Exercise and Pain Sensitivity in Knee Osteoarthritis
This study is currently recruiting participants.
Verified March 2012 by Frederiksberg University Hospital
Sponsor:
Frederiksberg University Hospital
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01545258
First received: March 1, 2012
Last updated: March 5, 2012
Last verified: March 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Knee Osteoarthritis |
Other: Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Frederiksberg University Hospital:
Primary Outcome Measures:
- Change from baseline in mechanical pain sensitivity [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]Pain thresholds and temporal summation of pain
Secondary Outcome Measures:
- Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in patient reported pain and function [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]KOOS questionnaire
- Change from baseline in functional pain test [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exercise
Exercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week.
|
Other: Exercise
Physiotherapy supervised exercise training. 60 minutes 3 times per week
Other Name: Exercise training
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545258
Contacts
| Contact: Marius Henriksen, PhD | +45338164160 | mh@frh.regionh.dk |
| Contact: Louise klokker, MSc | +4538164155 | lkm@frh.regionh.dk |
Locations
| Denmark | |
| The Parker Institute, Dept of rheumatology, Frederiksberg hospital | Recruiting |
| Copenhagen, Denmark, 2000 F | |
| Principal Investigator: Marius Henriksen, PhD | |
| Sub-Investigator: Louise Klokker, MSc | |
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
| Principal Investigator: | Marius Henriksen, PhD | The Parker Institute, Frederiksberg Hospital |
More Information
No publications provided
| Responsible Party: | Marius Henriksen, Senior researcher, Frederiksberg University Hospital |
| ClinicalTrials.gov Identifier: | NCT01545258 History of Changes |
| Other Study ID Numbers: | PI101.03 |
| Study First Received: | March 1, 2012 |
| Last Updated: | March 5, 2012 |
| Health Authority: | Denmark: The Ministry of the Interior and Health |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013