NCT06034418

Brief Summary

Our aim in this interventional study is to investigate the effectiveness of pulsed radiofrequency (PRF) treatment applied to the articular branches of the femoral and obturator nerves on pain, functional level, functional capacity and quality of life in patients with coxarthrosis. We will compare the effects of PRF treatment added to nerve block compared to nerve block alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

November 25, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

August 22, 2023

Last Update Submit

February 6, 2024

Conditions

Coxarthrosis; Primary

Keywords

coxarthrosispainpulse radiofrequencynerve block

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) is one of the pain rating scales. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (extreme pain). At rest, with movement, nighttime VAS scores and averages of them will be recorded.

    baseline, week 2, week 4 and week 12

Secondary Outcomes (6)

  • Active Range of Motion

    baseline, week 2, week 4 and week 12

  • Passive Range of Motion

    baseline, week 2, week 4 and week 12

  • Harris Hip Score (HHS)

    baseline, week 2, week 4 and week 12

  • Six Minute Walk Test

    baseline, week 2, week 4 and week 12

  • Short From-36 (SF-36)

    baseline, week 2, week 4 and week 12

  • +1 more secondary outcomes

Study Arms (2)

Pulse Radiofrequency Group

ACTIVE COMPARATOR

Pulse radiofrequency therapy will be applied to each nerve in 2 cycles of 120 seconds for patients in the pulse radiofrequency group. After the pulse radiofrequency procedure, 1 cc betamethasone and 1 cc 1% lidocaine will be injected for each nerve.

Device: Pulse radiofrequency treatmentDrug: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine

Block Group

ACTIVE COMPARATOR

For the patients in the block group, nerve block will be performed by applying 1 cc betamethasone and 1 cc 1% lidocaine for each nerve.

Drug: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine

Interventions

Pulse radiofrequency treatmentDEVICE

In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, pulse radiofrequency will be applied to each nerve in 2 cycles of 120 seconds for the patients in this group. The pulse radiofrequency current will be 20 milliseconds wide and 45 volts in size. The tip temperature shall not be more than 42℃.

Pulse Radiofrequency Group
Nerve block with 1 cc betamethasone and 1 cc 1% lidocaineDRUG

In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, patients will be injected with 1 cc betamethasone and 1 cc 1% lidocaine for each nerve. A total of 2 cc volume will be injected for each nerve.

Block GroupPulse Radiofrequency Group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unilateral and/or bilateral hip pain for more than 6 months who meet the diagnosis of coxarthrosis according to the American College of Rheumatology(ACR) criteria
  • Pain intensity greater than 3 according to the visual analog pain scale
  • Stage ≥2 hip osteoarthritis according to the Kellgren-Lawrence classification
  • Ambulation with or without support
  • Having the mental competence to express pain scores
  • Signing an informed consent form stating consent to participate in the study

You may not qualify if:

  • Other non-degenerative causes of hip pain (Avascular necrosis, femoraacetebular impingement syndrome, thoracenteric bursitis)
  • Concomitant central nervous system and/or peripheral nervous system disease
  • History of lower extremity fracture/surgery in the last 6 months
  • Local infection on the hip or presence of systemic infection
  • Conditions where fluoroscopy-guided injection is contraindicated like pregnancy, contrast material allergy, local anesthetic allergy, coagulopathy
  • Presence of unstable systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, HipPain

Interventions

Nerve BlockLidocaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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
MD

Study Record Dates

First Submitted

August 22, 2023

First Posted

September 13, 2023

Study Start

November 25, 2022

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)