Effects of Manual vs Instrument-assisted Manipulation on Electromyographic Activity and Sympathetic Nervous System
Acute Effects of Manual vs Instrument-assisted Single Cervical Manipulation on Electromyographic Activity and Sympathetic Nervous System
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2015
CompletedFirst Submitted
Initial submission to the registry
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 8, 2018
CompletedNovember 8, 2018
November 1, 2018
6 months
November 1, 2018
November 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (4)
Manual Manipulation
EXPERIMENTALA single manual manipulation was applied to C3/C4 level, on the right side.
Instrument-assisted Manipulation
ACTIVE COMPARATORA single instrument-assisted manipulation was applied to C3/C4 level, on the right side.
Placebo
PLACEBO COMPARATORA 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.
Control
NO INTERVENTIONNo contact was given to the subject.
Interventions
Subject was in supine position, and the therapist applied a manual manipulation with right side bending and left rotation of the neck.
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.
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.
Eligibility Criteria
You may qualify if:
- Asymptomatic individuals
- Age above 18 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 1, 2018
First Posted
November 8, 2018
Study Start
January 20, 2015
Primary Completion
July 21, 2015
Study Completion
December 3, 2015
Last Updated
November 8, 2018
Record last verified: 2018-11