Strongest Predictors of a Positive Outcome After Physiotherapy for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Which Factors Are the Strongest Predictors of a Positive Outcome After Physiotherapy for Patients With Knee Osteoarthritis?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03113149
• Other study ID #: 2016/984-1
• Status: Terminated
• Phase: N/A
• First received: April 4, 2017
• Last updated: November 21, 2017
• Start date: May 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Individuals with painful knee osteoarthritis (OA) experience restricted physical function. Few previous studies have investigated comprehensive sets of constructs and tests to investigate physical function in these patients. Most single studies of knee OA patients show limited scope for explaining physical function in the perspective of WHO's International Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the bodily level), Activities (individual level), and Participation (societal level). On the bodily level there is limited case-control knowledge on muscle strength beyond the knee and endurance-strength in general. On the activity level, there is similar limitation of biomechanical bodily features in stair climbing. On the participation level the situation is similar for objective performance. Measures are needed that inter-relate all three levels of ICF. These should also include well discriminating tests e.g. knee strength, walking, and activities of daily life (ADL), as well as both objective and subjective measures.

The purpose of this study is to explore mechanisms that can explain physical function in patients with knee OA in primary care. The study's main and primary goal is to quantify which baseline factors and change scores are the strongest predictors of a positive treatment outcome in terms of patients' global perceived change after physiotherapy. Secondary research question is: which factors are the strongest predictors of a positive outcome of physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and function in daily living?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.

2. Symptomatic daily during the last month.

3. Symptomatic for more than one year.

4. Able to walk up and down a flight of 10 stairs with or without walking aids.

5. Able to walk 3 stairs up and down without walking aids.

6. Understand Norwegian orally and in writing.

7. Body mass index below 35.

Exclusion Criteria:

1. Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain.

2. Body mass index above or equal to 35.

3. Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.

4. Chronic generalized pain (American College of Rheumatology Criteria, 2010).

5. Inability to understand Norwegian language.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Norway	Department of Neuromedicine and Movement Science, NTNU	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Diakonhjemmet Hospital, University Hospital, Umeå

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient global perceived effect	patient global perceived effect scale (Dworkin 2005, Evans 2014)	Change from baseline 'patient global perceived effect' at 3 months
Secondary	Patient Specific Functional Scale	Patient Specific Functional Scale (Stratford, 1995)	Change from baseline 'Patient Specific Functional Scale' at 3 months
Secondary	Pain intensity	Pain Intensity scale (Dworkin 2005)	Change from baseline 'Pain intensity' at 3 months
Secondary	Function of daily living	Function of daily living scale (KOOS) (Roos & Lohmander 2003)	Change from baseline 'Function of daily living' at 3 months