Manual Therapy Versus Exercise on Knee Osteoarthritis

NCT00988468 | Terminated Phase 2

• 1 other identifier: L10-004
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Manual Therapy; Therapeutic Exercise; Ultrasound; Effusion

Outcome Measures

Primary Outcomes (1)

• Suprapatellar effusion measured via diagnostic ultrasound

  Outcome measure will be measured 1 minute prior to intervention and 1 minute after intervention.

Secondary Outcomes (3)

• 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.

Study Arms (3)

Manual Therapy

EXPERIMENTAL

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

Procedure: Manual Therapy

Therapeutic Exercise

EXPERIMENTAL

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

Behavioral: Therapeutic Exercise

Control

PLACEBO COMPARATOR

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

Behavioral: Video Observation

Interventions

Manual Therapy PROCEDURE

Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.

Manual Therapy

Therapeutic Exercise BEHAVIORAL

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).

Therapeutic Exercise

Video Observation BEHAVIORAL

Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of knee osteoarthritis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Dan Poulsen, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 2, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

US (1)