Patient Response to Spinal Manipulation
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
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).
Key facts
- Study ID
- NCT01670292
- Run by
- Palmer College of Chiropractic
- People needed
- 82
- Starts
- 2012-09-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2017-12-05
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Palmer College of Chiropractic — Davenport, Iowa, United States
Full record on ClinicalTrials.gov
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