HealthyNCT03736148
Effects of Manual vs Instrument-assisted Manipulation on Electromyographic Activity and Sympathetic Nervous System
A study testing Manual Manipulation and Instrument-assisted Manipulation in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Manual Manipulation and Instrument-assisted Manipulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2015to 3 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic individuals
- Age above 18 years.
Who cannot join
- 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.
About this study
Official title: Acute Effects of Manual vs Instrument-assisted Single Cervical Manipulation on Electromyographic Activity and Sympathetic Nervous System
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.
Read the 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
- Being tested
- Manual Manipulation, Instrument-assisted Manipulation, Placebo
- Keywords
- manipulation, electromyography, sympathetic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ManipulationOther
Subject was in supine position, and the therapist applied a manual manipulation with right side bending and left rotation of the neck.
Instrument-assisted ManipulationOther
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Manipulation | Experimental | A single manual manipulation was applied to C3/C4 level, on the right side. Receives: Other: Manual Manipulation |
| Instrument-assisted Manipulation | Active comparator | A single instrument-assisted manipulation was applied to C3/C4 level, on the right side. Receives: Other: Instrument-assisted Manipulation |
| 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. Receives: Other: Placebo |
| Control | No intervention | No contact was given to the subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start20 Jan 2015
- Primary completion21 Jul 2015
- Study completion3 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized control placebo trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuno Filipe Pinho Nogueira, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736148
- Sponsor's protocol ID
- 20122018
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Manual vs Instrument-assisted Single Cervical Manipulation on Electromyographic Activity and Sympathetic Nervous System
- ClinicalTrials.gov ID
- NCT03736148
- Acronym / sponsor ID
- 20122018
- Conditions
- Healthy
- Keywords
- manipulation, electromyography, sympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 21 Jul 2015 (actual)
- Study completion
- 3 Dec 2015 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Double blind randomized control placebo trial
| Arm | Type | Receives |
|---|---|---|
| Manual Manipulation | Experimental | Other: Manual ManipulationA single manual manipulation was applied to C3/C4 level, on the right side. |
| Instrument-assisted Manipulation | Active comparator | Other: Instrument-assisted ManipulationA single instrument-assisted manipulation was applied to C3/C4 level, on the right side. |
| Placebo | Placebo comparator | Other: PlaceboA 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 intervention | –No contact was given to the subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic individuals
- Age above 18 years.
Key exclusion criteria (8 listed)
- Presence of cervical pain
- History of surgery and/neck trauma
- Osteoporosis
- Current use of anticoagulant therapy
- Presence of dizziness and/or vertigo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual ManipulationSubject was in supine position, and the therapist applied a manual manipulation with right side bending and left rotation of the neck. | Other | Manual Manipulation |
| Instrument-assisted ManipulationThe 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. | Other | Instrument-assisted Manipulation |
| PlaceboSubject 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. | Other | Placebo |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Manipulation and Instrument-assisted Manipulation in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic Nervous System activity through change in skin conductance values (time frame: 10 minutes post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.