Patient Response to Spinal Manipulation

Not Applicable

Completed

Conditions: Low Back Pain

Interventions: Other: HVLA-SM

Registration Number: NCT01670292

Lead Sponsor: Palmer College of Chiropractic

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

Inclusion Criteria

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

Exclusion Criteria

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
BMI ≥40
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: HVLA-SM	HVLA-SM	Experimental High Velocity Low Amplitude Spinal Manipulation

Primary Outcome Measures

Name	Time	Method
Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS	Baseline, 2 weeks, 6 weeks	1) The PROMIS questionnaire contains 1 PROMIS global item: Pain NRS, Scale: 0-10 (anchors: 0 = No Pain, 10 = Worst Imaginable Pain, higher score is worse). The PROMIS global item is not scored but reported in raw score.
Kinetic Measure - Spinal Segment Load (SSL) Force	6 weeks	SSL\* contains variables: maximum amplitude (Newton) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Kinetic Measure - Spinal Segment Load (SSL) Moment	6 weeks	SSL\* contains variables: maximum amplitude (Newton\Meter for moment) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force	6 weeks	SSL\* contains variables: rate of loading for force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Bothersomeness	Baseline, 2 weeks, 6 weeks	Question asked of participants: "During the past week, how bothersome have each of the following symptoms been?" The bothersomeness questionnaire contains two items: a) low back pain \& b) leg pain (sciatica). Scale: 0-10 (anchors: 0 = Not at all bothersome, 10 = Extremely bothersome)
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment	6 weeks	SSL\* contains variables: rate of loading for moment in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale	Baseline, 2 weeks, 6 weeks	1) The questionnaire contains 7 PROMIS-29 specific items: Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction with Participation in Social Role (anchors: 1= 'Not at all', 5= 'Very much', higher score is worse). Each PROMIS-29 specific item is reported in raw score (4-20) and scored in T-score (T), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for a population. On the T-score metric \& interpretation: * A score of 40 is one SD lower than the mean of the reference population. * A score of 60 is one SD higher than the mean of the reference population. * For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.