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

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ClinicalTrials.gov Identifier: NCT03736148
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nuno Filipe Pinho Nogueira, Escola Superior de Tecnologia da Saúde do Porto

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Manual Manipulation Other: Instrument-assisted Manipulation Other: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized control placebo trial
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.
Primary Purpose: Treatment
Official Title: Acute Effects of Manual vs Instrument-assisted Single Cervical Manipulation on Electromyographic Activity and Sympathetic Nervous System
Actual Study Start Date : January 20, 2015
Actual Primary Completion Date : July 21, 2015
Actual Study Completion Date : December 3, 2015

Arm Intervention/treatment
Experimental: Manual Manipulation
A single manual manipulation was applied to C3/C4 level, on the right side.
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.

Active Comparator: Instrument-assisted Manipulation
A single instrument-assisted manipulation was applied to C3/C4 level, on the right side.
Other: 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 Comparator: Placebo
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.
Other: 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.

No Intervention: Control
No contact was given to the subject.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Nuno Filipe Pinho Nogueira, Principal Investigator, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier: NCT03736148     History of Changes
Other Study ID Numbers: 20122018
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nuno Filipe Pinho Nogueira, Escola Superior de Tecnologia da Saúde do Porto:
manipulation
electromyography
sympathetic nervous system