Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

December 17, 2018 updated by: Margaux Honoré, Institut Franco Europeen de Chiropratique

What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study

Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.

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 effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. Further information is needed concerning its duration and its size.

Research questions:

  1. What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
  2. What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
  3. What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
  4. What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?

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.
50

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 Locations

  • France
    • Val De Marne
      • Ivry-sur-Seine, Val De Marne, France, 94200
        • Institut Franco Européen de chiropraxie (iFEC)

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subjects must be young (18-30 years old)
  • asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the BOX-scale).
  • Chiropractic students.

Exclusion Criteria:

  • The subjects must not be reporting any spinal pain lasting more than a month
  • and/or having taken painkillers 24h prior to the study.
  • Contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).

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: Crossover Assignment
  • Masking: None (Open Label)

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
The spinal manipulation is located between the fifth and eighth thoracic vertebrae, on a level and a side pain-free to a light palpation. The maneuver is of high velocity and low amplitude, oriented posterior to anterior, on the transverse process area of the chosen thoracic vertebrae.
Other: Spinal manipulation
Spinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain
Other Names:
  • Spinal manipulative therapy
  • Adjustment
Sham Comparator: Sham procedure
The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires.
Other: Sham procedure
The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires
Other Names:
  • Placebo procedure

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
Change of the Pressure Pain threshold
Time Frame: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.
Pressure Pain Threshold is defined as the minimal pressure that provokes a pain or a discomfort. It is considered as a valid and objective method, with a good reliability.
The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.

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.
Institut Franco Europeen de Chiropratique

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.
  • Study Director: Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor, Institut Franco Européen de Chiropraxie

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.
October 1, 2018

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 1, 2018

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.
December 1, 2018

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).
October 11, 2018

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 12, 2018

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, 2018

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.
December 19, 2018

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.
December 17, 2018

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.
December 1, 2018

More Information

Terms related to this study

Keywords

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.
  • InstitutFEC

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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