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AzTrials

Knee OsteoarthritisPhase 2NCT00988468

Manual Therapy Versus Exercise on Knee Osteoarthritis

A Phase 2 study testing Manual Therapy, Therapeutic Exercise and Video Observation in people with Knee Osteoarthritis, run by Texas Tech University Health Sciences Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Manual Therapy, Therapeutic Exercise and Video Observation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
1 siteUnited States
Study dates
Oct 2009to Aug 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosis of knee osteoarthritis.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

Other trials in United States

About this study

Official title: 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.

Being tested
Manual Therapy, Therapeutic Exercise, Video Observation
Keywords
Knee Osteoarthritis, Manual Therapy, Therapeutic Exercise, Ultrasound, Effusion
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual TherapyProcedure or surgery

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

  • Therapeutic ExerciseBehavioural

    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).

  • Video ObservationBehavioural

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

Study groups in NCT00988468
Study groupRoleWhat they receive
Manual TherapyExperimentalSubjects will receive oscillatory (grade 1 \& 2) manual knee mobilization for 15 minutes at various knee range of motion positions.
Receives: Procedure: Manual Therapy
Therapeutic ExerciseExperimentalSubjects will perform 15 minutes of combined resistance exercise and aerobic exercise.
Receives: Behavioral: Therapeutic Exercise
ControlPlacebo comparatorSubjects will watch a 15 minute instructional video on a health topic.
Receives: Behavioral: Video Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suprapatellar effusion measured via diagnostic ultrasound

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

Secondary outcomes (3)

  1. Pain Visual Analog Scale

    Measured: Outcome measure will be measured 3 minutes prior to intervention and 3 minutes after intervention.

  2. Goniometric knee arc range of motion

    Measured: Outcome measure will be measured 5 minutes prior to intervention and 5 minutes after intervention.

  3. Western Ontario and McMaster Universities Index of osteoarthritis of the knee

    Measured: Outcome measure will be measured 12 minutes prior to intervention and 7 minutes after intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionMay 2010
  4. Study completionAug 2010

Why it stopped: Study failed to recruit a sufficient number of subjects in the time anticipated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988468
Sponsor's protocol ID
L10-004
Status last verified
Nov 2010
First submitted
30 Sep 2009
Last updated
16 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

    PubMed 18163497

  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.

    PubMed 18279766

  • Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available.

    PubMed 16543327

  • Ottawa panel evidence-based clinical practice guidelines for therapeutic exercises and manual therapy in the management of osteoarthritis. Phys Ther. 2005 Sep;85(9):907-71.

    PubMed 16117601

  • Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.

    PubMed 15478147

  • Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.

    PubMed 16777467

  • Wright A. Hypoalgesia post-manipulative therapy: a review of a potential neurophysiological mechanism. Man Ther. 1995 Nov;1(1):11-6. doi: 10.1054/math.1995.0244.

    PubMed 11327789

  • Sambajon VV, Cillo JE Jr, Gassner RJ, Buckley MJ. The effects of mechanical strain on synovial fibroblasts. J Oral Maxillofac Surg. 2003 Jun;61(6):707-12. doi: 10.1053/joms.2003.50141.

    PubMed 12796883

  • Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.

    PubMed 16314677

  • Coates G, O'Brodovich H, Goeree G. Hindlimb and lung lymph flows during prolonged exercise. J Appl Physiol (1985). 1993 Aug;75(2):633-8. doi: 10.1152/jappl.1993.75.2.633.

    PubMed 8226462

  • Havas E, Lehtonen M, Vuorela J, Parviainen T, Vihko V. Albumin clearance from human skeletal muscle during prolonged steady-state running. Exp Physiol. 2000 Nov;85(6):863-8.

    PubMed 11187981

  • de Miguel Mendieta E, Cobo Ibanez T, Uson Jaeger J, Bonilla Hernan G, Martin Mola E. Clinical and ultrasonographic findings related to knee pain in osteoarthritis. Osteoarthritis Cartilage. 2006 Jun;14(6):540-4. doi: 10.1016/j.joca.2005.12.012.

    PubMed 16735196

  • Conaghan P, D'Agostino MA, Ravaud P, Baron G, Le Bars M, Grassi W, Martin-Mola E, Wakefield R, Brasseur JL, So A, Backhaus M, Malaise M, Burmester G, Schmidely N, Emery P, Dougados M. EULAR report on the use of ultrasonography in painful knee osteoarthritis. Part 2: exploring decision rules for clinical utility. Ann Rheum Dis. 2005 Dec;64(12):1710-4. doi: 10.1136/ard.2005.038026. Epub 2005 May 5.

    PubMed 15878902

  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

    PubMed 3741515

  • Dexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995 Apr;82(4):896-902. doi: 10.1097/00000542-199504000-00012.

    PubMed 7717561

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Manual Therapy, Therapeutic Exercise and Video Observation in people with Knee Osteoarthritis, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study failed to recruit a sufficient number of subjects in the time anticipated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988468, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.

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