Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

Spinal Manipulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776708
• Other study ID #: InstitutFEC
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Institut Franco Europeen de Chiropratique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Spinal Manipulation

Intervention

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
• 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

Locations

Country	Name	City	State
France	Institut Franco Européen de chiropraxie (iFEC)	Ivry-sur-Seine	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Institut Franco Europeen de Chiropratique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.