Osteoarthritis, KneeNCT02358707
Is Phonophoresis Treatment Effective?
A study testing Ibuprofen phonophoresis in people with Osteoarthritis, Knee, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen phonophoresis will be analyzed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ibuprofen phonophoresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to May 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- having diagnosed as osteoarthritis
Who cannot join
- surgery at knee
- trauma at knee
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çukurova Üniversitesi
Adana
Bayram Kelle, bayramkelle@yahoo.com
About this study
Official title: Is Phonophoresis Treatment Effective? Determination of Ibuprofen Levels by Microextraction and HPLC (High Liquid Pressure Chromatography) Method in the Tissues of the Patients With Knee Osteoarthritis?
The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen phonophoresis will be analyzed.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ibuprofen phonophoresis
- Keywords
- ibuprofen phonophoresis, High performance liquid chromatography
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen phonophoresisOther
| Study group | Role | What they receive |
|---|---|---|
| phonophoresis in knee osteoarthritis | Experimental | Ibuprofen phonophoresis in patients with knee osteoarthritis Receives: Other: Ibuprofen phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of ibuprofen in bone by Microextraction and HPLC (High Liquid Pressure Chromatography)
Effectiveness and safety
Measured: 1 year
level of ibuprofen in synovial membrana by Microextraction and HPLC (High Liquid Pressure Chromatography)
Effectiveness and safety
Measured: 1 year
level of ibuprofen in synovial fluid by Microextraction and HPLC (High Liquid Pressure Chromatography)
Effectiveness and safety
Measured: 1 year
Secondary outcomes (1)
Visual Analog Scale (VAS)
VAS score after phonophoresis treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionMar 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bayram Kelle, Cukurova University
- Investigators
- Bayram Kelle, Study director, Çukurova University, Faculty of Medicine, Adana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358707
- Sponsor's protocol ID
- BAP
- Status last verified
- Feb 2015
- First submitted
- 15 Jan 2015
- Last updated
- 9 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Phonophoresis Treatment Effective? Determination of Ibuprofen Levels by Microextraction and HPLC (High Liquid Pressure Chromatography) Method in the Tissues of the Patients With Knee Osteoarthritis?
- ClinicalTrials.gov ID
- NCT02358707
- Acronym / sponsor ID
- BAP
- Conditions
- Osteoarthritis, Knee
- Keywords
- ibuprofen phonophoresis, High performance liquid chromatography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 9 Feb 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.
The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen phonophoresis will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phonophoresis in knee osteoarthritis | Experimental | Other: Ibuprofen phonophoresisIbuprofen phonophoresis in patients with knee osteoarthritis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- having diagnosed as osteoarthritis
Key exclusion criteria (2 listed)
- surgery at knee
- trauma at knee
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 |
|---|---|---|
| Ibuprofen phonophoresis | Other | phonophoresis in knee osteoarthritis |
Primary outcome
level of ibuprofen in bone by Microextraction and HPLC (High Liquid Pressure Chromatography)
Time frame: 1 year
Effectiveness and safety
level of ibuprofen in synovial membrana by Microextraction and HPLC (High Liquid Pressure Chromatography)
Time frame: 1 year
Effectiveness and safety
level of ibuprofen in synovial fluid by Microextraction and HPLC (High Liquid Pressure Chromatography)
Time frame: 1 year
Effectiveness and safety
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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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.
Bayram Kelle study director
Çukurova University, Faculty of Medicine, Adana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen phonophoresis in people with Osteoarthritis, Knee, run by Cukurova University 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bayram Kelle (9003223386060-3161, bayramkelle@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of ibuprofen in bone by Microextraction and HPLC (High Liquid Pressure Chromatography) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 9 Feb 2015.