The Effect on Knee Joint Loads of Instruction in Analgesic Use Compared With NEUROMUSCULAR Exercise in Patients With Knee Osteoarthritis - A Single Blind RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Change from baseline in 1st peak RMS (root mean square) Knee Index.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NEMEX
NEuroMuscular EXercise
干预措施: Neuromuscular exercise (Other)
PHARMA
PHARMAcological pain relief
干预措施: Instruction on analgesic use for pain relief (acetaminophen and NSAIDs) (Drug)
结局指标
主要结局
Change from baseline in 1st peak RMS (root mean square) Knee Index.
时间窗: 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
次要结局
- 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))
研究者
Brian Clausen
PT, PhD-student
University of Southern Denmark