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Manual Therapy Versus Exercise on Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy
Therapeutic Exercise
Video Observation
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Manual Therapy, Therapeutic Exercise, Ultrasound, Effusion

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of knee osteoarthritis.

Exclusion Criteria:

  • Inability to ambulate at least 100 feet, ride a stationary bicycle for at least 10 minutes, or lie in the prone position for at least 10 minutes,
  • Intra-articular knee injection within one month of study inception,
  • A history of exercise induced or uncontrolled angina within three months of the study entry,
  • Severe dyspnea at rest,
  • Previous bilateral total knee arthroplasty,
  • Pregnancy, OR
  • The absence of knee pain at the time of recruitment for the study.

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Manual Therapy

Therapeutic Exercise

Control

Arm Description

Subjects will receive oscillatory (grade 1 & 2) manual knee mobilization for 15 minutes at various knee range of motion positions.

Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.

Subjects will watch a 15 minute instructional video on a health topic.

Outcomes

Primary Outcome Measures

Suprapatellar effusion measured via diagnostic ultrasound

Secondary Outcome Measures

Pain Visual Analog Scale
Goniometric knee arc range of motion
Western Ontario and McMaster Universities Index of osteoarthritis of the knee

Full Information

First Posted
September 30, 2009
Last Updated
November 15, 2010
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT00988468
Brief Title
Manual Therapy Versus Exercise on Knee Osteoarthritis
Official Title
Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Study failed to recruit a sufficient number of subjects in the time anticipated.
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Earlier research has shown that exercising while receiving manual therapy improves function and reduces pain in people with knee osteoarthritis. However, very little is known about the mechanisms by which manual therapy and exercise reduce pain and improve function. This study will ask subjects with knee osteoarthritis to receive one of the following interventions: (1) no treatment, (2) exercise only, or (3) manual therapy only. Measures will be taken of the patient's knee range of motion, knee swelling and pain before and after receiving the intervention. These measures will be analyzed to determine what effect exercise and manual therapy applied to the knee have on improving knee range of motion and reducing knee pain and swelling. Swelling will be measured using an ultrasound device which is used to take pictures inside the knee. This type of ultrasound measurement is painless and harmless.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Manual Therapy, Therapeutic Exercise, Ultrasound, Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Experimental
Arm Description
Subjects will receive oscillatory (grade 1 & 2) manual knee mobilization for 15 minutes at various knee range of motion positions.
Arm Title
Therapeutic Exercise
Arm Type
Experimental
Arm Description
Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will watch a 15 minute instructional video on a health topic.
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy
Intervention Description
Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Exercise
Intervention Description
Subjects will perform 5 minutes of lower extremity cycle ergometer with minimal resistance followed by 10 minutes of resistance exercise to the quadriceps at 3 tibiofemoral positions (0 degrees, 30 degrees and 60 degrees of knee flexion).
Intervention Type
Behavioral
Intervention Name(s)
Video Observation
Intervention Description
Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.
Primary Outcome Measure Information:
Title
Suprapatellar effusion measured via diagnostic ultrasound
Time Frame
Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention.
Secondary Outcome Measure Information:
Title
Pain Visual Analog Scale
Time Frame
Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention.
Title
Goniometric knee arc range of motion
Time Frame
Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention.
Title
Western Ontario and McMaster Universities Index of osteoarthritis of the knee
Time Frame
Outcome measure will be measured 12 minutes prior to intervention and 7 minutes after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of knee osteoarthritis. Exclusion Criteria: Inability to ambulate at least 100 feet, ride a stationary bicycle for at least 10 minutes, or lie in the prone position for at least 10 minutes, Intra-articular knee injection within one month of study inception, A history of exercise induced or uncontrolled angina within three months of the study entry, Severe dyspnea at rest, Previous bilateral total knee arthroplasty, Pregnancy, OR The absence of knee pain at the time of recruitment for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Poulsen, PhD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

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Manual Therapy Versus Exercise on Knee Osteoarthritis

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