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Exercise and Pain Sensitivity in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545258
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Brief Summary:

A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability.

While the link between exercise and reduced disability is mediated by e.g. increased muscle strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA patients have both peripheral and central sensitization of pain mechanisms resulting in hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral and central mechanisms but it unknown if exercise affects either of these mechanisms.

It is hypothesized that in knee OA patients exercise reduces the pain sensitivity

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis
Study Start Date : March 2012
Actual Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise
Exercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week.
Other: Exercise
Physiotherapy supervised exercise training. 60 minutes 3 times per week
Other Name: Exercise training

No Intervention: Control

Primary Outcome Measures :
  1. Change from baseline in mechanical pain sensitivity [ Time Frame: Baseline and at 12 weeks ]
    Pain thresholds and temporal summation of pain

Secondary Outcome Measures :
  1. Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine [ Time Frame: Baseline and at 12 weeks ]
  2. Change from baseline in patient reported pain and function [ Time Frame: Baseline and at 12 weeks ]
    KOOS questionnaire

  3. Change from baseline in functional pain test [ Time Frame: Baseline and at 12 weeks ]
    Pain is assessed during continuous tradmill walking at self-selected pace for 20 minutes.

  4. Change from baseline in imaged based quantification of inflammation in the knee [ Time Frame: Baseline and at 12 weeks ]
    Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age above 40 years
  • Clinical diagnosis of tibiofemoral osteoarthritis
  • Radiographic verification of diagnosis (Kellgren&Lawrence 2 or 3)
  • Ability to participate in examinations
  • Ability to participate in exercise sessions
  • 20≤ Body Mass Index (BMI) ≤35 kg/m2
  • Ability to comply with rules about concomitant medication and therapy
  • Speak, read and write Danish

Exclusion Criteria:

  • Participation in exercise training for the knee osteoarthritis within 3 months of enrollment
  • Counterindications for exercise
  • Pregnant or breastfeeding
  • Current or previous autoimmune disease
  • History of surgical joint replacement in the lower limbs
  • Planned surgery
  • Current or previous diagnosis or signs of cardiovascular disease
  • Neurological disorders
  • Alcohol or drug abuse
  • Diabetes
  • Psychiatric disorders
  • Regional pain syndromes
  • Regional pain caused by lumbar or cervical nerve root compression
  • Counterindications to MR scan
  • Counterindications to MR contrast

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01545258

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The Parker Institute, Dept of rheumatology, Frederiksberg hospital
Copenhagen, Denmark, 2000 F
Sponsors and Collaborators
Frederiksberg University Hospital
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Principal Investigator: Marius Henriksen, PhD The Parker Institute, Frederiksberg Hospital
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Marius Henriksen, Senior researcher, Frederiksberg University Hospital Identifier: NCT01545258    
Other Study ID Numbers: PI101.03
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases