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Exercise and Pain Sensitivity in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
Frederiksberg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Parker Institute, Dept of rheumatology, Frederiksberg hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Exercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week.

Outcomes

Primary Outcome Measures

Change from baseline in mechanical pain sensitivity
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
Change from baseline in patient reported pain and function
KOOS questionnaire
Change from baseline in functional pain test
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
Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)

Full Information

First Posted
March 1, 2012
Last Updated
December 1, 2016
Sponsor
Frederiksberg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01545258
Brief Title
Exercise and Pain Sensitivity in Knee Osteoarthritis
Official Title
Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frederiksberg University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Exercise training
Intervention Description
Physiotherapy supervised exercise training. 60 minutes 3 times per week
Primary Outcome Measure Information:
Title
Change from baseline in mechanical pain sensitivity
Description
Pain thresholds and temporal summation of pain
Time Frame
Baseline and at 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in patient reported pain and function
Description
KOOS questionnaire
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in functional pain test
Description
Pain is assessed during continuous tradmill walking at self-selected pace for 20 minutes.
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in imaged based quantification of inflammation in the knee
Description
Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)
Time Frame
Baseline and at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Henriksen, PhD
Organizational Affiliation
The Parker Institute, Frederiksberg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Institute, Dept of rheumatology, Frederiksberg hospital
City
Copenhagen
ZIP/Postal Code
2000 F
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33453514
Citation
Bandak E, Boesen M, Bliddal H, Daugaard C, Hangaard S, Bartholdy C, Damm Nybing J, Kubassova O, Henriksen M. The effect of exercise therapy on inflammatory activity assessed by MRI in knee osteoarthritis: Secondary outcomes from a randomized controlled trial. Knee. 2021 Jan;28:256-265. doi: 10.1016/j.knee.2020.12.022. Epub 2021 Jan 13.
Results Reference
derived
PubMed Identifier
31656173
Citation
Bandak E, Boesen M, Bliddal H, Riis RGC, Nielsen SM, Klokker L, Bartholdy C, Nybing JD, Henriksen M. Exercise-induced pain changes associate with changes in muscle perfusion in knee osteoarthritis: exploratory outcome analyses of a randomised controlled trial. BMC Musculoskelet Disord. 2019 Oct 27;20(1):491. doi: 10.1186/s12891-019-2858-8.
Results Reference
derived
PubMed Identifier
28879038
Citation
Henriksen M, Klokker L, Bartholdy C, Schjoedt-Jorgensen T, Bandak E, Bliddal H. No effects of functional exercise therapy on walking biomechanics in patients with knee osteoarthritis: exploratory outcome analyses from a randomised trial. BMJ Open Sport Exerc Med. 2017 Mar 27;2(1):e000230. doi: 10.1136/bmjsem-2017-000230. eCollection 2016.
Results Reference
derived
PubMed Identifier
27681448
Citation
Bartholdy C, Klokker L, Bandak E, Bliddal H, Henriksen M. A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations. J Orthop Sports Phys Ther. 2016 Nov;46(11):942-946. doi: 10.2519/jospt.2016.6908. Epub 2016 Sep 28.
Results Reference
derived
PubMed Identifier
24905427
Citation
Henriksen M, Klokker L, Graven-Nielsen T, Bartholdy C, Schjodt Jorgensen T, Bandak E, Danneskiold-Samsoe B, Christensen R, Bliddal H. Association of exercise therapy and reduction of pain sensitivity in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1836-43. doi: 10.1002/acr.22375.
Results Reference
derived
Links:
URL
http://www.parkerinst.dk
Description
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Exercise and Pain Sensitivity in Knee Osteoarthritis

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