Exercise and Pain Sensitivity in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545258
• Other study ID #: PI101.03
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: December 1, 2016
• Start date: March 2012

Study information

• Verified date: December 2016
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exercise
Physiotherapy supervised exercise training. 60 minutes 3 times per week

Locations

Country	Name	City	State
Denmark	The Parker Institute, Dept of rheumatology, Frederiksberg hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mechanical pain sensitivity	Pain thresholds and temporal summation of pain	Baseline and at 12 weeks	No
Secondary	Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine		Baseline and at 12 weeks	No
Secondary	Change from baseline in patient reported pain and function	KOOS questionnaire	Baseline and at 12 weeks	No
Secondary	Change from baseline in functional pain test	Pain is assessed during continuous tradmill walking at self-selected pace for 20 minutes.	Baseline and at 12 weeks	No
Secondary	Change from baseline in imaged based quantification of inflammation in the knee	Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)	Baseline and at 12 weeks	No

External Links

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