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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Southern Denmark
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
ClinicalTrials.gov Identifier:
NCT01638962
First received: July 3, 2012
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention
Osteoarthritis, Knee
Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)
Other: Neuromuscular exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change from baseline in 1st peak RMS (root mean square) Knee Index. [ Time Frame: Baseline and post intervention (8 weeks) ] [ Designated as safety issue: No ]

    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:
  • Change from baseline in 1st peak Knee adduction moment [ Time Frame: Baseline and post intervention (8 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire [ Time Frame: Baseline and post intervention (8 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in Maximum number of one-leg rises from stool test [ Time Frame: Baseline and post intervention (8 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The test mimics sporting activities and demands muscle explosivety, balance and functional stability of the knee


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638962

Contacts
Contact: Brian Clausen, M.Sc. 0045 6550 3736 brclausen@health.sdu.dk
Contact: Ewa M Roos, PhD 0045 6550 4331 eroos@health.sdu.dk

Locations
Denmark
University of Southern Denmark Recruiting
Odense, Region Syddanmark, Denmark, 5230
Contact: Brian Clausen, PT, M.Sc.    0045 6550 3736    brclausen@health.sdu.dk   
Principal Investigator: Brian Clausen, PhD-fellow         
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Region Syddanmark
The Danish Rheumatism Association
Association of Danish Physiotherapists
Investigators
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

Publications:
Responsible Party: Brian Clausen, PT, PhD-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01638962     History of Changes
Other Study ID Numbers: S-20110153
Study First Received: July 3, 2012
Last Updated: June 16, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by University of Southern Denmark:
Exercise Therapy
Gait
Joint load
Knee Joint
Middle Aged
Osteoarthritis, Knee/therapy
Pain Management

Additional relevant MeSH terms:
Analgesics
Analgesics, Non-Narcotic
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014