Data

Stepped care approach for medial tibiofemoral osteoarthritis (STREAMLINE) dataset

THE UNIVERSITY OF SYDNEY

Dataset description

The full dataset includes the data of 170 participants including demographics, clinical, characteristics and outcomes at baseline, 20 and 32 weeks.
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Subjects

Rheumatology |

Related Study

Stepped Care Approach for Medial Tibiofemoral Osteoarthritis (STrEAMline)

Brief Summary

The current approach in the management of osteoarthritis is primarily palliative and is aimed at alleviating symptoms. By contrast, current literature is increasingly advocating the identification of prognostic indicators, such as muscle weakness, mal­alignment and depression that may be amenable to treatment. That is, to provide a more holistic approach to the management of osteoarthritis as well as to facilitate an improvement in an individual’s joint pain and function rather than treating every patient with a “one size fits all” approach. With this is mind, the primary aim of this pilot study is to establish whether a “stepped up”, adaptive treatment protocol can increase frequency of disease remission and improve long­term functional outcomes such as pain and stiffness among persons with medial tibiofemoral knee osteoarthritis. Participants in this pilot study will be randomized into either a control or treatment group. The treatment group will follow a diet and exercise program for 18 weeks. Reassessment of their Patient Acceptable Symptom Score (PASS) occurs at 20­week and participants who fail to reach the threshold level for disease remission based on disease symptoms and an individual’s perceived functionality will then enter into the Adaptive Treatment Protocol phase. Participants will receive additional treatment for muscle weakness, mal­alignment or depression. The control group will be provided with educational pamphlets about knee OA, largely focused on diet, exercise and weight loss. Final follow-up and assessment of disease remission will take place at 32­week. The purpose of this protocol is to develop a clinical algorithm for individualised patient treatment.

Inclusion Criteria

  • - Age 50 years and over - BMI greater than or equal to 28 - VAS pain greater than or equal to 4 out of 10 - PASS scores greater than 32.0mm for pain, 32.0mm for global assessment score and 31mm for the WOMAC questions - Knee pain and stiffness in the past 30 days - Radiographic evidence of a definite osteophyte - Radiographic evidence of disease in the medial tibiofemoral compartment -Minimum grade 1 medial tibiofemoral joint space narrowing based on the Osteoarthritis Research Society International (OARSI) atlas

Study Type

  • Interventional

Ethics Approval

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

We will share the data of 170 consented participants including demographics, clinical characteristics and outcome measures at baseline, weeks 20 and 32.

When will data be available?

After a research proposal from a secondary researcher receives a waiver of consent from the ethics committee, data will be available for an indefinite time.

Available to whom?

Researchers interested in using IPD for future studies.

Available for what types of analyses?

Any type of analyses.