The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT

Study Overview
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Brief Summary
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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.

Official Title
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The Effect on Knee Joint Loads of Instruction in Analgesic Use Compared With NEUROMUSCULAR Exercise in Patients With Knee Osteoarthritis - A Single Blind RCT

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)
* Other: Neuromuscular exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEMEX<br>NEuroMuscular EXercise | Other: Neuromuscular exercise<br>* 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.<br>* Other names: Functional;|
| Active Comparator: PHARMA<br>PHARMAcological pain relief | Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)<br>* The PHARMA group receives instruction, by video and pamphlet, on how to best use acetaminophen and NSAID as pain management for knee OA.<br>* Other names: Dexketoprofen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 1st peak RMS (root mean square) Knee Index. | 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 | Baseline and post intervention (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This test evaluates maximal performance and muscle strength in the lower extremity | Baseline and post intervention (8 weeks) | 
| Change from baseline in Maximum number of knee-bendings in 30s test | This test evaluates the ability to perform fast changes between eccentric and concentric muscle force over the knee joint | Baseline and post intervention (8 weeks) | 
| Change from baseline in One-leg hop for distance test | The test mimics sporting activities and demands muscle explosivety, balance and functional stability of the knee | Baseline and post intervention (8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy, Gait, Joint load, Knee Joint, Middle Aged, Osteoarthritis, Knee/therapy, Pain Management