Osteoarthritis, KneeNCT03806322
A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis
A study testing Intermittent Pneumatic Compression and Cold-pack in people with Osteoarthritis, Knee, run by Marmara University.
Trial summary
In this study, we compared the effects of intermittent pneumatic compression along with conventional treatment and cold-pack treatment along with conventional treatment on clinical outcomes in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intermittent Pneumatic Compression and Cold-pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2011to 1 Jun 2012
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR), and were considered as stage 2 and 3 according to Kellgren-Lawrence criteria.
Who cannot join
- Exclusion criteria were previous knee surgery, malignancy, circulation disorder, and conditions preventing exercise or causing muscle weakness, pregnancy, diagnosis of mental disorder, scar tissue, or metal implants.
About this study
Official title: A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial
In this study, we compared the effects of intermittent pneumatic compression along with conventional treatment and cold-pack treatment along with conventional treatment on clinical outcomes in patients with knee osteoarthritis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intermittent Pneumatic Compression, Cold-pack
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Pneumatic CompressionOther
The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.
Cold-packOther
The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.
| Study group | Role | What they receive |
|---|---|---|
| Cold-pack Group | Experimental | One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs Receives: Other: Cold-pack |
| Intermittent Pneumatic Compression | Experimental | The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression Receives: Other: Intermittent Pneumatic Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Swelling
Knee swelling was measured with a tape measure.
Measured: 3 minutes
Pain Intensity
A Visual Analogue Scale was used to measure pain intensity.
Measured: 3 minutes
Secondary outcomes (3)
Range of Motion
A universal goniometer was used to measure range of knee flexion.
Measured: 3 minutes
Muscle Strength
A digital dynamometer (J-TECH Power Track II Commander, USA) was used to measure quadriceps femoris and hamstring muscle strength.
Measured: 10 minutes
Functional Status
The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used to evaluate pain, stiffness and physical function.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Nov 2011
- Primary completion31 May 2012
- Study completion1 Jun 2012
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 Osteoarthritis, KneeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806322
- Sponsor's protocol ID
- MU2019VT
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sari Z, Aydogdu O, Demirbuken I, Yurdalan SU, Polat MG. A Better Way to Decrease Knee Swelling in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2019 May 2;2019:8514808. doi: 10.1155/2019/8514808. eCollection 2019.
PubMed 31191790
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03806322
- Acronym / sponsor ID
- MU2019VT
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 May 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 16 Jan 2019 (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.
In this study, we compared the effects of intermittent pneumatic compression along with conventional treatment and cold-pack treatment along with conventional treatment on clinical outcomes in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold-pack Group | Experimental | Other: Cold-packOne group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs |
| Intermittent Pneumatic Compression | Experimental | Other: Intermittent Pneumatic CompressionThe second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR), and were considered as stage 2 and 3 according to Kellgren-Lawrence criteria.
Key exclusion criteria (1 listed)
- Exclusion criteria were previous knee surgery, malignancy, circulation disorder, and conditions preventing exercise or causing muscle weakness, pregnancy, diagnosis of mental disorder, scar tissue, or metal implants.
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 |
|---|---|---|
| Intermittent Pneumatic CompressionThe group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression. | Other | Intermittent Pneumatic Compression |
| Cold-packThe group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs. | Other | Cold-pack Group |
Primary outcome
Knee Swelling
Time frame: 3 minutes
Knee swelling was measured with a tape measure.
Pain Intensity
Time frame: 3 minutes
A Visual Analogue Scale was used to measure pain intensity.
3 secondary outcomes
Range of Motion
Time frame: 3 minutes
Muscle Strength
Time frame: 10 minutes
Functional Status
Time frame: 10 minutes
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 Jan 2019.
- Derived from this study: PubMed 31191790Sari Z, Aydogdu O, Demirbuken I, Yurdalan SU, Polat MG. A Better Way to Decrease Knee Swelling in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2019 May 2;2019:8514808. doi: 10.1155/2019/8514808. eCollection 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pneumatic Compression and Cold-pack in people with Osteoarthritis, Knee, run by Marmara University.
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 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 Jan 2019. 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.
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?
Knee Swelling (time frame: 3 minutes). The study lists 2 primary outcomes in all. 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 NCT03806322, 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 16 Jan 2019.