Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

Not Applicable

Completed

• Conditions: 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

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