Manual Therapy Versus Exercise on Knee Osteoarthritis

This study has been terminated.
(Study failed to recruit a sufficient number of subjects in the time anticipated.)
Sponsor:
Information provided by:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00988468
First received: September 30, 2009
Last updated: November 15, 2010
Last verified: November 2010

September 30, 2009
November 15, 2010
October 2009
May 2010   (final data collection date for primary outcome measure)
Suprapatellar effusion measured via diagnostic ultrasound [ Time Frame: Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988468 on ClinicalTrials.gov Archive Site
  • Pain Visual Analog Scale [ Time Frame: Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention. ] [ Designated as safety issue: No ]
  • Goniometric knee arc range of motion [ Time Frame: Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Manual Therapy Versus Exercise on Knee Osteoarthritis
Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Procedure: Manual Therapy
    Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.
  • Behavioral: Therapeutic Exercise
    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).
  • Behavioral: Video Observation
    Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.
  • Experimental: Manual Therapy
    Subjects will receive oscillatory (grade 1 & 2) manual knee mobilization for 15 minutes at various knee range of motion positions.
    Intervention: Procedure: Manual Therapy
  • Experimental: Therapeutic Exercise
    Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.
    Intervention: Behavioral: Therapeutic Exercise
  • Placebo Comparator: Control
    Subjects will watch a 15 minute instructional video on a health topic.
    Intervention: Behavioral: Video Observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00988468
L10-004
No
Daniel R. Poulsen, II/Assistant Professor, Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
Not Provided
Principal Investigator: Dan Poulsen, PhD Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP