Knee OsteoarthritisNCT04782401
The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis
A study testing Ultrasound guided genicular nerve block + exercise treatment and Physical therapy + exercise treatment in people with Knee Osteoarthritis, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
Trial summary
Goal: Comparison of the effects of genicular nerve block with usg and physical therapy on pain, physical function for patients with knee osteoarthritis. Material and Methods:102 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study.Patients were randomized to two… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ultrasound guided genicular nerve block + exercise treatment and Physical therapy + exercise treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 15 Feb 2021
- Phase
- Interventional
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with knee osteoarthritis according to the 1986 American College of Rheumatology (ACR) criteria and were in Kellgren-Lawrence (KL) Grade 2-3
- Being between the ages of 45-65
Who cannot join
- Severe knee trauma history within the six month
- Previous intraarticular hyaluronic acid or steroid injection
- Previous use of oral glucosamine
- Meniscal or connective tissue damage
- Those receiving physical therapy within the six month for knee pain
- History of inflamatuary romatologic disease
Show all 10Show fewer
- Pregnancy and breastfeeding
- Malignancy
- Psychiatric disease
- Those with a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Ultrasound Guided Genicular Nerve Block Versus Physical Therapy for Knee Osteoarthritis
Goal: Comparison of the effects of genicular nerve block with usg and physical therapy on pain, physical function for patients with knee osteoarthritis.
Material and Methods:102 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study.Patients were randomized to two groups, first being injected a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves with exercise treatment and second being ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer with exercise treatment.For the first group, the ultrasound we used: 12 MHz linear transducer. (Logic E9-GE, USA).The transducer was first placed parallel to the long bone shaft and moved up or down to identify the epicondyle of the long bone. The genicular arteries were identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound.Accordingly, GNB target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve. , Visual Analogue Scale for pain(VAS) was primer outcome measurement, Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC) and six minute walk tests were seconder outcome measurements of the study applied before, after (two weeks) and 12th weeks of treatment. Primer endpoint of the study is decrease at least 40% in VAS values at 2nd week, second endpoint is the improvement in the womac and 6-minute walk test observed in the 2nd week continues until the 12th week.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ultrasound guided genicular nerve block + exercise treatment, Physical therapy + exercise treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided genicular nerve block + exercise treatmentOther
This method was used to inject a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves plus exercise treatment
Physical therapy + exercise treatmentDevice
Ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer and exercise treatment.
| Study group | Role | What they receive |
|---|---|---|
| Genicular Nerve Block | Active comparator | Not described Receives: Other: Ultrasound guided genicular nerve block + exercise treatment |
| Physical Therapy | Active comparator | Not described Receives: Device: Physical therapy + exercise treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) score
A scale for the use of measuring pain. Minimum score of the scale is 0 and maximum is 10. Higher scores mean worse outcomes.
Measured: Pre-intervention, Change from Baseline visual analog scale at 12th weeks
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
WOMAC is a scale to assess disease-related functional status and disability. It consists of three parts with 24 simple questions in total. Five questions are related to pain (WOMAC-A), two questions to morning stiffness (WOMAC-B), and the remaining 17 questions to physical condition (WOMAC-C). Each question is scored using 4-point Likert scale (0= None, 1= Mild, 2= Moderate, 3= Severe, 4= Very severe). Higher scores indicate severe pain, increased stiffness, and functional failure. Minimum score of the scale is 0 and maximum is 100. Higher scores mean worse outcomes.
Measured: Pre-intervention, Change from baseline WOMAC score at 12th weeks
Six minute walk test
It is an objective method to evaluate exercise tolerance. It was performed on an unobstructed bare 30 meters (m) floor where every 3 meters were marked. The patients were allowed to complete the test by reducing their walking speed or stopping and getting some rest, if needed. Maximum walking distance (meters) within six min was measured. Higher distance means better outcome.
Measured: Pre-intervention, Change from baseline six minute walk test at 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2020
- Primary completion1 Feb 2021
- Study completion15 Feb 2021
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 Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Elif becenen, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782401
- Sponsor's protocol ID
- TRASD-TG-GB
- Status last verified
- Jan 2022
- First submitted
- 19 Feb 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guler T, Yurdakul FG, Onder ME, Erdogan F, Yavuz K, Becenen E, Uckun A, Bodur H. Ultrasound-guided genicular nerve block versus physical therapy for chronic knee osteoarthritis: a prospective randomised study. Rheumatol Int. 2022 Apr;42(4):591-600. doi: 10.1007/s00296-022-05101-8. Epub 2022 Feb 14.
PubMed 35165769
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound Guided Genicular Nerve Block Versus Physical Therapy for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04782401
- Acronym / sponsor ID
- TRASD-TG-GB
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 4 Mar 2021 (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.
Goal: Comparison of the effects of genicular nerve block with usg and physical therapy on pain, physical function for patients with knee osteoarthritis.
Material and Methods:102 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study.Patients were randomized to two groups, first being injected a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves with exercise treatment and second being ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer with exercise treatment.For the first group, the ultrasound we used: 12 MHz linear transducer. (Logic E9-GE, USA).The transducer was first placed parallel to the long bone shaft and moved up or down to identify the epicondyle of the long bone. The genicular arteries were identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound.Accordingly, GNB target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve. , Visual Analogue Scale for pain(VAS) was primer outcome measurement, Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC) and six minute walk tests were seconder outcome measurements of the study applied before, after (two weeks) and 12th weeks of treatment. Primer endpoint of the study is decrease at least 40% in VAS values at 2nd week, second endpoint is the improvement in the womac and 6-minute walk test observed in the 2nd week continues until the 12th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genicular Nerve Block | Active comparator | Other: Ultrasound guided genicular nerve block + exercise treatment |
| Physical Therapy | Active comparator | Device: Physical therapy + exercise treatment |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with knee osteoarthritis according to the 1986 American College of Rheumatology (ACR) criteria and were in Kellgren-Lawrence (KL) Grade 2-3
- Being between the ages of 45-65
Key exclusion criteria (10 listed)
- Severe knee trauma history within the six month
- Previous intraarticular hyaluronic acid or steroid injection
- Previous use of oral glucosamine
- Meniscal or connective tissue damage
- Those receiving physical therapy within the six month for knee pain
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 |
|---|---|---|
| Ultrasound guided genicular nerve block + exercise treatmentThis method was used to inject a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves plus exercise treatment | Other | Genicular Nerve Block |
| Physical therapy + exercise treatmentTen sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer and exercise treatment. | Device | Physical Therapy |
Primary outcome
Visual analog scale (VAS) score
Time frame: Pre-intervention, Change from Baseline visual analog scale at 12th weeks
A scale for the use of measuring pain. Minimum score of the scale is 0 and maximum is 10. Higher scores mean worse outcomes.
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Pre-intervention, Change from baseline WOMAC score at 12th weeks
Six minute walk test
Time frame: Pre-intervention, Change from baseline six minute walk test at 12th weeks
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 7 Feb 2022.
- Derived from this study: PubMed 35165769Guler T, Yurdakul FG, Onder ME, Erdogan F, Yavuz K, Becenen E, Uckun A, Bodur H. Ultrasound-guided genicular nerve block versus physical therapy for chronic knee osteoarthritis: a prospective randomised study. Rheumatol Int. 2022 Apr;42(4):591-600. doi: 10.1007/s00296-022-05101-8. Epub 2022 Feb 14.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided genicular nerve block + exercise treatment and Physical therapy + exercise treatment in people with Knee Osteoarthritis, run by Turkish League Against Rheumatism 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 2 inclusion and 10 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 7 Feb 2022. 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?
Visual analog scale (VAS) score (time frame: Pre-intervention, Change from Baseline visual analog scale at 12th weeks). 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 NCT04782401, 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 7 Feb 2022.