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

NCT01638962 | Completed

• 1 other identifier: S-20110153
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

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

  Baseline and post intervention (8 weeks)

Secondary Outcomes (5)

• Change from baseline in 1st peak Knee adduction moment

  Baseline and post intervention (8 weeks)

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

  Baseline and post intervention (8 weeks)

• Change from baseline in Maximum number of one-leg rises from stool test

  Baseline and post intervention (8 weeks)

• Change from baseline in Maximum number of knee-bendings in 30s test

  Baseline and post intervention (8 weeks)

• Change from baseline in One-leg hop for distance test

  Baseline and post intervention (8 weeks)

Study Arms (2)

NEMEX

EXPERIMENTAL

NEuroMuscular EXercise

Other: Neuromuscular exercise

PHARMA

ACTIVE COMPARATOR

PHARMAcological pain relief

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

Interventions

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

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

PHARMA

Neuromuscular exercise OTHER

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

NEMEX

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Region Syddanmark: collaborator
• The Danish Rheumatism Association: collaborator
• Association of Danish Physiotherapists: collaborator

Study Sites (1)

University of Southern Denmark

Odense, Region Syddanmark, 5230, Denmark

Location

Related Publications (5)

• 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.

  PMID: 17466541 BACKGROUND

• 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.

  PMID: 20565735 BACKGROUND

• 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.

  PMID: 29107059 DERIVED

• 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.

  PMID: 27836677 DERIVED

• 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.

  PMID: 25399048 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Agnosia

Interventions

Analgesia; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Aspirin; Celecoxib; dexibuprofen; Etoricoxib; lornoxicam; Meloxicam; Diclofenac; Etodolac; Indomethacin; Nabumetone; Naproxen; tenoxicam; tiaprofenic acid; dexketoprofen trometamol; Muscle Stretching Exercises; Exercise; Functional Status

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzenesulfonamides; Sulfonamides; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Thiazines; Thiazoles; Phenylacetates; Indoleacetic Acids; Acids, Heterocyclic; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Butanones; Ketones; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Activities of Daily Living; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Brian Clausen, PT, M.Sc.

  Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Ewa M. Roos, Professor

  Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD-student

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 12, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: July 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

DK (1)