Patient Response to Spinal Manipulation
| Status: | Completed |
|---|---|
| Conditions: | Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 12/7/2017 |
| Start Date: | September 2012 |
| End Date: | June 2014 |
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).
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).
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.
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.
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
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