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

Osteoarthritis, Knee Clinical Trial

— EXERPHARMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638962
• Other study ID #: S-20110153
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: August 1, 2016
• Start date: August 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical 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 difference in knee joint load, and the exercise group will have a reduction in knee joint load.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Region Syddanmark

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Association of Danish Physiotherapists, Odense University Hospital, Region Syddanmark, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

Thorstensson CA, Henriksson M, von Porat A, Sjödahl 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. Epub 2007 Apr 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 = v(Kflex. moment2 + Kadd. moment2 + Kint.rot. moment2 )/3	Baseline and post intervention (8 weeks)	No
Secondary	Change from baseline in 1st peak Knee adduction moment		Baseline and post intervention (8 weeks)	No
Secondary	Change from baseline in the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire		Baseline and post intervention (8 weeks)	No
Secondary	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	Baseline and post intervention (8 weeks)	No
Secondary	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	Baseline and post intervention (8 weeks)	No
Secondary	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	Baseline and post intervention (8 weeks)	No