Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

NCT ID: NCT03776708

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2018-12-01

Brief Summary

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

Detailed Description

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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?

Conditions

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Spinal Manipulation

Keywords

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pressure pain threshold asymptomatic subjects duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Spinal manipulation

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Spinal manipulative therapy Adjustment Placebo procedure

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Franco Europeen de Chiropratique

OTHER

Sponsor Role lead

Responsible Party

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Margaux Honoré

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor

Role: STUDY_DIRECTOR

Institut Franco Européen de Chiropraxie

Locations

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Institut Franco Européen de chiropraxie (iFEC)

Ivry-sur-Seine, Val De Marne, France

Site Status

Countries

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France

Other Identifiers

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InstitutFEC

Identifier Type: -

Identifier Source: org_study_id