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

E

Escola Superior de Tecnologia da Saúde do Porto

Status

Completed

Conditions

Healthy

Treatments

Other: Placebo
Other: Instrument-assisted Manipulation
Other: Manual Manipulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03736148
20122018

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 4 patient groups, including a placebo group

Manual Manipulation
Experimental group
Description:
A single manual manipulation was applied to C3/C4 level, on the right side.
Treatment:
Other: Manual Manipulation
Instrument-assisted Manipulation
Active Comparator group
Description:
A single instrument-assisted manipulation was applied to C3/C4 level, on the right side.
Treatment:
Other: Instrument-assisted Manipulation
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
Control
No Intervention group
Description:
No contact was given to the subject.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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