Clinical trial NCT01945749: Exercise and Steroid in Knee Osteoarthritis
Official title: Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and disability. As no cure exists, management aims to reduce pain, improve function, and enhance quality of life. The recommended hierarchy of management should consist of exercise in first line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.

The effect size of exercise therapy is of the same magnitude as most pharmacological treatments but is often without adverse effects. Local pharmacological treatment of the afflicted knee joint is recommended by means of intra-articular injections of corticosteroids, which is considered as a standard medical treatment of knee OA and are included in established guidelines for management of knee OA. While the two treatment approaches have been investigated separately in numerous clinical trials, the efficacy of a combined pharmacological and non-pharmacological approach is not known, despite the high rank of such combined treatment approach on the recommended hierarchy of management.

The purpose of this study is to assess the effects of exercise therapy in combination with intra-articular corticosteroid injections on patient reported pain and function in patients with knee OA.

The hypothesis is that the combined treatment approach (exercise therapy preceded by intra-articular injection of corticosteroid) enhances the clinical outcome compared to exercise therapy preceded by a placebo injection.


Eligibility criteria: Inclusion Criteria:

* age 40 years or above
* clinical knee osteoarthritis verified by radiography
* pain during level walking of at least 40 mm on a 0-100 mm visual analog scale
* clinical signs of local inflammation
* body mass index between 20 and 35

Exclusion Criteria:

* Exercise therapy within 3 months
* Intraarticular corticosteroid within 3 months
* Counter indications to exercise
* Counter indications to corticosteroid
* pregnant or breast feeding
* Auto immune disease
* Planned surgery in the study period
* significant cardiovascular disease
* significant neuroloigal disease
* significant psychiatric disease
* regional pain syndromes (e.g. fibromyalgia)
* spinal nerve root compression syndromes

Primary outcomes:
measure: Knee pain
timeFrame: Change from baseline to week 14
Secondary outcomes:
measure: Knee pain
timeFrame: Change from baseline to week 2 and week 26
measure: Knee symptoms
timeFrame: Change from baseline to week 2, 14, and 26
measure: Functional pain test
timeFrame: Change from baseline to week 14, and 26
measure: Knee Muscle strength
timeFrame: Change from baseline to week 14, and 26
measure: 6 minute walk distance
timeFrame: Change from baseline to week 14, and 26
measure: Systemic markers of inflammation in blood
timeFrame: Change from baseline to week 14, and 26
measure: MRI based inflammation
timeFrame: Change from baseline to week 14, and 26
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: Frederiksberg University Hospital
name: Marius Henriksen, PhD
role: STUDY_CHAIR
References:
citation: Dall CH, Andersen H, Povlsen TM, Henriksen M. Evaluation of a technology assisted physical activity intervention among hospitalised patients: A randomised study. Eur J Intern Med. 2019 Nov;69:50-56. doi: 10.1016/j.ejim.2019.08.019. Epub 2019 Sep 4.
citation: Bartholdy C, Klokker L, Bandak E, Bliddal H, Henriksen M. A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations. J Orthop Sports Phys Ther. 2016 Nov;46(11):942-946. doi: 10.2519/jospt.2016.6908. Epub 2016 Sep 28.
citation: Henriksen M, Christensen R, Klokker L, Bartholdy C, Bandak E, Ellegaard K, Boesen MP, Riis RG, Bartels EM, Bliddal H. Evaluation of the benefit of corticosteroid injection before exercise therapy in patients with osteoarthritis of the knee: a randomized clinical trial. JAMA Intern Med. 2015 Jun;175(6):923-30. doi: 10.1001/jamainternmed.2015.0461.