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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

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

Neuromuscular exercise

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Exercise Therapy, Gait, Joint load, Knee Joint, Middle Aged, Osteoarthritis, Knee/therapy, Pain Management

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NEMEX

PHARMA

Arm Description

NEuroMuscular EXercise

PHARMAcological pain relief

Outcomes

Primary Outcome Measures

Change from baseline in 1st peak RMS (root mean square) Knee Index.

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

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

Change from baseline in Maximum number of one-leg rises from stool test

This test evaluates maximal performance and muscle strength in the lower extremity

Change from baseline in Maximum number of knee-bendings in 30s test

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

The test mimics sporting activities and demands muscle explosivety, balance and functional stability of the knee

Full Information

NCT ID

NCT01638962

First Posted

July 3, 2012

Last Updated

August 1, 2016

Sponsor

University of Southern Denmark

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01638962

Brief Title

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

Acronym

EXERPHARMA

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 Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern Denmark

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Exercise Therapy, Gait, Joint load, Knee Joint, Middle Aged, Osteoarthritis, Knee/therapy, Pain Management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NEMEX

Arm Type

Experimental

Arm Description

NEuroMuscular EXercise

Arm Title

PHARMA

Arm Type

Active Comparator

Arm Description

PHARMAcological pain relief

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Neuromuscular exercise

Other Intervention Name(s)

Exercise, Stability, Alignment, Functional

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in 1st peak RMS (root mean square) Knee Index.

Description

Time Frame