NCT03806322

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2012

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 14, 2019

Last Update Submit

January 14, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Knee Swelling

    Knee swelling was measured with a tape measure.

    3 minutes

  • Pain Intensity

    A Visual Analogue Scale was used to measure pain intensity.

    3 minutes

Secondary Outcomes (3)

  • Range of Motion

    3 minutes

  • Muscle Strength

    10 minutes

  • Functional Status

    10 minutes

Study Arms (2)

Cold-pack Group

EXPERIMENTAL

One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs

Other: Cold-pack

Intermittent Pneumatic Compression

EXPERIMENTAL

The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression

Other: Intermittent Pneumatic Compression

Interventions

The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.

Intermittent Pneumatic Compression

The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.

Cold-pack Group

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

November 1, 2011

Primary Completion

May 31, 2012

Study Completion

June 1, 2012

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share