3-NeedleNCT07853170
3-Needle vs 5-Needle of Genicular Nerve Block on Pain and Quality of Life in Knee Osteoarthritis
A study testing 3-nerve-targeted group and 5-nerve-targeted group in people with 3-Needle and 5-Needle, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the 3-needle and 5-needle of genicular nerve block on pain and quality of life in Knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 3-Needle, 5-Needle, Genicular Nerve Block
- What is being tested?
- 3-nerve-targeted group and 5-nerve-targeted group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Both sexes.
- Patients with unilateral chronic knee pain for more than 3 months.
- Patients received conservative treatment for at least 3 months.
- Diagnosed Knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria, and grade greater than or equal to Kellgren-Lawrence grade 2.
Who cannot join
- Chronic knee pain is due to causes other than KOA, such as connective tissue diseases, lumbar radicular neuropathy (spondylolisthesis, spinal stenosis), or sciatic pain.
- Knee effusion.
- Neuro/psychiatric disorders.
- History of intra-articular injection in the prior 3 months.
- Prior knee surgery.
- Active systemic or local knee infections; anticoagulant use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of 3-Needle vs 5-Needle of Genicular Nerve Block on Pain and Quality of Life in Knee Osteoarthritis
This study aims to compare the 3-needle and 5-needle of genicular nerve block on pain and quality of life in Knee osteoarthritis (KOA).
Read the detailed description
Knee osteoarthritis (KOA) is a common musculoskeletal disorder characterized by degeneration of articular cartilage and the subchondral bone. It leads to pain, stiffness, and functional decline in the affected knee joints.
Currently, the classical 3- nerve protocol targeting the superior medial, superior lateral, and inferior medial genicular nerves is the most commonly used technique for radiofrequency procedures.
Therefore, a five-needle Genicular nerve blocks (GNB) technique has been proposed to provide a more comprehensive blockade by targeting additional sensory branches.
- Conditions
- 3-Needle, 5-Needle, Genicular Nerve Block, Pain, Quality of Life, Knee Osteoarthritis
- Being tested
- 3-nerve-targeted group, 5-nerve-targeted group
- Medical subject headings
- Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-nerve-targeted groupOther
Patients will receive 3-nerve protocol.
5-nerve-targeted groupOther
Patients will receive 5-nerve protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group I (3-nerve-targeted group) | Experimental | Patients will receive 3-nerve protocol. Receives: Other: 3-nerve-targeted group |
| Group II (5-nerve-targeted group) | Experimental | Patients will receive 5-nerve protocol. Receives: Other: 5-nerve-targeted group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 6 months postoperatively
Secondary outcomes (3)
Measurement of Quality of life
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered health status questionnaire and consists of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Accordingly, higher scores on the WOMAC indicate worse pain, stiffness, and functional limitation. The WOMAC will be assessed at each follow-up point
Measured: 6 months postoperatively
Patients' opioid medication use
Patients' opioid medication use will be evaluated before treatment and at 6 months after treatment.
Measured: 6 months after treatment
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start4 Oct 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 3-NeedleStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853170
- Sponsor's protocol ID
- 36265PR192/8/26
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.
PubMed 37745043
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of 3-Needle vs 5-Needle of Genicular Nerve Block on Pain and Quality of Life in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07853170
- Acronym / sponsor ID
- 36265PR192/8/26
- Conditions
- 3-Needle, 5-Needle, Genicular Nerve Block, Pain, Quality of Life, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Oct 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 1 Oct 2026 (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 aims to compare the 3-needle and 5-needle of genicular nerve block on pain and quality of life in Knee osteoarthritis (KOA).
Detailed description
Knee osteoarthritis (KOA) is a common musculoskeletal disorder characterized by degeneration of articular cartilage and the subchondral bone. It leads to pain, stiffness, and functional decline in the affected knee joints.
Currently, the classical 3- nerve protocol targeting the superior medial, superior lateral, and inferior medial genicular nerves is the most commonly used technique for radiofrequency procedures.
Therefore, a five-needle Genicular nerve blocks (GNB) technique has been proposed to provide a more comprehensive blockade by targeting additional sensory branches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (3-nerve-targeted group) | Experimental | Other: 3-nerve-targeted groupPatients will receive 3-nerve protocol. |
| Group II (5-nerve-targeted group) | Experimental | Other: 5-nerve-targeted groupPatients will receive 5-nerve protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Both sexes.
- Patients with unilateral chronic knee pain for more than 3 months.
- Patients received conservative treatment for at least 3 months.
- Diagnosed Knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria, and grade greater than or equal to Kellgren-Lawrence grade 2.
Key exclusion criteria (6 listed)
- Chronic knee pain is due to causes other than KOA, such as connective tissue diseases, lumbar radicular neuropathy (spondylolisthesis, spinal stenosis), or sciatic pain.
- Knee effusion.
- Neuro/psychiatric disorders.
- History of intra-articular injection in the prior 3 months.
- Prior knee surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-nerve-targeted groupPatients will receive 3-nerve protocol. | Other | Group I (3-nerve-targeted group) |
| 5-nerve-targeted groupPatients will receive 5-nerve protocol. | Other | Group II (5-nerve-targeted group) |
Primary outcome
Degree of pain
Time frame: 6 months postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
3 secondary outcomes
Measurement of Quality of life
Time frame: 6 months postoperatively
Patients' opioid medication use
Time frame: 6 months after treatment
Degree of patient satisfaction
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 37745043Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-nerve-targeted group and 5-nerve-targeted group in people with 3-Needle and 5-Needle, run by Tanta University at 1 site in Egypt.
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 5 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S Elsharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07853170, which also lists 1 linked publication.
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 6 Oct 2026.