Effects of Spinal Manipulative Treatment on Inflammatory Markers in Low Back Pain Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Canadian Memorial Chiropractic College
Sponsor:
Information provided by (Responsible Party):
Stephen Injeyan, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT01766141
First received: January 8, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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:

  1. 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).
  2. 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

Condition Intervention
Low Back Pain
Other: Spinal manipulation

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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).


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For Asymptomatic controls:

    1. Adults between the ages of 20 and 60 years
    2. No pain of any etiology
    3. No inflammatory conditions including musculoskeletal complaints
    4. No diabetes
    5. No neoplasms
    6. No spinal manipulative treatments for the past 4 weeks
    7. Willing to sign informed consent
  • For low back patients:

    1. Adults between the ages of 20 and 60 years
    2. Having low back pain of no longer than 4 weeks (acute) or longer than 12 weeks (chronic), with or without radiation to the lower extremity.
    3. No fractures
    4. NoInflammatory conditions
    5. No other pain complaints
    6. No diabetes
    7. No spinal manipulative treatments for the past 4 weeks
    8. Willing to sign informed consent

Exclusion Criteria:

  1. <20 or >60 years of age.
  2. Having experienced low back pain longer than 4 wks but less than 12 wks
  3. Experiencing less than 3/10 pain as judged by a VAS score determined at time of presentation to study.
  4. Failure of clinician to locate a musculoskeletal indicator that will reproduce/localize the patient's pain (e.g., localized muscle tightness, soft tissue tenderness, reproduction of symptoms on digital joint challenge).
  5. Currently experiencing significant pain (sprain/strain) anywhere in the body other than the low back.
  6. Having been diagnosed with back pain of non-mechanical origin, including seronegative arthropathies, fibromyalgia, inflammatory joint conditions, infections, and tumors.
  7. Having been diagnosed with inflammatory conditions in the past (e.g autoimmune diseases, psoriasis), or currently experiencing any inflammatory condition(s) (e.g. allergies, tooth extraction or other dental work).
  8. Having been diagnosed with/experienced any infections in past 4 weeks (including common cold, oral/genital herpes, etc).
  9. Having a blood clotting disorder.
  10. Having received anti-inflammatory, immunosuppressive, immunostimulatory (e.g. immunization) or anticoagulant medications during the past 2 weeks.
  11. Having received a spinal manipulative treatment during the past 4 weeks.
  12. Unwilling to sign study consent form.
  13. Unwilling/unable to adhere to study schedule. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766141

Contacts
Contact: H. S Injeyan, PhD, DC 416 482 2340 ext 172 sinjeyan@cmcc.ca
Contact: Igor Steiman, M.Sc, DC 416-864-3004 steimani@smh.ca

Locations
Canada, Ontario
Outpatient clinics, Canadian Memorial Chiropractic College Recruiting
Toronto, Ontario, Canada, M2H 3J1
Contact: H. S. Injeyan       sinjeyan@cmcc.ca   
Principal Investigator: H. S. Injeyan, PhD, DC         
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Investigators
Principal Investigator: H. S. Injeyan, PhD, DC Canadian Memorial Chiropractic College, Toronto, Ontario, Canada
  More Information

No publications provided

Responsible Party: Stephen Injeyan, Professor and Chair Department of Pathology and Microbiology, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT01766141     History of Changes
Other Study ID Numbers: 122002
Study First Received: January 8, 2013
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Canadian Memorial Chiropractic College:
Spinal manipulation
Tumor necrosis factor
Interleukin 1
Interleukin 10
Inflammatory cytokines

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014