N/A Completed N=6 Treatment

Patient Response to Spinal Manipulation - Pilot Study

Source: ClinicalTrials.gov NCT01562756 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcomePrimary: Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study — 19; 9; 6; 6 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study	19; 9; 6; 6	—
PRIMARY Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.	4	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 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
Sensitivity to adhesive
Additional diagnostic procedures other than x-ray necessary
BDI-II > 29
Retention of legal advice and open or pending case related to LBP
BMI > 40
Unwilling to have low back and wrist shaved
Seeking or receiving compensation for any disability?

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01562756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.