Knee Pain ChronicNCT06060678
Efficacy of Genicular Nerve Alcohol Neurolysis in Knee Osteoarthritis Pain
An observational study of Knee Pain Chronic, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the Western Ontario and McMaster Universities… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Pain Chronic
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2023to 5 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients who underwent genicular nerve alcohol neurolysis for knee osteoarthritis pain
Who may be able to join
- Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
- Permanent pain for more than 6 months
- Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
- Pain with conservative methods such as analgesics and physiotherapy treatment failure
Who cannot join
- History of intra-articular knee intervention in the last 6 months
- Cognitive impairment
- Hepatic or renal insufficiency
- Severe psychiatric illness
- Local or systemic infection
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Genicular Nerve Alcohol Neurolysis in the Management of Knee Osteoarthritis Pain
This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). NRS and WOMAC scores will be evaluated before, 1, and 3 months after the procedure.
Read the detailed description
Alcohol neurolysis of the genicular nerve is a procedure that involves injecting alcohol around the nerve branches that supply sensation to the knee joint. The alcohol destroys the nerve fibers and blocks the transmission of pain signals from the knee to the brain. This technique can be used to treat chronic knee pain caused by osteoarthritis (OA).
Several studies have reported that alcohol neurolysis of the genicular nerve can provide significant pain relief and functional improvement in patients with knee OA or postoperative pain. For example, Dass et al. (1) reported two cases of alcohol neurolysis of the genicular nerve using fluoroscopy and ultrasonography in patients with knee OA or persistent postsurgical pain of the knee. Both patients had more than 50% reduction in their numerical rating scale (NRS) scores and improved range of motion and quality of life at 3 months follow-up.
Ultrasonography-guided genicular nerve alcohol neurolysis is prominent with its easy applicability and low cost. There are no studies in the literature evaluating the efficacy of genicular nerve alcohol neurolysis for chronic knee OA. In this prospective study, the investigators will evaluate the NRS and WOMAC scores of patients who underwent genicular nerve alcohol neurolysis for chronic knee OA before, 1, and 3 months after the procedure. In addition, the incidence of procedure-related adverse events (such as paresthesia) recorded in patient records will be analyzed.
- Dass RM et al. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain 2019; 32 (3): 223-227. https://www.epain.org/journal/view.html?doi=10.3344/kjp.2019.32.3.223
- Conditions
- Knee Pain Chronic
- Keywords
- Osteoarthritis, Pain, Ultrasonography, Paresthesia
- Medical subject headings
- Osteoarthritis, Pain, Paresthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.
Measured: Change from Baseline NRS at 1 and 3 months
Secondary outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain
Measured: Change from Baseline WOMAC at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start9 May 2023
- Primary completion1 Nov 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060678
- Sponsor's protocol ID
- Genicular alcohol neurolysis
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Genicular Nerve Alcohol Neurolysis in the Management of Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT06060678
- Acronym / sponsor ID
- Genicular alcohol neurolysis
- Conditions
- Knee Pain Chronic
- Keywords
- Osteoarthritis, Pain, Ultrasonography, Paresthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). NRS and WOMAC scores will be evaluated before, 1, and 3 months after the procedure.
Detailed description
Alcohol neurolysis of the genicular nerve is a procedure that involves injecting alcohol around the nerve branches that supply sensation to the knee joint. The alcohol destroys the nerve fibers and blocks the transmission of pain signals from the knee to the brain. This technique can be used to treat chronic knee pain caused by osteoarthritis (OA).
Several studies have reported that alcohol neurolysis of the genicular nerve can provide significant pain relief and functional improvement in patients with knee OA or postoperative pain. For example, Dass et al. (1) reported two cases of alcohol neurolysis of the genicular nerve using fluoroscopy and ultrasonography in patients with knee OA or persistent postsurgical pain of the knee. Both patients had more than 50% reduction in their numerical rating scale (NRS) scores and improved range of motion and quality of life at 3 months follow-up.
Ultrasonography-guided genicular nerve alcohol neurolysis is prominent with its easy applicability and low cost. There are no studies in the literature evaluating the efficacy of genicular nerve alcohol neurolysis for chronic knee OA. In this prospective study, the investigators will evaluate the NRS and WOMAC scores of patients who underwent genicular nerve alcohol neurolysis for chronic knee OA before, 1, and 3 months after the procedure. In addition, the incidence of procedure-related adverse events (such as paresthesia) recorded in patient records will be analyzed.
- Dass RM et al. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain 2019; 32 (3): 223-227. https://www.epain.org/journal/view.html?doi=10.3344/kjp.2019.32.3.223
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who underwent genicular nerve alcohol neurolysis for knee osteoarthritis pain
Key inclusion criteria (4 listed)
- Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
- Permanent pain for more than 6 months
- Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
- Pain with conservative methods such as analgesics and physiotherapy treatment failure
Key exclusion criteria (6 listed)
- History of intra-articular knee intervention in the last 6 months
- Cognitive impairment
- Hepatic or renal insufficiency
- Severe psychiatric illness
- Local or systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric rating scale (NRS)
Time frame: Change from Baseline NRS at 1 and 3 months
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.
1 secondary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change from Baseline WOMAC at 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Pain Chronic, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) (time frame: Change from Baseline NRS at 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.