Clinical trial NCT01545258: Exercise and Pain Sensitivity in Knee Osteoarthritis
Official title: Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Change from baseline in mechanical pain sensitivity
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
measure: Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in patient reported pain and function
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in functional pain test
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in imaged based quantification of inflammation in the knee
timeFrame: Baseline and at 12 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Dept of rheumatology, Frederiksberg hospital
Study officials:
affiliation: The Parker Institute, Frederiksberg Hospital
name: Marius Henriksen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.