Exercise and Pain Sensitivity in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Exercise

• Registration Number: NCT01545258
• Lead Sponsor: Frederiksberg University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2013-03
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in mechanical pain sensitivity	Baseline and at 12 weeks	Pain thresholds and temporal summation of pain

Secondary Outcome Measures

Name	Time	Method
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	KOOS questionnaire
Change from baseline in functional pain test	Baseline and at 12 weeks	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	Baseline and at 12 weeks	Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)

Trial Locations

Locations (1)

The Parker Institute, Dept of rheumatology, Frederiksberg hospital; 🇩🇰 Copenhagen, Denmark