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Completed

NCT Number: NCT01545258

Exercise and Pain Sensitivity in Knee Osteoarthritis

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Dept of rheumatology, Frederiksberg hospital

Copenhagen, 2000 F, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Physiotherapy supervised exercise training. 60 minutes 3 times per week

Other names: Exercise training

Primary outcomes

  1. Change from baseline in mechanical pain sensitivity

    Time frame: Baseline and at 12 weeks

    Pain thresholds and temporal summation of pain

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Registry information

Official study title

Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis

Important dates

Study start
2012
Primary completion
2013
First posted
Mar 6, 2012
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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