Manual Therapy Versus Exercise on Knee Osteoarthritis

Phase 2

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Manual Therapy; Behavioral: Therapeutic Exercise; Behavioral: Video Observation

• Registration Number: NCT00988468
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-30
• Study Start: 2009-10
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-15
• Last Update Posted: 2010-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Therapy	Manual Therapy	Subjects will receive oscillatory (grade 1 \& 2) manual knee mobilization for 15 minutes at various knee range of motion positions.
Therapeutic Exercise	Therapeutic Exercise	Subjects will perform 15 minutes of combined resistance exercise and aerobic exercise.
Control	Video Observation	Subjects will watch a 15 minute instructional video on a health topic.

Primary Outcome Measures

Name	Time	Method
Suprapatellar effusion measured via diagnostic ultrasound	Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention.

Secondary Outcome Measures

Name	Time	Method
Pain Visual Analog Scale	Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention.
Goniometric knee arc range of motion	Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention.
Western Ontario and McMaster Universities Index of osteoarthritis of the knee	Outcome measure will be measured 12 minutes prior to intervention and 7 minutes after intervention.

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States