The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
The purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians.
详细描述
The aim of the CPR is to identify patients with LBP who are likely to benefit from IMDN. Improvement of patient-reported outcomes and clinical measures of pain are the outcomes being predicted by the model. The CPR will be developed in a double-phase design. The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. This design will establish if improvement of patient reported outcomes and clinical measures of pain are achieved because of the IMDN treatment. Furthermore, each group will receive the same type and volume of lumbar and hip stretching exercises in conjunction with their assigned needling regimen. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
After the physical examination has been performed, each participant will be randomized to receive IMDN or SIMDN. Randomization will be completed by use of a computer-generated list of random numbers that will designate group assignment. The PI will inform the study PTs of the participants group assignment. The list will be maintained by a research assistant who is not involved with participant recruitment, examination or treatment. Participants will be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the ages of 18 and 60 years with non-traumatic low back pain between the 12th rib and the buttock region.
- •Participants must also report an Oswestry Disability Index score of at least 20/100 points.
排除标准
- •Participants must be able to speak and read English.
- •Individuals who are currently pregnant, currently taking pain narcotic medication or have had a prior surgery in the lumbosacral spine
- •Those participants whose BMI is greater than 35
结局指标
主要结局
Oswestry Disability Index
时间窗: Baseline, week 1, week 2 and week 3
self reported questionnaire that is used to measure a patient's permanent functional disability.
次要结局
- Fear-Avoidance Beliefs Questionnaire(Baseline, week 1, week 2 and week 3)
- 11 point Numeric Pain-Rating Scale(Baseline, week 1, week 2 and week 3)
研究者
Dominic Severino
Assistant Professor
Whitworth University