Effects of Spinal Manipulative Treatment on Inflammatory Markers in Low Back Pain Patients
Recruitment status was Recruiting
It is expected that mechanical low back pain (LBP) is associated with inflammatory changes localized to the affected tissues. Could such changes be detected in cells involved in the inflammatory process in an in vitro model? The investigators wish to test such a model to compare inflammatory markers in acute and chronic LBP patients and also examine the effect of spinal manipulative treatment (SMT) on changing the level of selected key inflammatory markers. The investigators hypothesize that:
- Proinflammatory markers will be elevated while antinflammatory markers will be reduced in acute LBP patients relative to chronic back pain patients as well as in healthy study participants who have no LBP or any inflammatory conditions (controls).
- SMT will cause a reduction in the production of proinflammatory markers while anti-inflammatory markers will increase relative to baseline levels as well as relative to controls
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Changes in Inflammatory Cytokine Levels in Response to Spinal Manipulative Treatment of Low Back Patients: A Single-blind Pilot Clinical Trial.|
- Determining proinflammatory cytokine (TNFα and IL-1β) levels in acute and chronic low back pain patients and in healthy asymptomatic subjects. [ Time Frame: Baseline (time zero) determinations to compare acute vs chronic vs control. ] [ Designated as safety issue: No ]Supernatants from whole blood cultures are collected 24 or 48 hours postincubation, are dispensed in 0.5-1.0 ml aliquots and stored at 76C. Because subject recruitment occurs over a long period,it is not desirable to process samples sporadically. This approach allows using same-batch reagents/bioassay kits for all samples in an effort to decrease error and enhance internal consistency. Results will be expressed as the difference between the values obtained for acute, chronic and control at baseline.
- Determining if spinal manipulative treatment will cause significant changes in the level of proinflammatory cytokine production in vitro. [ Time Frame: Baseline and 2 weeks i.e on the 7th visit of patients. ] [ Designated as safety issue: No ]Postintervention samples (whole blood culture supernatants) will be aliquoted and stored at -76C. proinflammatory cytokine levels will be compared to their respective baselines as well as the asymptomatic controls. These samples will be processed along with those for the primary outcome measure. Results will be expressed as the difference between baseline and endpoint (i.e. end of two week treatment period).
- Determining the levels of anti-inflammatory mediators (IL-10, IL-1ra) and chemokines produced in the same cultures. [ Time Frame: Baseline and 2 weeks i.e on the 7th visit of patients. ] [ Designated as safety issue: No ]Parallel bioassays will be done on samples from the same culture supernatants in order to determine the levels of antiinflammatory mediators and chemokines. Changes in the levels of these mediators in response to manipulative treatment may be correlated to changes in proinflammatory mediator levels. Results will be calculated as the difference between baseline and endpoint (i.e. end of two week treatment period).
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
No Intervention: Acute versus chronic low back pain
No manipulative intervention. Phlebotomy for inflammatory biomarker determinations to compare acute versus chronic at baseline.
Experimental: Spinal manipulation (SMT)
Inflammatory biomarker determinations after a course of 6 SMT interventions over the period of 2 weeks; a single SMT per treatment.
Other: Spinal manipulation
Spinal manipulation will consist of a single high velocity low amplitude thrust to a hypomobile vertebral segment determined by the treating clinician to contribute to the problem.
No Intervention: No treatment controls
Asymptomatic subjects. Biomarker determinations at time zero and again two weeks later.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766141
|Contact: H. S Injeyan, PhD, DC||416 482 2340 ext email@example.com|
|Contact: Igor Steiman, M.Sc, DCfirstname.lastname@example.org|
|Outpatient clinics, Canadian Memorial Chiropractic College||Recruiting|
|Toronto, Ontario, Canada, M2H 3J1|
|Contact: H. S. Injeyan email@example.com|
|Principal Investigator: H. S. Injeyan, PhD, DC|
|Principal Investigator:||H. S. Injeyan, PhD, DC||Canadian Memorial Chiropractic College, Toronto, Ontario, Canada|