Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

Not Applicable

Completed

• Conditions: Spinal Manipulation
• Interventions: Other: Sham procedure; Other: Spinal manipulation

• Registration Number: NCT03776708
• Lead Sponsor: Institut Franco Europeen de Chiropratique

Brief Summary

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

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-11
• Status Verified: 2018-12
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-17
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham procedure	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.
Spinal manipulation	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.

Primary Outcome Measures

Name	Time	Method
Change of the Pressure Pain threshold	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.

Trial Locations

Locations (1)

Institut Franco Européen de chiropraxie (iFEC); 🇫🇷 Ivry-sur-Seine, Val De Marne, France