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Completed

NCT Number: NCT03776708

Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

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

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Key information

Conditions

Spinal Manipulation

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Franco Européen de chiropraxie (iFEC)

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

About this study

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:

  • What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
  • What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
  • What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
  • What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other names: Spinal manipulative therapy, Adjustment

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

Other names: Placebo procedure

Primary outcomes

  1. Change of the Pressure Pain threshold

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Franco Europeen de Chiropratique

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2018
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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