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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05822310
Other study ID # 2022/07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date April 1, 2024

Study information

Verified date April 2023
Source Aydin Adnan Menderes University
Contact BILGENUR ERGÜN DEMIRÖZ, RESIDENT DOCTOR
Phone +902564441256
Email bilgenurergunn@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study ,the investigators aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent chronic hip painRFT , intraartıcular steroid injection and Peng block.


Description:

Hip pain is a common medical condition with increasing age.The effectiveness of conservative methods used in hip pain is limited.Since the lifespan of prostheses used in hip surgery is limited, new methods are needed in the treatment of pain.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Today, the most commonly used techniques for hip pain are corticosteroid administration into the hip joint, pericapsular nerve group (PENG) block application, and radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves. The aim of this study is to compare the effects of these three procedures in hip pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. be over 18 years old 2. Written consent has been obtained 3. Those with chronic hip pain for more than 3 weeks Exclusion Criteria: 1. Major psychiatric illness 2. The patient has lumbar compression pain or referred pain 3. Patients using anticoagulant agents 4. Patients with infection in the area to be treated 5. Those who are allergic to local anesthetics 6. Those who are allergic to betamethasone 7. Pregnancy 8. Patients who underwent hip surgery during the 3-month follow-up period during the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves
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.
intraairticular steroid injection
The patients were placed in the supine position in the operating room. The patient was stained sterile with povidone iodide. The femoral neck was detected under ultrasonography and the joint capsule was entered with a 22G 9 cm spinal needle. Then, 5 cc bupivacaine and 5 mg betamethasone were given and the procedure was terminated.
pericapsular nerve group (PENG) block
The patients were placed in the supine position in the operating room. The patient was stained sterile with povidone iodide. The high-frequency linear ultrasonography probe was placed on the anterior superior iliacspina (ASIS). Later, the anterior inferior iliac spine (AIIS) was detected by descending caudally. Afterwards, the probe was brought to the oblique position and AIIS, iliopubikeminence, psoas muscle and tendon were seen. Using a 22G 90-mm Quinckespinal needle, the tendon of the iliopsoas muscle was entered in the lateral-medial direction in the in-plane plane and bone contact was achieved. After negative aspiration, 15 ml of 0.5% bupivacaine were administered by seeing the appropriate drug distribution.

Locations

Country Name City State
Turkey Adnan Menderes University Faculty of Medicine Aydin

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other NRS(Numerating Rating Scale) for acute pain It is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain postoperative second hour
Primary NRS(Numerating Rating Scale) for chronic pain It is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain preoperative
Primary NRS(Numerating Rating Scale) for chronic pain It is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain Postoperative first month
Primary NRS(Numerating Rating Scale) for chronic pain It is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain Postoperative third month
Secondary WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex ) It includes 24 questions under three sub-headings as pain, stiffness and physical function. Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe.minimum score is 0=good maximum score is 96 = bad functional capacity Preoperative
Secondary WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex ) It includes 24 questions under three sub-headings as pain, stiffness and physical function. Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe.minimum score is 0=good maximum score is 96 = bad functional capacity Postoperative first month
Secondary WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex ) It includes 24 questions under three sub-headings as pain, stiffness and physical function. Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe.minimum score is 0=good maximum score is 96 = bad functional capacity Postoperative third month
See also
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Completed NCT02479828 - Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients N/A
Withdrawn NCT02861170 - Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability N/A
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