Device: pulsed radiofrequency

group 2

PLACEBO COMPARATOR

20 patients will receive their medical treatment in the form of NSAIDs "ibubrofen,Aspirin"

Drug: NSAIDs "ibubrofen,Aspirin"

Interventions

pulsed radiofrequencyDEVICE

The patient will have pulsed radiofrequency to suprascapular nerve for 6 minutes

Also known as: PRF
group 1
NSAIDs "ibubrofen,Aspirin"DRUG

medical treatment as NSAIDs "ibubrofen,Aspirin"

Also known as: Analgesics
group 2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Liliang PC, Lu K, Liang CL, Tsai YD, Hsieh CH, Chen HJ. Pulsed radiofrequency lesioning of the suprascapular nerve for chronic shoulder pain: a preliminary report. Pain Med. 2009 Jan;10(1):70-5. doi: 10.1111/j.1526-4637.2008.00543.x.

    PMID: 19222771BACKGROUND

  • Jang JS, Choi HJ, Kang SH, Yang JS, Lee JJ, Hwang SM. Effect of pulsed radiofrequency neuromodulation on clinical improvements in the patients of chronic intractable shoulder pain. J Korean Neurosurg Soc. 2013 Dec;54(6):507-10. doi: 10.3340/jkns.2013.54.6.507. Epub 2013 Dec 31.

    PMID: 24527194BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Pulsed Radiofrequency TreatmentAspirinAnalgesics

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRadiofrequency TherapyRehabilitationSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • ayman othman, proffessor

    Assiut univerisity

    STUDY DIRECTOR

Central Study Contacts

yasmeen elmasry, RD

CONTACT

01093910848yasmeen1992.ye@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized clinically controlled study .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

February 24, 2018

First Posted

March 7, 2018

Study Start

March 15, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

March 7, 2018

Record last verified: 2018-02