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

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01638962
S-20110153

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

93 participants in 2 patient groups

NEMEX
Experimental group
Description:
NEuroMuscular EXercise
Treatment:
Other: Neuromuscular exercise
PHARMA
Active Comparator group
Description:
PHARMAcological pain relief
Treatment:
Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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