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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736148
• Other study ID #: 20122018
• Status: Completed
• Phase: N/A
• Start date: January 20, 2015
• Est. completion date: December 3, 2015

Study information

• Verified date: November 2018
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 3, 2015
• Est. primary completion date: July 21, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Manual Manipulation
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathetic Nervous System activity through change in skin conductance values	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.	10 minutes post intervention
Primary	Change of electromyographic activity of upper trapezius after spinal manipulation	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.	10 minutes post intervention
Primary	Change of electromyographic activity of biceps brachii after spinal manipulation	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.	10 minutes post intervention