NCT03062293Unknown不适用
Newcastle Low Back Pain Intervention Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 主要终点
- Change in Intramuscular EMG of Lumbo-pelvic muscles
研究概览
简要总结
The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60.
详细描述
The aim of this study is to investigate whether an six-week FRED exercise intervention reduces low back pain (LBP) and improves a range of related outcomes.
The objectives of this study are to examine
- whether FRED exercise reduces mechanical LBP ( low back pain);
- whether FRED exercise improves functional and static balance in people with LBP;
- whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles;
- whether FRED exercise has an effect on TrA (Transversus Abdominis), LM ( Lumbar Multifidus), lumbar Erector Spinae, External and Internal Oblique muscle activity and function in individuals with LBP;
- whether FRED exercise has an effect on TrA and internal oblique muscle thickness;
- the rate of muscle physiology change in response to FRED exercise in people with LBP;
- whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP;
- whether FRED exercise affects wellbeing and every-day function in people with LBP;
- the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Ultrasound image time points are blinded to the assessor by a party not involved in the study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical LBP for 8 weeks or longer
- •Score of < 15 on FABQ
- •Age 18-60
- •Commitment to taking part in the study for its full duration
排除标准
- •Presence of "red flags" - indicative of non-mechanical LBP
- •Score of > 15 on FABQ or other indicators of a likely poor response to a solely physical approach to treatment incl. seeking compensation for LBP
- •Exercise contraindicated as per Physical Activity Readiness Questionnaire
- •Inability to exercise safely on the FRED
- •Pregnancy
- •Surgery within the previous nine months
- •Difficulty to exercise safely in standing for 30 mins 3x/week
- •Cardio/respiratory disease
- •Neurological disorders
- •BMI > 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement
结局指标
主要结局
Change in Intramuscular EMG of Lumbo-pelvic muscles
时间窗: within 1 week prior to intervention, and within 1 week post intervention (2 data collection
iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks
次要结局
- SF-36 II .(At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections))
- Change in muscular arcitecture via Ultrasound imaging(At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, 1 x week during intervention, and at intervention +12 weeks (10 data collections))
- Participant Activity Log(Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days))
- VICON/ force plate kinematic data(within 1 week prior to intervention and and within 1 week post intervention (2 data collections))
- Patient Specific Functional Scale(At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections))
- Numeric Rating Scale for Pain(At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections))
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