Trial record 3 of 24 for:    lifestyles in osteoarthritis study

Pain Sensitization and Outcome Following Physiotherapy in Patients With Knee Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University College Dublin
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
University College Dublin
ClinicalTrials.gov Identifier:
NCT02310945
First received: November 28, 2014
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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 Intervention
Knee Osteoarthritis
Other: Physiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Sensitization and the Risk of Poor Outcome Following Physiotherapy for Knee Osteoarthritis: A Protocol for a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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'


Secondary Outcome Measures:
  • Quantitative sensory testing (pressure pain thresholds, temporal summation, conditioned pain modulation, mechanical detection thresholds) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To describe the somatosensory characteristics of the sample and detect features of pain sensitization

  • Central Sensitization Inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Questionnaire to assess for symptoms not related to the musculoskeletal system but common to central sensitization syndromes

  • Modified PainDETECT [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Questionnaire that records any neuropathic component to patient's symptoms

  • Centre for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A measure of depressive symptoms

  • Overweight/Obesity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured by recording participants' waist circumference to height ratio

  • Manual tender point count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Manual tender point examination to identify tender points according to the American College of Rheumatology criteria for fibromyalgia

  • EQ-5D 5L [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Questionnaire to measure health related quality of life

  • Self Administered Comorbidity Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Questionnaire to record presence of comorbid conditions

  • Widespread pain [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured with pain and disability sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index (WOMAC)


Estimated Enrollment: 140
Study Start Date: June 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Knee osteoarthritis
People with moderate/severe symptomatic knee osteoarthritis referred for physiotherapy
Other: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The cohort will be recruited from patients with moderate/severe symptomatic knee OA attending outpatient orthopaedic and rheumatology clinics and referred for physiotherapy treatment by a hospital consultant or clinical specialist physiotherapist.

At the time of recruitment knee pain must be the participant's primary musculoskeletal complaint they are seeking treatment for, and physiotherapy must be the main treatment being undertaken over the study period

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02310945

Contacts
Contact: Helen O'Leary, BSc Physio 353860665530 helen.oleary@ucdconnect.ie
Contact: Catherine Doody, BSc Physio 00353 17166514 c.doody@ucd.ie

Locations
Ireland
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    k.smart@st-vincents.ie   
Contact: McLoughlin Catherine, BSc Physio    00353 12214467    McLoughlin@st-vincents.ie   
Principal Investigator: Helen O'Leary, BSc Physio         
Tallaght Hospital Recruiting
Dublin, Ireland
Contact: Aisling Brennan, BSc Physio    00353 14142750    aisling.brennan@amnch.ie   
Contact: Rachel Burke, BSc Physio    00353 14142750    rachel.burke@amnch.ie   
Sponsors and Collaborators
University College Dublin
Health Research Board, Ireland
Investigators
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
  More Information

Publications:

Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT02310945     History of Changes
Other Study ID Numbers: HPF/2013/44
Study First Received: November 28, 2014
Last Updated: December 4, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Dublin:
pain
central nervous system sensitization
physiotherapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 29, 2015