Patient Reported Outcomes Following Interventional Procedures in Pelvic Pain

NCT05531500 | Unknown

• 1 other identifier: pelvic pain outcome
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators aim from this study, to determine the safety and efficacy of pulsed radiofrequency in the management of pudendal neuralgia, compared to current a standard intervention, which is corticosteroid injection for PN, as part of multidisciplinary pain management.

Conditions

Pudendal Neuralgia

Keywords

Pelvic pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain score value from 1 to 10 reported by each individual patient following inter vention

  6months 1 year after intervention

Study Arms (2)

Injection

OTHER

Injection of local anesthetic and steroid to the diseased nerve

Drug: Injection

Radiofrequency

OTHER

Application of radiofrequency to the diseased nerve

Device: Radiofrequency

Interventions

Injection DRUG

Injection of local anesthetic + steroids

Injection

Radiofrequency DEVICE

Application of radiofrequency on the diseased nerve

Radiofrequency

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic pain\> 6 months
• Patients aged \> 18years
• Patients with unilateral or bilateral regional pelvic pain withpudendal irritation diagnosed by a pain clinician and clinically indicated to undergo pudendal nerve block by a consultant experienced in the field.

You may not qualify if:

• Known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury etc
• Pelvic surgery is expected within 3 months
• Breastfeeding or pregnant women
• Known current pelvic/pelvic organ infection or malignancy (Red flags)
• Concurrent radiotherapy treatment to pelvis
• Allergy/sensitivity to lidocaine anaesthetic or/ and corticosteroids therapy
• Contraindication to receive a Pudendal nerve block eg high risk of bleeding
• Active psychiatric or mental conditions ▪ Other uncontrolled medical condition

Sponsors & Collaborators

• Assiut University: lead

Related Links

• https://link.springer.com/article/10.1007/s11608-006-0064-2
• https://connect.springerpub.com/content/sgrcl/5/3/97.abstract
• https://journals.lww.com/anesthesia-analgesia/FullText/2013/12000/The\_Effectiveness\_of\_Pudendal\_Nerve\_Block\_Versus.21.aspx
• https://www.diva-portal.org/smash/record.jsf?pid=diva2:770659
• https://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-6-177
• https://books.google.com/books?hl=ar\&lr=\&id=FMU0AwAAQBAJ\&oi=fnd\&pg=PP1\&dq=+Chestnut+D,+Polley+L,+TsenL,Wong+C,+eds.+Chestnut%E2%80%99s+obstetric+anesthesia:+Principles+and+practice.\&ots=czX9TVymak\&sig=AVjCTsd6bT3TEKhgQ5BoBIJZuXg

MeSH Terms

Conditions

Pudendal Neuralgia; Pelvic Pain

Interventions

Injections

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Medhat SA Farghaly, master

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhat SA Farghaly, Master

CONTACT

2001095105568; medhatsradwan@aun.edu.eg

Saied M Elsawy, PhD

CONTACT

2001030072161; saeedelsawy17@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia , Intensive care and pain medicine

Model Details: parallel groups of different intervention

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: September 9, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share