跳至主要内容
临床试验/CTRI/2022/06/043209
CTRI/2022/06/043209招募中不适用

Effectiveness of Dynamic Neuromuscular Stabilization Exercises in Patients of Non- Specific Chronic Low Back Pain with Movement Control Impairment

Manju Kaushik1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年6月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
1. Lumbar Segmental Motion

研究概览

简要总结

This study will examine and compare the therapeutic outcomes of Dynamic Neuromuscular Stabilization (DNS) with Strengthening and Flexibility Exercises (SFE) in patients with Non-Specific Chronic Low Back Pain (NSCLBP) with Movement Control Impairment (MCI).

The intended study is an assessor-blinded, experimental, randomized controlled trial with two parallel arms and two measurement points: baseline assessment and at the end of the six-week intervention or after the conclusion of 30 sessions of intervention. A total of 66 subjects having non-specific chronic low back pain will be chosen based on inclusion criteria and randomly assigned to one of the two groups (33 subjects in each group). Outcome variables will include lumbar segmental stability (sagittal plane inter-vertebral rotations and translations), lumbo-pelvic dynamic stability, trunk endurance, proprioception, pain, disability, kinesiophobia and quality of life. Both groups will receive progressive group-specific exercises. Group A will receive DNS Exercises and Group B will receive generally prescribed strengthening and flexibility exercises (SFE) for 30-45 minutes per session. Altogether, participants will have maximum 5 sessions of supervised training in a week for a total of 6 weeks (30 sessions).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Numeric Pain Rating Scale (NPRS) of 2 or more
  • Positive prone instability test
  • Two or more positive test findings on Luomajoki MCI tests battery as 
well as MCI specific complaints of pain elicitation in static postures
  • Score of 20% or more on Oswestry Disability Index version 2.1a (ODI v 2.1a).

排除标准

  • Back discomfort caused by a specific pathology, such as a disc herniation, tumour, infection, or fracture, osteoporosis, structural deformity, inflammatory illness, radicular syndrome, or cauda equina syndrome
  • Lower Back pain that is constant or severe, as determined by clinical criteria, due to nerve root irritation 

  • Any Spinal surgery or Major surgery within the past years 

  • Current Pregnancy or post partum period less than 6 months and a multiparous woman who 
has given birth more than twice

  • BMI ≥ 30 Or Presence of co-morbidity (e.g. history of angina, shortness of breath, 
uncontrolled hypertension), which may limit exercise performance.
  • Straight Leg 
Raise (SLR) less than 50° Or positive sacroiliac-joint pain provocation tests 

  • Patients with a score of ≥ 72 on the Örebro Musculoskeletal Screening Questionnaire -12 (OMSQ-12) will be excluded to avoid confounding by psychosocial factors.

结局指标

主要结局

1. Lumbar Segmental Motion

时间窗: Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions

2. Lumbo-Pelvic Dynamic Stability 


时间窗: Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions

3. Trunk Endurance

时间窗: Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions

4. Proprioception 


时间窗: Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions

次要结局

  • Kinesiophobia 
(Fear of Movement)(Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions)
  • Quality of life 
(Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions)
  • Pain 

  • Functional Disability 
(Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions)

研究者

发起方
Manju Kaushik
申办方类型
Other [self]

研究点 (1)

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