Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

Study Overview
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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: What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure? What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure? What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects? What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?

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

Conditions
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Spinal Manipulation

Intervention / Treatment
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* Other: Spinal manipulation
* Other: Sham procedure


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal manipulation<br>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<br>* 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<br>* Other names: Adjustment;|
| Sham Comparator: Sham procedure<br>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<br>* 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<br>* Other names: Placebo procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Pressure Pain threshold | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure pain threshold, asymptomatic subjects, duration