Clinical trial NCT01638962: The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT
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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Exercise Therapy
Gait
Joint load
Knee Joint
Middle Aged
Osteoarthritis, Knee/therapy
Pain Management
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Region Syddanmark
name: The Danish Rheumatism Association
name: Association of Danish Physiotherapists
First posted: 2012-07-12
Enrollment: 93
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in 1st peak RMS (root mean square) Knee Index.
timeFrame: Baseline and post intervention (8 weeks)
Secondary outcomes:
measure: Change from baseline in 1st peak Knee adduction moment
timeFrame: Baseline and post intervention (8 weeks)
measure: Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire
timeFrame: Baseline and post intervention (8 weeks)
measure: Change from baseline in Maximum number of one-leg rises from stool test
timeFrame: Baseline and post intervention (8 weeks)
measure: Change from baseline in Maximum number of knee-bendings in 30s test
timeFrame: Baseline and post intervention (8 weeks)
measure: Change from baseline in One-leg hop for distance test
timeFrame: Baseline and post intervention (8 weeks)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Region Syddanmark
Study officials:
affiliation: Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Brian Clausen, PT, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Ewa M. Roos, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.