Exercise and Pain Sensitivity in Knee Osteoarthritis

December 1, 2016 updated by: Marius Henriksen, Frederiksberg University Hospital

Exercise and Changes in Pain Sensitivity in Patients With 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2000 F
        • The Parker Institute, Dept of rheumatology, Frederiksberg hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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 Names:
  • Exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mechanical pain sensitivity
Time Frame: Baseline and at 12 weeks
Pain thresholds and temporal summation of pain
Baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine
Time Frame: Baseline and at 12 weeks
Baseline and at 12 weeks
Change from baseline in patient reported pain and function
Time Frame: Baseline and at 12 weeks
KOOS questionnaire
Baseline and at 12 weeks
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.
Baseline and at 12 weeks
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)
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frederiksberg University Hospital

Investigators

  • Principal Investigator: Marius Henriksen, PhD, The Parker Institute, Frederiksberg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI101.03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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