The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT
- Conditions
- Osteoarthritis, Knee
- Interventions
- Other: Neuromuscular exerciseDrug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)
- Registration Number
- NCT01638962
- Lead Sponsor
- University of Southern Denmark
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Compliance with the ACR criteria
- Medial knee OA defined as "No osteoarthritis", "Doubtful narrowing of joint space and/or possible osteophytes", "Definite osteophytes and possible narrowing of joint space", "Multiple osteophytes, definite narrowing of joint space and some sclerosis and deformity of bone ends". This corresponds to the Kellgren and Lawrence (KL) grades 0, 1, 2 and 3 respectively
- Willingness to participate in exercise and use of analgesics
- A maximum of 75/100 points in the KOOS Pain subscale
- BMI of 32 or less
- Medial greater than lateral joint space width
- Medial knee OA of KL grade 4
- Knee surgery or steroid injection within the past 6 months
- Already taking max dose NSAIDs or acetaminophen
- Any physician-determined condition that is a contraindication for use of acetaminophen, NSAIDs or to exercise
- Problems affecting the lower extremity overriding the problems from the knee
- Knee surgery planned in the next 6 months
- Known ACL tear within the past 6 months
- ACL reconstruction
- Diagnosis of systemic arthritis
- Difficulty complying with treatment schedule
- Inability to fill out questionnaires
- Inability to ambulate without an assistive device
- Ankle, knee or hip replacement
- Tibial/femoral osteotomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NEMEX Neuromuscular exercise NEuroMuscular EXercise PHARMA Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) PHARMAcological pain relief
- Primary Outcome Measures
Name Time Method Change from baseline in 1st peak RMS (root mean square) Knee Index. 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
- Secondary Outcome Measures
Name Time Method Change from baseline in 1st peak Knee adduction moment Baseline and post intervention (8 weeks) Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire Baseline and post intervention (8 weeks) Change from baseline in Maximum number of one-leg rises from stool test 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 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 Baseline and post intervention (8 weeks) The test mimics sporting activities and demands muscle explosivety, balance and functional stability of the knee
Trial Locations
- Locations (1)
University of Southern Denmark
🇩🇰Odense, Region Syddanmark, Denmark