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Clinical Trials/NCT03736148
NCT03736148CompletedNot Applicable

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

Escola Superior de Tecnologia da Saúde do Porto0 sites75 target enrollmentStarted: January 20, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Primary Endpoint
Change of electromyographic activity of biceps brachii after spinal manipulation

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Electromyographic signal and skin conductance were assessed by blinded assessors before and immediately after the intervention. The participants were not aware of their assigned group.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • Any other contra-indication to spinal manipulation.

Arms & Interventions

Manual Manipulation

Experimental

A single manual manipulation was applied to C3/C4 level, on the right side.

Intervention: Manual Manipulation (Other)

Instrument-assisted Manipulation

Active Comparator

A single instrument-assisted manipulation was applied to C3/C4 level, on the right side.

Intervention: Instrument-assisted Manipulation (Other)

Placebo

Placebo Comparator

A placebo manipulation was applied on C3/C4 level, on the right side. The neck of th subject was placed in the pre manipulative position but no thrust was made. Then, the cervical was replaced in neutral position.

Intervention: Placebo (Other)

Control

No Intervention

No contact was given to the subject.

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nuno Filipe Pinho Nogueira

Principal Investigator

Escola Superior de Tecnologia da Saúde do Porto

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