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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01638962
Acronym
EXERPHARMA
Enrollment
93
Registered
2012-07-12
Start date
2012-08-31
Completion date
2016-07-31
Last updated
2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

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

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.

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.

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.

Sponsors

Odense University Hospital
CollaboratorOTHER
Region Syddanmark
CollaboratorOTHER
The Danish Rheumatism Association
CollaboratorOTHER
Association of Danish Physiotherapists
CollaboratorOTHER
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
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

* 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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaireBaseline and post intervention (8 weeks)
Change from baseline in 1st peak Knee adduction momentBaseline and post intervention (8 weeks)
Change from baseline in Maximum number of one-leg rises from stool testBaseline and post intervention (8 weeks)This test evaluates maximal performance and muscle strength in the lower extremity
Change from baseline in Maximum number of knee-bendings in 30s testBaseline and post intervention (8 weeks)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 testBaseline and post intervention (8 weeks)The test mimics sporting activities and demands muscle explosivety, balance and functional stability of the knee

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026