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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2015

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: NEMEX
    • NEuroMuscular EXercise
  • Active Comparator: PHARMA
    • PHARMAcological pain relief

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Southern Denmark
  • Collaborator
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brian Clausen, PT, PhD-student – University of Southern Denmark
  • Overall Official(s)
    • Brian Clausen, PT, M.Sc., Principal Investigator, Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
    • Ewa M. Roos, Professor, Study Chair, Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

References

Thorstensson CA, Henriksson M, von Porat A, Sjödahl C, Roos EM. The effect of eight weeks of exercise on knee adduction moment in early knee osteoarthritis–a pilot study. Osteoarthritis Cartilage. 2007 Oct;15(10):1163-70. Epub 2007 Apr 26.

Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.

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