Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    150
  • sponsor
    Real Centro Universitario Maria Cristina
Updated on 31 December 2021
Accepts healthy volunteers

Summary

This is a mechanistic randomized controlled trial on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. It is designed as a mechanistic trial, in which the main objective is to identify which variables related to central sensitization can help predict the response to spinal manipulation, and the evolution of which of these variables can help explain clinical changes in chronic low back pain patients receiving spinal manipulative therapy.

Description

The study is a mechanistic randomized controlled trials on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. 100 chronic low back pain patients will be randomly allocated to receive 12 sessions over 4 weeks of spinal manipulative therapy or placebo spinal manipulation. The main objective is to identify variables related to a central sensitization or nociplastic pain phenotype can help predict the response to spinal manipulation. Additionally, changes in these variables during the treatment period will be used to identify potential pain mechanisms involved in pain relief by spinal manipulation. An additional group of 50 healthy volunteers will be used to measure the same variables and their evolution during 4 weeks in a healthy control population. Response to treatment will be measured according to changes in pain intensity and disability.

Details
Condition Chronic Low-back Pain
Treatment Placebo, Spinal manipulation
Clinical Study IdentifierNCT05162924
SponsorReal Centro Universitario Maria Cristina
Last Modified on31 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

diagnosis of primary chronic low back pain (performed in the initial evaluation or
previously received by a healthcare professional), with or without leg pain
minimum of three months of duration

Exclusion Criteria

diagnosis of neuropathic pain in the lower extremity
evidence of specific pathology affecting the lumbar spine
diagnosis of psychiatric disorder or pain disorder affecting the hand/thumb or in the
vicinity of the lumbar area
intake corticosteroids, opioids or anticytokine medications
pregnancy
having been treated with spinal manipulation in the previous 12 months
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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