Knee Osteoarthritis Clinical Trial
Official title:
Pain Sensitization and the Risk of Poor Outcome Following Physiotherapy for Knee Osteoarthritis: A Protocol for a Prospective Cohort Study
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | January 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Knee osteoarthritis diagnosed by American College of Rheumatology clinical criteria - Knee pain must be the primary musculoskeletal complaint participant is seeking treatment for - Pain duration greater than 3 months - Pain severity = 5/10 on Numerical Rating Scale - Willing to abstain from simple analgesics and NSAIDs for 24 hours prior to testing - Willing and able to give full consent Exclusion Criteria: - Lumbar or cervical radiculopathy, - Systematic inflammatory disease, - Positive screen for diabetic neuropathy - Past medical history - Previous surgery or disease of the peripheral or central nervous system, - Sensory loss secondary to chemotherapy or radiotherapy - Fibromyalgia - Chronic fatigue syndrome - Cognitive or psychiatric disorder interfering with ability to cooperate with assessment - Injection or physiotherapy treatment for knee joint within previous 3 months - Taking anti-depressant or anti-convulsant medication |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ireland | St. James's Hospital | Dublin | |
Ireland | St. Vincent's University Hospital | Dublin | |
Ireland | Tallaght Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin | Health Research Board, Ireland |
Ireland,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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' | Baseline & at 3 months (estimated time point for physiotherapy treatment completion) | No |
Secondary | Quantitative sensory testing (pressure pain thresholds, temporal summation, conditioned pain modulation, mechanical detection thresholds) | To describe the somatosensory characteristics of the sample and detect features of pain sensitization | Baseline | No |
Secondary | Central Sensitization Inventory | Questionnaire to assess for symptoms not related to the musculoskeletal system but common to central sensitization syndromes | Baseline | No |
Secondary | Modified PainDETECT | Questionnaire that records any neuropathic component to patient's symptoms | Baseline | No |
Secondary | Centre for Epidemiologic Studies Depression Scale (CES-D) | A measure of depressive symptoms | Baseline | No |
Secondary | Overweight/Obesity | Measured by recording participants' waist circumference to height ratio | Baseline | No |
Secondary | Manual tender point count | Manual tender point examination to identify tender points according to the American College of Rheumatology criteria for fibromyalgia | Baseline | No |
Secondary | EQ-5D 5L | Questionnaire to measure health related quality of life | Baseline | No |
Secondary | Self Administered Comorbidity Questionnaire | Questionnaire to record presence of comorbid conditions | Baseline | No |
Secondary | Widespread pain | Widespread pain is defined according to the American College of Rheumatology classification criteria using pain drawings marked by participants on a body manikin | Baseline | No |
Secondary | Patient adherence monitored over the course of physiotherapy treatment (Sports Injury Rehabilitation Adherence Scale (SIRAS) and Home Exercise Compliance Assessment (HECA) ) | SIRAS records physiotherapist's perceptions of patient's rehab adherence. HECA is a self-report method for patients to measure their own adherence | Recorded at each physiotherapy appointment (approx 6 times between 0 and 3 months) | No |
Secondary | Change in medication use and use of co-interventions | Any self reported change in medications and co-interventions. Recorded at 3 months using follow-up questionnaire. | At 3 months (estimated time point for physiotherapy treatment completion) | No |
Secondary | Change in knee pain and disability at 6 months | Measured with pain and disability sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index (WOMAC) | Baseline and at 6 months | No |
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