Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

• Sponsor: Institut Franco Europeen de Chiropratique (Other)
• Overall Status: Completed
• CT.gov ID: NCT03776708
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 24.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Manipulation	Other: Spinal manipulation; Other: Sham procedure	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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; Other Names: Spinal manipulative therapy Adjustment
Sham Comparator: 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.	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; Other Names: Placebo procedure

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Franco Européen de chiropraxie (iFEC)	Ivry-sur-Seine	Val De Marne	France	94200

Sponsors and Collaborators

• Institut Franco Europeen de Chiropratique

Investigators

• Study Director: Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor, Institut Franco Européen de Chiropraxie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Margaux Honoré, Principal investigator, Institut Franco Europeen de Chiropratique
• ClinicalTrials.gov Identifier: NCT03776708
• Other Study ID Numbers: InstitutFEC
• First Posted: Dec 17, 2018
• Last Update Posted: Dec 19, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Margaux Honoré, Principal investigator, Institut Franco Europeen de Chiropratique: pressure pain threshold; asymptomatic subjects; duration

Study Results

No Results Posted as of Dec 19, 2018