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Completed

NCT Number: NCT01638962

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

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.

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Key information

Conditions

Osteoarthritis, Knee Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark

Odense, Region Syddanmark, 5230, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)

Drug

The PHARMA group receives instruction, by video and pamphlet, on how to best use acetaminophen and NSAID as pain management for knee OA.

Other names: Acetaminophen, Non-Steroid Anti-Inflamatoric Drug:, Ibuprofen, Acetylsalicylic acid, Celecoxib, Dexibuprofen, Etoricoxib, Lornoxicam, Meloxicam, Diclofenac, Etodolac, Indomethacin, Nabumetone, Naproxen, Tenoxicam, Tiaprofenic acid, Dexketoprofen

Neuromuscular Exercise

Other

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.

Other names: Exercise, Stability, Alignment, Functional

Primary outcomes

  1. 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 outcomes

  1. Change from baseline in 1st peak Knee adduction moment

    Time frame: Baseline and post intervention (8 weeks)

  2. Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire

    Time frame: Baseline and post intervention (8 weeks)

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Association of Danish Physiotherapists
  • Odense University Hospital
  • Region Syddanmark
  • The Danish Rheumatism Association

Registry information

Official study 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

Acronym: EXERPHARMA

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 12, 2012
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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