Exercise and Pain Sensitivity in Knee Osteoarthritis

NCT ID: NCT01545258

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Physiotherapy supervised exercise training. 60 minutes 3 times per week

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Physiotherapy supervised exercise training. 60 minutes 3 times per week

Intervention Type OTHER

Other Intervention Names

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Exercise training

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marius Henriksen

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marius Henriksen, PhD

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute, Frederiksberg Hospital

Locations

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The Parker Institute, Dept of rheumatology, Frederiksberg hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33453514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31656173 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28879038 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27681448 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24905427 (View on PubMed)

Related Links

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Other Identifiers

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PI101.03

Identifier Type: -

Identifier Source: org_study_id

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