A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis

January 14, 2019 updated by: Marmara University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold-pack Group
One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs
Other: Cold-pack
The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.
Experimental: Intermittent Pneumatic Compression
The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression
Other: Intermittent Pneumatic Compression
The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Swelling
Time Frame: 3 minutes
Knee swelling was measured with a tape measure.
3 minutes
Pain Intensity
Time Frame: 3 minutes
A Visual Analogue Scale was used to measure pain intensity.
3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 3 minutes
A universal goniometer was used to measure range of knee flexion.
3 minutes
Muscle Strength
Time Frame: 10 minutes
A digital dynamometer (J-TECH Power Track II Commander, USA) was used to measure quadriceps femoris and hamstring muscle strength.
10 minutes
Functional Status
Time Frame: 10 minutes
The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used to evaluate pain, stiffness and physical function.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

May 31, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU2019VT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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