N/A
N=82
Patient Response to Spinal Manipulation
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01670292 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ) — 20.1; 4.8 units on a scale (see description above)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HVLA-SM (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Palmer College of Chiropractic
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ) |
20.1; 4.8 | — |
| PRIMARY Lumbar-spine Stiffness (LSS) |
4.8; 4.3; 4.2; 7.7; 7.5; 7.6 | — |
| PRIMARY Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation |
0.5; 0.5; 0.5; 0.3; 0.3; 0.3 | — |
| PRIMARY Flexion-Relaxation Ratio (FRR) |
4.7; 5.8; 5.5; 9.2; 10.4; 9.4 | — |
| SECONDARY Kinetic Measure - Spinal Segment Load (SSL) Force |
-56.5; -67.0; -117.2; 170.3; -128.3; -172.3 | — |
| SECONDARY Kinetic Measure - Spinal Segment Load (SSL) Moment |
19.8; -1.0; -45.4; 58.5; 31.0; -3.4 | — |
| SECONDARY Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force |
-599.2; -598.1; -1145.2; 1537.5 | — |
| SECONDARY Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment |
51.3; -40.4; -210.2; 275.2 | — |
| SECONDARY PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale |
49.18; 47.93; 46.58; 47.02; 45.97; 44.38 | — |
| SECONDARY PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS |
5.57; 4.46; 3.59 | — |
| SECONDARY Bothersomeness |
6.18; 4.80; 3.63; 3.29; 2.61; 1.94 | — |
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).
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01670292). 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.