Osteoarthritis, Osteoarthritis, Hip
Conditions
Brief summary
PENG neurolysis in advanced osteoarthritis of the hip joint.
Detailed description
The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the hip joint.
Interventions
PENG sham block with 20ml 0,9% normal saline
DRUG95% ethanol
PENG neurolysis with 2.5ml of 95% ethanol
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Group 1 - PENG sham block Group 2 - PENG neurolysis 95% ethanol
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study * patients with coxarthrosis or gonarthrosis who failed to achieve satisfactory pain control (NRS\>3) despite the use of NSAIDs, Paracetamol, and co-analgetics * Age of patients: from 18 to 110 years of age. * Caucasian patients can give informed, complete, written consent.
Exclusion criteria
* suspected or diagnosed opioid dependence syndrome * active cancer * dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS score | 7 days after procedure | The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Questionnaire (EQ-5D-5L) | 7 days after procedure | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state |
| neurological deficits | 7 days after procedure | yes/no |
| total opioid consumption | 7 days after procedure | milligrams of oral morphine per day |
Countries
Poland
Outcome results
None listed