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

NCT01766141 | Completed DMC

• 1 other identifier: 122002
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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

Conditions

Low Back Pain

Keywords

Spinal manipulation; Tumor necrosis factor; Interleukin 1; Interleukin 10; Inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• Determining proinflammatory cytokine (TNFα and IL-1β) levels in acute and chronic low back pain patients and in healthy asymptomatic subjects.

  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.

  Baseline (time zero) determinations to compare acute vs chronic vs control.

Secondary Outcomes (1)

• Determining if spinal manipulative treatment will cause significant changes in the level of proinflammatory cytokine production in vitro.

  Baseline and 2 weeks i.e on the 7th visit of patients.

Other Outcomes (1)

• Determining the levels of anti-inflammatory mediators (IL-10, IL-1ra) and chemokines produced in the same cultures.

  Baseline and 2 weeks i.e on the 7th visit of patients.

Study Arms (3)

Acute versus chronic low back pain

NO INTERVENTION

No manipulative intervention. Phlebotomy for inflammatory biomarker determinations to compare acute versus chronic at baseline.

Spinal manipulation (SMT)

EXPERIMENTAL

Inflammatory biomarker determinations after a course of 6 SMT interventions over the period of 2 weeks; a single SMT per treatment.

Other: Spinal manipulation

No treatment controls

NO INTERVENTION

Asymptomatic subjects. Biomarker determinations at time zero and again two weeks later.

Interventions

Spinal manipulation OTHER

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.

Spinal manipulation (SMT)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For Asymptomatic controls:
• Adults between the ages of 20 and 60 years
• No pain of any etiology
• No inflammatory conditions including musculoskeletal complaints
• No diabetes
• No neoplasms
• No spinal manipulative treatments for the past 4 weeks
• Willing to sign informed consent
• For low back patients:
• Adults between the ages of 20 and 60 years
• 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.
• No fractures
• NoInflammatory conditions
• No other pain complaints
• No diabetes

You may not qualify if:

• \<20 or \>60 years of age.
• Having experienced low back pain longer than 4 wks but less than 12 wks
• Experiencing less than 3/10 pain as judged by a VAS score determined at time of presentation to study.
• 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).
• Currently experiencing significant pain (sprain/strain) anywhere in the body other than the low back.
• Having been diagnosed with back pain of non-mechanical origin, including seronegative arthropathies, fibromyalgia, inflammatory joint conditions, infections, and tumors.
• 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).
• Having been diagnosed with/experienced any infections in past 4 weeks (including common cold, oral/genital herpes, etc).
• Having a blood clotting disorder.
• Having received anti-inflammatory, immunosuppressive, immunostimulatory (e.g. immunization) or anticoagulant medications during the past 2 weeks.
• Having received a spinal manipulative treatment during the past 4 weeks.
• Unwilling to sign study consent form.
• Unwilling/unable to adhere to study schedule. -

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead

Study Sites (1)

Outpatient clinics, Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

Related Publications (1)

• Teodorczyk-Injeyan JA, Triano JJ, Gringmuth R, DeGraauw C, Chow A, Injeyan HS. Effects of spinal manipulative therapy on inflammatory mediators in patients with non-specific low back pain: a non-randomized controlled clinical trial. Chiropr Man Therap. 2021 Jan 8;29(1):3. doi: 10.1186/s12998-020-00357-y.

  PMID: 33413508 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• H. S. Injeyan, PhD, DC

  Canadian Memorial Chiropractic College, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Pathology and Microbiology

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: April 1, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

CA (1)