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Completed

NCT Number: NCT03463343

Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception. The muscles evaluated were upper trapezius and biceps brachialis, bilaterally. The study also had a placebo and a control group. All individuals were asymptomatic.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects.
  • Minimum of 18 years old.

Exclusion criteria

  • Pain in cervical region, shoulders or arms.
  • History of trauma or disease in the cervical region or upper limb.
  • Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.

Treatment and study plan

Cervical spine manual manipulation

Other

In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered.

Cervical spine mechanical manipulation

Other

In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.

Placebo intervention

Other

The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.

Primary outcomes

  1. Pressure pain thresholds

    Time frame: Immediately after the intervention

    To measure the pressure pain threshold, it was used an electronic pressure dynamometer FORCE ONE™ FDIX (Wagner Instruments - Greenwich, USA), with 1cm2 of surface. The values were expressed in Kg/cm2. The pressure was increased at a rate of 1 kg/cm2/s until the subject inform that the sense of pressure has become a sense of pain.

  2. Pressure pain perception

    Time frame: Immediately after the intervention

    To evaluate the pressure pain perception, it was used a Visual Analogue Scale (VAS). The pressure increased until 2,5 kg/cm2 and was hold for 5 seconds, and the subject used the VAS scale to record the pressure pain perception he felt.

Secondary outcomes

  1. Muscle tone

    Time frame: Immediately after the intervention

    To measure muscle tone it was used the MyotonPro device. It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The non-neural tone was recorded as frequency.

  2. Muscle stiffness

    Time frame: Immediately after the intervention

    To measure muscle stiffness it was used the MyotonPro device. It was used to evaluate this parameter both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The muscle stiffness was recorded as N/m.

  3. Muscle elasticity

    Time frame: Immediately after the intervention

    To measure muscle elasticity it was used the MyotonPro device. It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The elasticity was indicated by logarithmic decrement.

Sponsors and collaborators

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Mar 13, 2018
Registry last updated
Mar 14, 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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