NCT05022381

Brief Summary

The estimated prevalence of hip joint pain is 7% in men and 10% in women over the age of 45 years.Although physical therapy and weight loss, use of walking aids (such as walking sticks) and analgesic agents are used as conservative treatment methods, these methods usually provide short-term and partial benefits.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain. In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

August 25, 2021

Last Update Submit

August 25, 2021

Conditions

Hip Pain Chronic

Keywords

chronic hip painRadiofrequency thermocoagulationAlgologyfemoral and obturatuar nerve

Outcome Measures

Primary Outcomes (1)

  • Chronic pain level

    For this, the patients' preoperative, 1st month, 3rd month and 6th month VPS (Verbal Pain Score) scores will be checked. A 50% reduction in the verbal pain score will be considered significant.

    1 month,3 month, 6 month

Secondary Outcomes (1)

  • Hip functional capacity

    1month,3 month,6month

Other Outcomes (2)

  • Life Quality

    1month, 3 month,6 month

  • Acute pain

    1 week

Study Arms (1)

Preoperative and Postoperative Pain Level

OTHER

The preoperative pain level, hip function and quality of life of patients who underwent radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerve in chronic hip pain will be compared with the postoperative pain level, hip function and quality of life of these patients.

Procedure: Radiofrequency thermal coagulation of articular branches of femoral and obturator nerves

Interventions

Radiofrequency thermal coagulation of articular branches of femoral and obturator nervesPROCEDURE

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. Patients who do not have any complications after the procedure and who are mobilized are discharged in the 2nd hour.

Preoperative and Postoperative Pain Level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be over 18 years old
  • Written consent has been obtained
  • Those with chronic hip pain for more than 3 weeks

You may not qualify if:

  • Major psychiatric illness
  • The patient has lumbar compression pain or referred pain
  • Patients using anticoagulant agents
  • Patients with infection in the area to be treated
  • Those who are allergic to local anesthetics
  • Those who are allergic to betamethasone
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adnan Menderes University Faculty of Medicine

Aydin, Province, 09000, Turkey (Türkiye)

RECRUITING

Adnan Menderes University Faculty of Medicine

Aydin, Province, 09000, Turkey (Türkiye)

NOT YET RECRUITING

Central Study Contacts

sevilay şimşek karaoglu, Msc

CONTACT

+902564441256sevilaysimsek@yahoo.com

sinem sari, Associate Professor

CONTACT

+902564441256sarisinem@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 26, 2021

Study Start

June 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)