Chronic PainPhase 4NCT02632565
Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis
A Phase 4 study testing Lidocaine and Saline in people with Chronic Pain, run by H. Evren Eker.
Trial summary
In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Aug 2015
- Phase
- Phase 4
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee
- pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee OA
Who cannot join
- the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery
About this study
Official title: Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis
In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.
Read the detailed description
Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26) received intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL saline into painful knee for 3 times with one week intervals under USG guidance. VAS and WOMAC scale including pain, stiffness and physical function was used for the assessment of patients with osteoarthritis. Analgesic requirements were also recorded.
The primary outcome parameter of this study was the pain scores. The sample size for the primary variable was calculated based on a standard deviation of 20 mm estimated from a previous study. A power analysis with a type II error of 20% at a two-sided 5% significance level estimated 22 patients per group to be included. Investigators included 26 patients per groups for possible missing date. χ2 test for categorical data and independent samples t-test for the comparison of VAS and WOMAC scores between groups were used for statistical analysis.
- Conditions
- Chronic Pain
- Being tested
- Lidocaine, Saline
- Keywords
- osteoarthritis, lidocaine, pain, ultrasound
- Medical subject headings
- Chronic Pain, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| intra-articular 0.5% lidocaine | Active comparator | intra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals Receives: Drug: Lidocaine |
| intra-articular saline | Active comparator | intra-articular 7 mL saline injection for 3 times with one week intervals Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores according to visual analog scale
Measured: 3 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2009
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Evren Eker
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Sponsor-investigator, H. Evren Eker, Baskent University
- Investigators
- Anis Aribogan, Prof, Study chair, Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632565
- Sponsor's protocol ID
- KA08/83
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Elhakim M, Nafie M, Eid A, Hassin M. Combination of intra-articular tenoxicam, lidocaine, and pethidine for outpatient knee arthroscopy. Acta Anaesthesiol Scand. 1999 Sep;43(8):803-8. doi: 10.1034/j.1399-6576.1999.430804.x.
PubMed 10492407Pietruck C, Grond S, Xie GX, Palmer PP. Local anesthetics differentially inhibit sympathetic neuron-mediated and C fiber-mediated synovial neurogenic plasma extravasation. Anesth Analg. 2003 May;96(5):1397-1402. doi: 10.1213/01.ANE.0000060454.34258.D3.
PubMed 12707141
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis
- ClinicalTrials.gov ID
- NCT02632565
- Acronym / sponsor ID
- KA08/83
- Conditions
- Chronic Pain
- Keywords
- osteoarthritis, lidocaine, pain, ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- H. Evren EkerUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- Dec 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Dec 2015 (estimated)
- 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.
In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.
Detailed description
Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26) received intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL saline into painful knee for 3 times with one week intervals under USG guidance. VAS and WOMAC scale including pain, stiffness and physical function was used for the assessment of patients with osteoarthritis. Analgesic requirements were also recorded.
The primary outcome parameter of this study was the pain scores. The sample size for the primary variable was calculated based on a standard deviation of 20 mm estimated from a previous study. A power analysis with a type II error of 20% at a two-sided 5% significance level estimated 22 patients per group to be included. Investigators included 26 patients per groups for possible missing date. χ2 test for categorical data and independent samples t-test for the comparison of VAS and WOMAC scores between groups were used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-articular 0.5% lidocaine | Active comparator | Drug: Lidocaineintra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals |
| intra-articular saline | Active comparator | Drug: Salineintra-articular 7 mL saline injection for 3 times with one week intervals |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee
- pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee OA
Key exclusion criteria (1 listed)
- the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/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 |
|---|---|---|
| Lidocaine | Drug | intra-articular 0.5% lidocaine |
| Saline | Drug | intra-articular saline |
Primary outcome
Pain scores according to visual analog scale
Time frame: 3 months after the treatment
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 16 Dec 2015.
- Background: PubMed 10492407Elhakim M, Nafie M, Eid A, Hassin M. Combination of intra-articular tenoxicam, lidocaine, and pethidine for outpatient knee arthroscopy. Acta Anaesthesiol Scand. 1999 Sep;43(8):803-8. doi: 10.1034/j.1399-6576.1999.430804.x.
- Background: PubMed 12707141Pietruck C, Grond S, Xie GX, Palmer PP. Local anesthetics differentially inhibit sympathetic neuron-mediated and C fiber-mediated synovial neurogenic plasma extravasation. Anesth Analg. 2003 May;96(5):1397-1402. doi: 10.1213/01.ANE.0000060454.34258.D3.
- Individual participant dataSharing planned: No
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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.
Anis Aribogan, Prof study chair
Coordinator
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Saline in people with Chronic Pain, run by H. Evren Eker.
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 1 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 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain scores according to visual analog scale (time frame: 3 months after the treatment). 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 NCT02632565, which also lists 2 linked publications.
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 16 Dec 2015.