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Completed

NCT Number: NCT03736148

Effects of Manual vs Instrument-assisted Manipulation on Electromyographic Activity and Sympathetic Nervous System

This study evaluates the effects of manual and instrument-assisted cervical manipulation on electromyographic activity and sympathetic nervous system. Subjects were divided in four groups, one group was submitted to a manual cervical manipulation, other group was submitted to an instrument-assisted cervical manipulation, other group was submitted to a sham manipulation and another group served as control.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The manual manipulation was applied over C3/C4, as the participants were positioned in supine with the cervical spine in a neutral position. Slight ipsilateral side flexion and contralateral rotation were introduced until tension was perceived in the tissues at the contact point. A high-velocity, low-amplitude thrust manipulation was directed upward and medially in the direction of the subject's contralateral eye.

The instrument-assisted manipulation was applied using a handheld Activator IV Adjusting Instrument. Contacts were made firm enough to prevent slipping of the rubber tip but not so firm as to load the spring, in consistence with customary clinical use of the instrument. The spring was then loaded by means of the instrument's trigger mechanism, and the impulse was delivered in an anterosuperior direction, over the posterolateral aspect of the vertebra on the right lamina-pedicle junction of C3.

The sham manipulation to the right C3/C4 segment was administered using the same 'set-up' as for the manual manipulation; however, once the barrier was engaged, the head was re-positioned to neutral with no thrust applied. The control group individuals were positioned supine for the same twenty minutes as the other groups and they received no manual contact.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Asymptomatic individuals
  • Age above 18 years.

Exclusion criteria

  • Presence of cervical pain
  • History of surgery and/neck trauma
  • Osteoporosis
  • Current use of anticoagulant therapy
  • Presence of dizziness and/or vertigo
  • Pregnancy
  • Cancer
  • Any other contra-indication to spinal manipulation.

Treatment and study plan

Manual Manipulation

Other

Subject was in supine position, and the therapist applied a manual manipulation with right side bending and left rotation of the neck.

Instrument-assisted Manipulation

Other

The instrument-assisted manipulation was applied using a handheld Activator IV Adjusting Instrument. Contacts were made firm enough to prevent slipping of the rubber tip but not so firm as to load the spring, in consistence with customary clinical use of the instrument. The spring was then loaded by means of the instrument's trigger mechanism, and the impulse was delivered in an anterosuperior direction, over the posterolateral aspect of the vertebra on the right lamina-pedicle junction of C3.

Placebo

Other

Subject was in supine position, and the therapist placed ths subject's cervical with right side bending and left rotation but no manual manipulation was applied.

Primary outcomes

  1. Sympathetic Nervous System activity through change in skin conductance values

    Time frame: 10 minutes post intervention

    The effect on sympathetic nervous system was compared between manual manipulation, instrument-assisted manipulation, placebo and control. The endodermic activity amplifier Galvanic Skin Response (GSR100C) was used to collect the skin conductance values.

  2. Change of electromyographic activity of upper trapezius after spinal manipulation

    Time frame: 10 minutes post intervention

    The effect on basal electromyographic activity of upper trapezius was compared between manual manipulation, instrument-assisted manipulation, placebo and control. Muscle activity was evaluated before and 10 minutes after each intervention.

  3. Change of electromyographic activity of biceps brachii after spinal manipulation

    Time frame: 10 minutes post intervention

    The effect on basal electromyographic activity of biceps brachii was compared between manual manipulation, instrument-assisted manipulation, placebo and control. Muscle activity was evaluated before and 10 minutes after each intervention.

Sponsors and collaborators

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto

Other

Registry information

Official study title

Acute Effects of Manual vs Instrument-assisted Single Cervical Manipulation on Electromyographic Activity and Sympathetic Nervous System

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2018
Registry last updated
Nov 8, 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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