Exercise and Pain Sensitivity in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01545258
First received: March 1, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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 Intervention
Knee Osteoarthritis
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Change from baseline in mechanical pain sensitivity [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Pain thresholds and temporal summation of pain


Secondary Outcome Measures:
  • Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in patient reported pain and function [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    KOOS questionnaire

  • Change from baseline in functional pain test [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Pain is assessed during continuous tradmill walking at self-selected pace for 20 minutes.

  • Change from baseline in imaged based quantification of inflammation in the knee [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)


Enrollment: 60
Study Start Date: March 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01545258

Locations
Denmark
The Parker Institute, Dept of rheumatology, Frederiksberg hospital
Copenhagen, Denmark, 2000 F
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Principal Investigator: Marius Henriksen, PhD The Parker Institute, Frederiksberg Hospital
  More Information

No publications provided

Responsible Party: Marius Henriksen, Senior researcher, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01545258     History of Changes
Other Study ID Numbers: PI101.03
Study First Received: March 1, 2012
Last Updated: June 24, 2013
Health Authority: Denmark: The Ministry of the Interior and Health

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

ClinicalTrials.gov processed this record on August 28, 2014