Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain

January 23, 2023 updated by: Real Centro Universitario Maria Cristina

Efficacy of Chiropractic Spinal Manipulative Therapy in Patients With Primary Chronic Low Back Pain: a Mechanistic Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Madrid
      • San Lorenzo De El Escorial, Madrid, Spain, 28200
        • Real Centro Universitario María Cristina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Healthy volunteers will be accepted for that specific comparison group. Those volunteers must demonstrate no evidence of any systemic pathology, inflammatory, psychiatric, neurological or pain condition.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spinal manipulation
Group receiving 12 sessions of spinal manipulative therapy in the lumbar area
Other: Spinal Manipulation
Manual therapy technique applied by a chiropractor in the form of a high-velocity low-amplitude force to the lumbopelvic spine
Placebo Comparator: Placebo
Group receiving 12 sessions of placebo spinal manipulative therapy in the lumbar area
Other: Placebo
Placebo spinal manipulation consisting in the application by a chiropractor of a lower-velocity lower-amplitude force to gluteal muscles in a non-intentional direction
No Intervention: Healthy controls
A healthy control population will receive no treatment during the same time period (4 weeks) to measure the same physiological variables and their evolution.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 weeks
Pain intensity will be measured by showing patients a numerical rating scale from 0 (no pain at all) to 100 (maximum possible pain), and patients will rate with a number their current pain, highest, lowest and average during the 7 previous days (baseline) or the days following the previous session.
4 weeks
Oswestry Low Back Pain Disability Index
Time Frame: 4 weeks
The Oswestry Disability Index (ODI) questionnaire provides the level of self-reported disability in activities of daily living (ADL) related to low back pain. It includes 10 items rated on a Likert scale from 0-5. The total range of possible scores is from 0-50, where 0 means no disability at all, and 50 is the maximal disability.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale
Time Frame: 4 weeks
The Pain Catastrophizing Scale (PCS) provides the level of catastrophizing beliefs and emotions that a person has with regards to his/her own pain experience, in this case, low back pain. It includes 13 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-52, where 0 is the lowest possible level of catastrophizing and 52 the highest. This scale will also be used in healthy participants.
4 weeks
Central Sensitization Inventory
Time Frame: 4 weeks
The Central Sensitization Inventory (CSI) identifies key symptoms associated with central sensitization and provides a quantification for the degree of these symptoms, which help to identify a central sensitization phenotype patients with chronic pain. It includes 25 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-100, where 0 is the lowest possible level of central sensitization symptoms and 100 the highest. Additionally, the CSI asks one more question related to the previous diagnosis of either one of 10 conditions that have been related to central sensitization. this part is informative and is not used for scoring purposes. This scale will also be used in healthy participants.
4 weeks
Pressure pain thresholds
Time Frame: 4 weeks
Pressure pain thresholds (PPTs) are part of quantitative sensory testing. The aim is to identify the threshold and the sensitivity to suprathreshold pressure stimulation in different areas of the patients' bodies. A digital algometer will be used (Wagner Force Dial FPX, Greenwich, CT, USA) to measure PPTs in the lumbar segment of greatest pain for each patient (2cm lateral to the spinous process or the posterosuperior iliac spine if applicable) locally, in the dermatome of this segment in the lower limbs, at the regional level four segments cranial from the segment of greatest pain, and remotely at the level of the thenar eminences. Measures will always be taken bilaterally two times, and averaged. At that time, the patient will rate in a numerical rating scale from 0 to 100 the intensity of the first painful stimulation (suprathreshold sensitivity). For healthy participants, pressure pain thresholds will be measured at every segment of the lumbar spine and in the thenar eminences.
4 weeks
Urinary levels of cytokine Tumor Necrosis Factor alpha
Time Frame: 4 weeks
Tumor Necrosis Factor alpha (TNF-a) is a pro-inflammatory cytokines that have been involved with different stages of low back pain. First morning urine samples will be taken from patients and healthy participants at the beginning and the end of the trial period. Samples will be stored at -20ºC and concentrations will be measured with a sandwich ELISA. TNF-a will be the only cytokine used for before and after changes.
4 weeks
Beck Depression Inventory II
Time Frame: 4 weeks
The Beck Depression Inventory (BDI-II) identifies key symptoms associated with clinical depression and provides a quantification for the presence and severity of depressive symptoms. It includes 21 items rated on a Likert scale from 0-3. The total range of possible scores is from 0-63, where 0 is the lowest possible level of depressive symptoms and 63 the highest.This scale will also be used in healthy participants.
4 weeks
Generalized Anxiety Disorder scale
Time Frame: 4 weeks
The Generalized Anxiety Disorder (GAD) identifies key symptoms associated with generalized anxiety disorder and provides a quantification for the presence and severity of these symptoms. It includes 7 items rated on a Likert scale from 0-3. The total range of possible scores is from 0-63, where 0 is the lowest possible level of depressive symptoms and 21 the highest. The threshold of 10/21 is used to diagnose generalized anxiety disorder. This scale will also be used in healthy participants.
4 weeks
Expectations of pain relief
Time Frame: 4 weeks
Participants will rate in a numerical rating scale their expectations of pain relief at the end of the trial. It will consist on a scale from -100 (maximum reduction in current pain) to 0 (no change) to +100 (maximum imaginable pain increase).
4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain frequency
Time Frame: Baseline measurement for exploratory purposes
Chronic pain patients will describe whether their pain is episodic (pain-free periods of at least 4 week duration) or fluctuating (no pain-free periods of at least 4 week duration)
Baseline measurement for exploratory purposes
Pain duration
Time Frame: Baseline measurement for exploratory purposes
Pain duration at baseline since the onset of low back pain, described in months
Baseline measurement for exploratory purposes
Pain widespreadness
Time Frame: Baseline measurement for exploratory purposes
Patients will draw in a digital application (Symptom Mapper) the extent of their body affected by pain.
Baseline measurement for exploratory purposes
Pain in lower extremity
Time Frame: Baseline measurement and changes post-treatment for exploratory purposes
The presence of pain in the lower extremity concomitant or related to low back pain will be recorded as Yes/No answer.
Baseline measurement and changes post-treatment for exploratory purposes
Pain medication use
Time Frame: Baseline measurement and changes post-treatment for exploratory purposes
The use of pain medication (apart from the ones referred to in the exclusion criteria) will be reported as Yes/No answer, and a description will be noted.
Baseline measurement and changes post-treatment for exploratory purposes
Clinical criteria 1 for diagnosing central sensitization type of pain
Time Frame: Baseline measurement for exploratory purposes
A set of clinical criteria (defined by Smart et al., Manual Therapy 2015 and Nijs et al., Pain Physician 2015) will be used to classify patients as having central sensitization pain, this first one will be answered with a "Yes" or "No" regarding whether their pain is disproportionate to damage to lumbar tissues.
Baseline measurement for exploratory purposes
Clinical criteria 2 for diagnosing central sensitization type of pain
Time Frame: Baseline measurement for exploratory purposes
A set of clinical criteria will be used to classify patients as having central sensitization pain, this second one will be answered with a "Yes" or "No" regarding whether their pain has a diffuse anatomical distribution.
Baseline measurement for exploratory purposes
Sex
Time Frame: Baseline measurement for exploratory purposes
Biological sex (Male or Female)
Baseline measurement for exploratory purposes
Age
Time Frame: Baseline measurement for exploratory purposes
Age (measured in years)
Baseline measurement for exploratory purposes
Level of education
Time Frame: Baseline measurement for exploratory purposes
Education level (3 categories: basic, high school or university level)
Baseline measurement for exploratory purposes
Chronic disease comorbidities
Time Frame: Baseline measurement for exploratory purposes
The presence of other chronic disease comorbidities will be assessed as Yes/No answer.
Baseline measurement for exploratory purposes
Adverse reactions (type)
Time Frame: Will be collected at the beginning of every treatment session, except the first one
Type of adverse reaction to treatment (muscle stiffness, increased pain, radiating discomfort, and others - described by the patient)
Will be collected at the beginning of every treatment session, except the first one
Adverse reactions (onset)
Time Frame: Will be collected at the beginning of every treatment session, except the first one
Onset of adverse reaction to treatment (immediately, up to 24 hours, or more than 24 hours after the previous session)
Will be collected at the beginning of every treatment session, except the first one
Adverse reactions (duration)
Time Frame: Will be collected at the beginning of every treatment session, except the first one
Duration of adverse reaction to treatment (minutes, hours (< 24 hours), 24-48 hours, or > 48 hours)
Will be collected at the beginning of every treatment session, except the first one
Adverse reactions (severity)
Time Frame: Will be collected at the beginning of every treatment session, except the first one
Severity of adverse reaction to treatment (very mild, mild, moderate, severe, very severe)
Will be collected at the beginning of every treatment session, except the first one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Real Centro Universitario Maria Cristina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alcala
Université du Québec à Trois-Rivières
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arantxa Ortega-De Mues, PhD, Real Centro Universitario María Cristina
  • Principal Investigator: Mathieu Piché, PhD, Universite du Quebec à Trois-Rivieres

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMTCLBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication will be shared

IPD Sharing Time Frame

IPD data will be available in 2022 or immediately after publication

IPD Sharing Access Criteria

Data will be available upon request via email to the corresponding author of the publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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