"Comparison of the Effectiveness of Conventional Radiofrequency Thermocoagulation and Chemical Ablation With Phenol on Articular Branches of Femoral and Obturator Nerves in Chronic Hip Pain"

NCT06570746 | Not Yet Recruiting

• 1 other identifier: 2024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

"In our study, we aimed to compare the effects of conventional radiofrequency thermocoagulation applied to the articular branches of the femoral and obturator nerves with chemical ablation using phenol on hip pain."

Conditions

Chronic Pain

Keywords

Radiofrequency thermocoagulation; Phenol chemical ablation

Outcome Measures

Primary Outcomes (3)

• NRS (Numerical Rating Scale)

  We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant

  preoperative

• NRS (Numerical Rating Scale)

  We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant

  postoperative first month

• NRS (Numerical Rating Scale)

  We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant

  postoperative third month

Secondary Outcomes (3)

• WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )

  preoperative

• WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )

  postoperative first month

• WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )

  postoperative third month

Study Arms (2)

radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves

EXPERIMENTAL

Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points.

Drug: Sedative

Chemical ablation with phenol

ACTIVE COMPARATOR

Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points. Before the procedure, the femoral artery was visualized with a linear ultrasound probe to prevent arterial injury by entering 2 cm lateral to the femoral artery. Following this, a mixture of 2.5 cc of 0.05% bupivacaine and 2.5 cc of 6% phenol was applied, and a lesion was created for 90 seconds at 80°.

Drug: Sedative

Interventions

Sedative DRUG

Sedation is applied before the procedure

Chemical ablation with phenol; radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves

Eligibility Criteria

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

You may qualify if:

• Be older than 18 years old. Written consent must be obtained. Have had chronic hip pain for more than 3 weeks. -

You may not qualify if:

• Major psychiatric illness Presence of lumbar radicular pain or referred pain in the patient Patients using anticoagulant agents Patients with infection in the area where the procedure will be performed Those with allergy to local anesthetics Those allergic to phenol or betamethasone Pregnant women Scheduled for surgery

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Faculty of Medicine

Aydin, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Hypnotics and Sedatives

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• akylai dosieva

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akylai Dosieva, Resident doctor

CONTACT

+905365088993; akylaidosieva@mail.ru

osman nuri aydın, Professor

CONTACT

905325125124; onaydin@superonline.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: May 25, 2025
• Study Completion: June 25, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

TU (1)