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Osteoarthritis, KneeEXERPHARMANCT01638962

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

A study testing Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) and Neuromuscular exercise in people with Osteoarthritis, Knee, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) and Neuromuscular exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteDenmark
Study dates
Aug 2012to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Southern Denmark

    Odense, Region Syddanmark, 5230

Other trials in Denmark

About this study

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

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.

Being tested
Instruction on analgesic use for pain relief (acetaminophen and NSAIDs), Neuromuscular exercise
Keywords
Exercise Therapy, Gait, Joint load, Knee Joint, Middle Aged, Osteoarthritis, Knee/therapy, Pain Management
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Acetaminophen, Non-Steroid Anti-Inflamatoric Drug:, Ibuprofen, Acetylsalicylic acid

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

  • Neuromuscular exerciseOther

    Also called Exercise, Stability, Alignment, Functional

    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.

Study groups in NCT01638962
Study groupRoleWhat they receive
NEMEXExperimentalNEuroMuscular EXercise
Receives: Other: Neuromuscular exercise
PHARMAActive comparatorPHARMAcological pain relief
Receives: Drug: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and post intervention (8 weeks)

Secondary outcomes (5)

  1. Change from baseline in 1st peak Knee adduction moment

    Measured: Baseline and post intervention (8 weeks)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline and post intervention (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2015
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01638962
Sponsor's protocol ID
S-20110153
Acronym
EXERPHARMA
Status last verified
Aug 2016
First submitted
3 Jul 2012
Last updated
3 Aug 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) and Neuromuscular exercise in people with Osteoarthritis, Knee, run by University of Southern Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in 1st peak RMS (root mean square) Knee Index. (time frame: Baseline and post intervention (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01638962, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.

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