CClinicalTrials.gg
CompletedNCT01638962EXERPHARMAUpdated Aug 3, 2016

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

An interventional study of Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) and Neuromuscular exercise in Osteoarthritis, Knee, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-03.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Exercise Therapy
  • Gait
  • Joint load
  • Knee Joint
  • Middle Aged
  • Osteoarthritis, Knee/therapy
  • Pain Management
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 93 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    NEMEX

    NEuroMuscular EXercise

    Other: Neuromuscular exercise

  • Active comparator
    PHARMA

    PHARMAcological pain relief

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

Interventions

  • DrugInstruction 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.

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

  • OtherNeuromuscular 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.

    Also known as: Exercise, Stability, Alignment, Functional

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and post intervention (8 weeks)

Secondary outcomes

  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

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

    Time frame: Baseline and post intervention (8 weeks)

  4. 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

    Time frame: Baseline and post intervention (8 weeks)

  5. 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

    Time frame: Baseline and post intervention (8 weeks)

07

Study locations

1 site
  • University of Southern Denmark
    Odense, Region Syddanmark 5230, Denmark
08

References and documents

Publications

  • Thorstensson CA, Henriksson M, von Porat A, Sjodahl C, Roos EM. The effect of eight weeks of exercise on knee adduction moment in early knee osteoarthritis--a pilot study. Osteoarthritis Cartilage. 2007 Oct;15(10):1163-70. doi: 10.1016/j.joca.2007.03.012. Epub 2007 Apr 26. PubMed 17466541 ↗
  • Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126. PubMed 20565735 ↗
  • Holsgaard-Larsen A, Christensen R, Clausen B, Sondergaard J, Andriacchi TP, Roos EM. One year effectiveness of neuromuscular exercise compared with instruction in analgesic use on knee function in patients with early knee osteoarthritis: the EXERPHARMA randomized trial. Osteoarthritis Cartilage. 2018 Jan;26(1):28-33. doi: 10.1016/j.joca.2017.10.015. Epub 2017 Oct 26. PubMed 29107059 ↗
  • Holsgaard-Larsen A, Clausen B, Sondergaard J, Christensen R, Andriacchi TP, Roos EM. The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial. Osteoarthritis Cartilage. 2017 Apr;25(4):470-480. doi: 10.1016/j.joca.2016.10.022. Epub 2016 Nov 9. PubMed 27836677 ↗
  • Clausen B, Holsgaard-Larsen A, Sondergaard J, Christensen R, Andriacchi TP, Roos EM. The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial). Trials. 2014 Nov 15;15:444. doi: 10.1186/1745-6215-15-444. PubMed 25399048 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01638962
Lead sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Region Syddanmark, The Danish Rheumatism Association, Association of Danish Physiotherapists
Responsible party
Brian Clausen (PT, PhD-student, University of Southern Denmark) — Principal investigator
First posted
Jul 12, 2012
Start date
Aug 2012
Primary completion
Aug 2015
Completion
Jul 2016
Last update
Aug 3, 2016

Study contacts

Brian Clausen, PT, M.Sc.
principal investigator · Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Ewa M. Roos, Professor
study chair · Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion