The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT
NCT ID: NCT01638962
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2012-08-31
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NEMEX
NEuroMuscular EXercise
Neuromuscular 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.
PHARMA
PHARMAcological pain relief
Instruction 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.
Interventions
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Instruction 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.
Neuromuscular 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
40 Years
70 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Region Syddanmark
OTHER
The Danish Rheumatism Association
OTHER
Association of Danish Physiotherapists
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Brian Clausen
PT, PhD-student
Principal Investigators
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Brian Clausen, PT, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Ewa M. Roos, Professor
Role: STUDY_CHAIR
Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Locations
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University of Southern Denmark
Odense, Region Syddanmark, Denmark
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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S-20110153
Identifier Type: -
Identifier Source: org_study_id
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