Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

NCT03776708 | Completed

• 1 other identifier: InstitutFEC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Manipulation

Keywords

pressure pain threshold; asymptomatic subjects; duration

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

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

Sham procedure

SHAM COMPARATOR

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

Interventions

Spinal manipulation OTHER

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

Also known as: Spinal manipulative therapy, Adjustment

Spinal manipulation

Sham procedure OTHER

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

Also known as: Placebo procedure

Sham procedure

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Franco Europeen de Chiropratique: lead

Study Sites (1)

Institut Franco Européen de chiropraxie (iFEC)

Ivry-sur-Seine, Val De Marne, 94200, France

Location

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor

  Institut Franco Européen de Chiropraxie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: December 17, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

FR (1)