Pain Sensitization and Outcome Following Physiotherapy in Patients With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02310945|
Recruitment Status : Unknown
Verified December 2014 by University College Dublin.
Recruitment status was: Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Pain is the dominant symptom of knee osteoarthritis and recent evidence suggests factors outside of local joint pathology, such as pain sensitization, can contribute significantly to the pain experience. It is unknown how pain sensitization influences outcomes from commonly employed interventions such as physiotherapy.
The aims of this study are, firstly to identify people with knee OA who display signs and symptoms associated with pain sensitization using clinical tools and quantitative sensory testing. Secondly, we will investigate if indications of pain sensitization at baseline are associated with poor outcome following physiotherapy.
Methods and analysis:
This is a multi-centre prospective cohort study with 140 participants. Eligible patients with moderate/severe symptomatic knee osteoarthritis will be identified at hospital outpatient clinics. A baseline assessment will provide a comprehensive description of the somatosensory characteristics of each participant by means of clinical examination, quantitative sensory testing and validated questionnaires measuring pain and functional capacity. Participants will then undergo physiotherapy treatment, in line with current clinical guidelines. Follow-up post physiotherapy treatment (estimated to be at 3 months) will assess pain, disability (sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index) and participants' global rating of change. These primary outcome measures will dichotomise participants into treatment 'responders' and 'non-responders' according to the Osteoarthritis Research Society International (OARSI) treatment responder criteria.
For data analysis results from pressure pain thresholds, temporal summation and conditioned pain modulation will create a composite score of pain sensitization. Logistic regression will explore the relationship between response to physiotherapy and pain sensitization at baseline while accounting for various cofounders.
|Condition or disease||Intervention/treatment|
|Knee Osteoarthritis||Other: Physiotherapy|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Pain Sensitization and the Risk of Poor Outcome Following Physiotherapy for Knee Osteoarthritis: A Protocol for a Prospective Cohort Study|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||January 2016|
People with moderate/severe symptomatic knee osteoarthritis referred for physiotherapy
Individualised programme for each patient in line with current clinical guidelines. May include education, exercise (strengthening, range of motion exercise, aerobic), lifestyle advice and manual therapy
- Change in response to physiotherapy as measured by the pain and function sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index (WOMAC) and patient's global rating of change. [ Time Frame: Baseline & at 3 months (estimated time point for physiotherapy treatment completion) ]These 3 outcome measures will gather data that will be applied to a set of treatment responder criteria by the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) to determine a positive response to physiotherapy or a 'treatment responder'
- Quantitative sensory testing (pressure pain thresholds, temporal summation, conditioned pain modulation, mechanical detection thresholds) [ Time Frame: Baseline ]To describe the somatosensory characteristics of the sample and detect features of pain sensitization
- Central Sensitization Inventory [ Time Frame: Baseline ]Questionnaire to assess for symptoms not related to the musculoskeletal system but common to central sensitization syndromes
- Modified PainDETECT [ Time Frame: Baseline ]Questionnaire that records any neuropathic component to patient's symptoms
- Centre for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline ]A measure of depressive symptoms
- Overweight/Obesity [ Time Frame: Baseline ]Measured by recording participants' waist circumference to height ratio
- Manual tender point count [ Time Frame: Baseline ]Manual tender point examination to identify tender points according to the American College of Rheumatology criteria for fibromyalgia
- EQ-5D 5L [ Time Frame: Baseline ]Questionnaire to measure health related quality of life
- Self Administered Comorbidity Questionnaire [ Time Frame: Baseline ]Questionnaire to record presence of comorbid conditions
- Widespread pain [ Time Frame: Baseline ]Widespread pain is defined according to the American College of Rheumatology classification criteria using pain drawings marked by participants on a body manikin
- Patient adherence monitored over the course of physiotherapy treatment (Sports Injury Rehabilitation Adherence Scale (SIRAS) and Home Exercise Compliance Assessment (HECA) ) [ Time Frame: Recorded at each physiotherapy appointment (approx 6 times between 0 and 3 months) ]SIRAS records physiotherapist's perceptions of patient's rehab adherence. HECA is a self-report method for patients to measure their own adherence
- Change in medication use and use of co-interventions [ Time Frame: At 3 months (estimated time point for physiotherapy treatment completion) ]Any self reported change in medications and co-interventions. Recorded at 3 months using follow-up questionnaire.
- Change in knee pain and disability at 6 months [ Time Frame: Baseline and at 6 months ]Measured with pain and disability sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index (WOMAC)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310945
|Contact: Helen O'Leary, BSc Physiofirstname.lastname@example.org|
|Contact: Catherine Doody, BSc Physio||00353 email@example.com|
|St. James's Hospital||Recruiting|
|Dublin, Ireland, 2|
|Contact: Jennie Cronin, BSc Physio 00353 14162503 JCronin@stjames.ie|
|Contact: Niamh Murphy, BSc Physio 00353 14162503 NIMurphy@stjames.ie|
|St. Vincent's University Hospital||Recruiting|
|Dublin, Ireland, 4|
|Contact: Keith Smart, BSc Physio 00353 12214467 firstname.lastname@example.org|
|Contact: McLoughlin Catherine, BSc Physio 00353 12214467 McLoughlin@st-vincents.ie|
|Principal Investigator: Helen O'Leary, BSc Physio|
|Contact: Aisling Brennan, BSc Physio 00353 14142750 email@example.com|
|Contact: Rachel Burke, BSc Physio 00353 14142750 firstname.lastname@example.org|
|Principal Investigator:||Helen O'Leary, BSc Physio||University College Dublin|
|Study Director:||Catherine Doody, BSc Physio||University College Dublin|
|Study Chair:||Keith Smart, BSc Physio||St. Vincent's University Hospital|
|Study Chair:||Niamh Moloney, BSc Physio||University College Dublin|