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

August 1, 2016 updated by: Brian Clausen, University of Southern Denmark

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5230
        • University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
  • Functional
  • Stability
  • Alignment
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:
  • Diclofenac
  • Acetaminophen
  • Ibuprofen
  • Celecoxib
  • Acetylsalicylic acid
  • Nabumetone
  • Meloxicam
  • Indomethacin
  • Etodolac
  • Naproxen
  • Etoricoxib
  • Non-Steroid Anti-Inflamatoric Drug:
  • Dexibuprofen
  • Lornoxicam
  • Tenoxicam
  • Tiaprofenic acid
  • Dexketoprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and post intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in 1st peak Knee adduction moment
Time Frame: Baseline and post intervention (8 weeks)
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)
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
Baseline and post intervention (8 weeks)
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
Baseline and post intervention (8 weeks)
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
Baseline and post intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20110153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Neuromuscular exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe