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

NCT ID: NCT03736148

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-20
• Study Completion Date: 2015-12-03

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Manual Manipulation

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

Group Type: EXPERIMENTAL

Manual Manipulation

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Instrument-assisted Manipulation

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Control

No contact was given to the subject.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Manual Manipulation

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role: lead

Responsible Party

Nuno Filipe Pinho Nogueira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20122018

Identifier Type: -

Identifier Source: org_study_id