Patient Response to Spinal Manipulation - Pilot Study
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will conduct a pilot study for the purposes of testing equipment, finalizing data collection protocol, and training study personnel before conducting the full-scale trial.
Key facts
- Study ID
- NCT01562756
- Run by
- Palmer College of Chiropractic
- People needed
- 6
- Starts
- 2012-02-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2017-07-31
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 21-65
- Signed informed consent document
- Chronic (12+ weeks) low back pain (LBP)
- Average pain within past 24 hours ≥ 2/10 at phone screen, baseline visit 1, and baseline visit 2
You may not qualify if…
- Compliance concerns such as refusal to shave body hair
- No manipulable lesion in L3, L4, 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)
- Comorbid Conditions:
- Serious Contaminant Illness
- Inflammatory or Destructive Spinal Tissue change
- Ankylosing Spondylitis
- Fibromyalgia
- Rheumatoid Arthritis
- Neuromuscular Disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis)
- Spinal Surgery < 6 mo
- Suspicion of drug or alcohol abuse
- Uncontrolled hypertension
- Peripheral Arterial Disease
- Undetermined, infectious or visceral source of LBP
- Other comorbid conditions prohibiting treatment and/or testing
- Safety Concerns
- Bleeding Disorders
- Contraindications to HVLA-SM
- Quebec Task Force (QTF) criterion 4-11:
- QTF 4: Pain + radiation to upper/lower limb with 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
Where it is running
- Palmer College of Chiropractic — Davenport, Iowa, United States
Full record on ClinicalTrials.gov
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