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
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Procedure: Manual Therapy
Behavioral: Therapeutic Exercise
Behavioral: Video Observation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Manual Therapy Versus Therapeutic Exercise on Knee Osteoarthritis: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Therapy
Subjects will receive oscillatory (grade 1 & 2) manual knee mobilization for 15 minutes at various knee range of motion positions.
Procedure: Manual Therapy
Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.
Experimental: Therapeutic Exercise
Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.
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).
Placebo Comparator: Control
Subjects will watch a 15 minute instructional video on a health topic.
Behavioral: Video Observation
Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988468

Locations
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Dan Poulsen, PhD Texas Tech University Health Sciences Center
  More Information

Publications:

Responsible Party: Daniel R. Poulsen, II/Assistant Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00988468     History of Changes
Other Study ID Numbers: L10-004
Study First Received: September 30, 2009
Last Updated: November 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Knee Osteoarthritis
Manual Therapy
Therapeutic Exercise
Ultrasound
Effusion

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014