Back to resultsA Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Pneumatic Compression
Cold-pack
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cold-pack Group
Intermittent Pneumatic Compression
Arm Description
One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs
The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression
Outcomes
Primary Outcome Measures
Knee Swelling
Knee swelling was measured with a tape measure.
Pain Intensity
A Visual Analogue Scale was used to measure pain intensity.
Secondary Outcome Measures
Range of Motion
A universal goniometer was used to measure range of knee flexion.
Muscle Strength
A digital dynamometer (J-TECH Power Track II Commander, USA) was used to measure quadriceps femoris and hamstring muscle strength.
Functional Status
The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used to evaluate pain, stiffness and physical function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03806322
Brief Title
A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis
Official Title
A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2011 (Actual)
Primary Completion Date
May 31, 2012 (Actual)
Study Completion Date
June 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold-pack Group
Arm Type
Experimental
Arm Description
One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs
Arm Title
Intermittent Pneumatic Compression
Arm Type
Experimental
Arm Description
The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression
Intervention Type
Other
Intervention Name(s)
Intermittent Pneumatic Compression
Intervention Description
The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.
Intervention Type
Other
Intervention Name(s)
Cold-pack
Intervention Description
The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.
Primary Outcome Measure Information:
Title
Knee Swelling
Description
Knee swelling was measured with a tape measure.
Time Frame
3 minutes
Title
Pain Intensity
Description
A Visual Analogue Scale was used to measure pain intensity.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Range of Motion
Description
A universal goniometer was used to measure range of knee flexion.
Time Frame
3 minutes
Title
Muscle Strength
Description
A digital dynamometer (J-TECH Power Track II Commander, USA) was used to measure quadriceps femoris and hamstring muscle strength.
Time Frame
10 minutes
Title
Functional Status
Description
The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used to evaluate pain, stiffness and physical function.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31191790
Citation
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.
Results Reference
derived
Learn more about this trial
A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis
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