Exercise and Pain Sensitivity in Knee Osteoarthritis

NCT01545258 | Completed

• 1 other identifier: PI101.03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mechanical pain sensitivity

  Pain thresholds and temporal summation of pain

  Baseline and at 12 weeks

Secondary Outcomes (4)

• Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine

  Baseline and at 12 weeks

• Change from baseline in patient reported pain and function

  Baseline and at 12 weeks

• Change from baseline in functional pain test

  Baseline and at 12 weeks

• Change from baseline in imaged based quantification of inflammation in the knee

  Baseline and at 12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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

Other: Exercise

Control

NO INTERVENTION

Interventions

Exercise OTHER

Physiotherapy supervised exercise training. 60 minutes 3 times per week

Also known as: Exercise training

Exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤ Body Mass Index (BMI) ≤35 kg/m2
• Ability to comply with rules about concomitant medication and therapy
• Speak, read and write Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Institute, Dept of rheumatology, Frederiksberg hospital

Copenhagen, 2000 F, Denmark

Location

Related Publications (5)

• 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.

  PMID: 33453514 DERIVED

• 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.

  PMID: 31656173 DERIVED

• 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.

  PMID: 28879038 DERIVED

• 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.

  PMID: 27681448 DERIVED

• 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.

  PMID: 24905427 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marius Henriksen, PhD

  The Parker Institute, Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 6, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Last Updated: December 2, 2016

Record last verified: 2016-12

Locations

DK (1)