Patient Response to Spinal Manipulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation
研究概览
简要总结
This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological and patient self-report outcome variables. In addition, as there is little quantitative information on Spinal Manipulation Technique procedures reported in clinical trials, the study is designed to collect preliminary kinetic measures of the spinal manipulation technique delivery (i.e. force-time profiles).
详细描述
Participants with narrowly defined chronic low back pain will be included in this study. Each participant will be treated 12 times over the course of 6 weeks. The following data will be collected: participant characteristics that may predict outcome or be modifiers of force used by provider (gender, age, height, weight, and Body Mass Index); spinal segment load during the pre-load and thrusting phases (force and moment in the pre-load phase, peak load, and loading rate); physiological measures (posterior-anterior global stiffness and flexion-relaxation); patient-centered outcomes of back pain and function; and adverse events.
Study participants (n= 80) will be recruited from the Quad Cities metro area. A team of experienced chiropractic clinicians working at the Palmer Center for Chiropractic Research will treat study participants. Each of the study participants will receive 2 High Velocity Low Amplitude Spinal Manipulation treatment visits per week over a 6 week period. The physiological assessments will be performed immediately before and after Spinal Manipulation delivery during treatment visits 1, 5 & 12 (6 sets of assessments in total). During these same treatment visits, we will also capture the kinetic measures during Spinal Manipulation delivery for spinal segment load analysis. Participant patient-centered outcomes will be measured at baseline 1, and treatment visits 6 and 13. For simplicity, data collection time points will be named as baseline, after 2 weeks, and after 6 weeks.
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
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NRS score, AVERAGE within the past 24 hours
- •Must be ≥4 at the phone screen or baseline 1 visit
- •Must be ≥2 at phone screen, baseline 1 and baseline 2 visits
- •Roland Morris Disability ≥6
- •Age 21-65
- •Signed informed consent document
- •Chronic (12+ weeks) low back pain
排除标准
- •Compliance concerns
- •No manipulable lesion in L1-L5 or SI joints
- •The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings
- •Ongoing treatment for low back pain by outside provider
- •Comorbid conditions
- •Serious concomitant illness
- •Inflammatory or destructive spinal tissue change
- •Ankylosing Spondylytis
- •Fibromyalgia
- •Rheumatoid Arthritis
- •Confirmed or suspected disc herniation with neurological signs
- •Neuromuscular disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis
- •Spinal surgery <6 months
- •Suspicion of drug or alcohol dependence or abuse
- •Uncontrolled hypertension
- •Lower extremity peripheral arterial disease
- •Undetermined, infections or visceral source of low back pain
- •Other comorbid conditions prohibiting treatment and/or testing
- •Safety concerns
- •Bleeding disorders
- •Contraindications to High Velocity Low Amplitude Spinal Manipulation
- •Inability to tolerate or obtain positon for flexion-relaxation test without condition aggravation
- •Inability to tolerate or perform/receive any study procedure without condition aggravation
- •Quebec Task Force (QTF) criterion 4-11:
- •QTF 4: Pain + radiation to upper/lower limb with neurologic signs
- •QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram
- •QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques
- •QTF 7: Spinal Stenosis
- •QTF 8: Postsurgical status, 1-6 months after intervention
- •QTF 9: Postsurgical status, >6 months after intervention
- •QTF 10: Chronic pain syndrome
- •QTF 11: Other diagnoses
- •Pregnancy
- •Pacemaker or defibrillator
- •Inability to read or verbally comprehend English
- •Joint replacement
- •Use of spinal manipulation within past 4 weeks
- •Sensitivity to adhesive
- •Diagnostic procedures other than x-ray/UA necessary
- •BDI-II ≥29
- •Retention of legal advice and open or pending case related to low back pain
- •Unwilling to have low back and wrist shaved
- •Moving from Quad Cities area within next 8 weeks
- •Unwilling to postpone treatments for low back pain from another provider
- •Seeking or receiving compensation for any disability
结局指标
主要结局
Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation
时间窗: Baseline, 2 weeks, 6 weeks
LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless). LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal.
Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)
时间窗: Baseline to 6 weeks
VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant. RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant.
Flexion-Relaxation Ratio (FRR)
时间窗: Baseline, 2 weeks, 6 weeks
FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.
Lumbar-spine Stiffness (LSS)
时间窗: Baseline, 2 weeks, 6 weeks
LSS\* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device \& 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation \& 5) a hand-held device. \*LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.
次要结局
- Kinetic Measure - Spinal Segment Load (SSL) Force(6 weeks)
- Kinetic Measure - Spinal Segment Load (SSL) Moment(6 weeks)
- Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force(6 weeks)
- Bothersomeness(Baseline, 2 weeks, 6 weeks)
- Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment(6 weeks)
- PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale(Baseline, 2 weeks, 6 weeks)
- PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS(Baseline, 2 weeks, 6 weeks)