The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT (EXERPHARMA)
|ClinicalTrials.gov Identifier: NCT01638962|
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : August 3, 2016
The purpose of this study is to compare the effects of neuromuscular exercise and analgesic use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA).
It is expected that the two groups will receive equipotent pain relieving effect, despite this, the investigators expect a between group difference in knee joint load, and the exercise group will have a reduction in knee joint load.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) Other: Neuromuscular exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect on Knee Joint Loads of Instruction in Analgesic Use Compared With NEUROMUSCULAR Exercise in Patients With Knee Osteoarthritis - A Single Blind RCT|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||July 2016|
Other: Neuromuscular exercise
The exercise group receives 1 hour of supervised neuromuscular exercise two times a week for 8 weeks. Supervision is conducted by physiotherapists specially trained in using neuromuscular exercise and its principles.
Active Comparator: PHARMA
PHARMAcological pain relief
Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)
The PHARMA group receives instruction, by video and pamphlet, on how to best use acetaminophen and NSAID as pain management for knee OA.
- Change from baseline in 1st peak RMS (root mean square) Knee Index. [ Time Frame: Baseline and post intervention (8 weeks) ]
1st peak RMS Knee Index, is combined of the moments of the 3 planes working over the the knee; flexion, adduction and internal rotation moments. Measured with the Vicon system.
1st peak RMS knee moment = √(Kflex. moment2 + Kadd. moment2 + Kint.rot. moment2 )/3
- Change from baseline in 1st peak Knee adduction moment [ Time Frame: Baseline and post intervention (8 weeks) ]
- Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire [ Time Frame: Baseline and post intervention (8 weeks) ]
- Change from baseline in Maximum number of one-leg rises from stool test [ Time Frame: Baseline and post intervention (8 weeks) ]This test evaluates maximal performance and muscle strength in the lower extremity
- Change from baseline in Maximum number of knee-bendings in 30s test [ Time Frame: Baseline and post intervention (8 weeks) ]This test evaluates the ability to perform fast changes between eccentric and concentric muscle force over the knee joint
- Change from baseline in One-leg hop for distance test [ Time Frame: Baseline and post intervention (8 weeks) ]The test mimics sporting activities and demands muscle explosivety, balance and functional stability of the knee
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638962
|University of Southern Denmark|
|Odense, Region Syddanmark, Denmark, 5230|
|Principal Investigator:||Brian Clausen, PT, M.Sc.||Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark|
|Study Chair:||Ewa M. Roos, Professor||Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark|