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

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ClinicalTrials.gov Identifier: NCT01638962
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : August 3, 2016
Sponsor:
Collaborators:
Odense University Hospital
Region Syddanmark
The Danish Rheumatism Association
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Brian Clausen, University of Southern Denmark

Study Description
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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.


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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NEMEX
NEuroMuscular EXercise
 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.
Other Names:
  • Exercise
  • Stability
  • Alignment
  • Functional
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.
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638962


Locations
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Denmark
University of Southern Denmark
Odense, Region Syddanmark, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Region Syddanmark
The Danish Rheumatism Association
Association of Danish Physiotherapists
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brian Clausen, PT, PhD-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01638962    
Other Study ID Numbers: S-20110153
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by Brian Clausen, University of Southern Denmark:
Exercise Therapy
Gait
Joint load
Knee Joint
 Middle Aged
Osteoarthritis, Knee/therapy
Pain Management
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Aspirin
Ibuprofen
Celecoxib
Diclofenac
Naproxen
Indomethacin
Etoricoxib
Meloxicam
 Dexketoprofen trometamol
Etodolac
Lornoxicam
Nabumetone
Tenoxicam
Tiaprofenic acid
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents