Healthy SubjectsNCT03463343
Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals
A study testing Cervical spine manual manipulation and Cervical spine mechanical manipulation in people with Healthy Subjects, run by Escola Superior de Tecnologia da Saúde do Porto.
Trial summary
This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Cervical spine manual manipulation and Cervical spine mechanical manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 Oct 2016
- 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
- Healthy subjects.
- Minimum of 18 years old.
Who cannot join
- Pain in cervical region, shoulders or arms.
- History of trauma or disease in the cervical region or upper limb.
- Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.
About this study
This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.
Read the detailed description
In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception. The muscles evaluated were upper trapezius and biceps brachialis, bilaterally. The study also had a placebo and a control group. All individuals were asymptomatic.
- Conditions
- Healthy Subjects
- Being tested
- Cervical spine manual manipulation, Cervical spine mechanical manipulation, Placebo intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical spine manual manipulationOther
In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered.
Cervical spine mechanical manipulationOther
In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
Placebo interventionOther
The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.
| Study group | Role | What they receive |
|---|---|---|
| Manual manipulation | Experimental | In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered. Receives: Other: Cervical spine manual manipulation |
| Mechanical manipulation | Active comparator | In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3. Receives: Other: Cervical spine mechanical manipulation |
| Placebo | Placebo comparator | The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position. Receives: Other: Placebo intervention |
| Control | No intervention | The subjects stayed in supine position and no intervention occurred. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain thresholds
To measure the pressure pain threshold, it was used an electronic pressure dynamometer FORCE ONE™ FDIX (Wagner Instruments - Greenwich, USA), with 1cm2 of surface. The values were expressed in Kg/cm2. The pressure was increased at a rate of 1 kg/cm2/s until the subject inform that the sense of pressure has become a sense of pain.
Measured: Immediately after the intervention
Pressure pain perception
To evaluate the pressure pain perception, it was used a Visual Analogue Scale (VAS). The pressure increased until 2,5 kg/cm2 and was hold for 5 seconds, and the subject used the VAS scale to record the pressure pain perception he felt.
Measured: Immediately after the intervention
Secondary outcomes (3)
Muscle tone
To measure muscle tone it was used the MyotonPro device. It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The non-neural tone was recorded as frequency.
Measured: Immediately after the intervention
Muscle stiffness
To measure muscle stiffness it was used the MyotonPro device. It was used to evaluate this parameter both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The muscle stiffness was recorded as N/m.
Measured: Immediately after the intervention
Muscle elasticity
To measure muscle elasticity it was used the MyotonPro device. It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The elasticity was indicated by logarithmic decrement.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 May 2013
- Primary completion1 Jul 2014
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 59 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
- Investigators
- Nuno Nogueira, MSc, Principal investigator, Instituto Politécnico da Saúde do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463343
- Sponsor's protocol ID
- 20122017
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals
- ClinicalTrials.gov ID
- NCT03463343
- Acronym / sponsor ID
- 20122017
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 13 Mar 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 had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.
Detailed description
In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception. The muscles evaluated were upper trapezius and biceps brachialis, bilaterally. The study also had a placebo and a control group. All individuals were asymptomatic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual manipulation | Experimental | Other: Cervical spine manual manipulationIn the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered. |
| Mechanical manipulation | Active comparator | Other: Cervical spine mechanical manipulationIn the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3. |
| Placebo | Placebo comparator | Other: Placebo interventionThe subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position. |
| Control | No intervention | –The subjects stayed in supine position and no intervention occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects.
- Minimum of 18 years old.
Key exclusion criteria (3 listed)
- Pain in cervical region, shoulders or arms.
- History of trauma or disease in the cervical region or upper limb.
- Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.
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 |
|---|---|---|
| Cervical spine manual manipulationIn the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered. | Other | Manual manipulation |
| Cervical spine mechanical manipulationIn the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3. | Other | Mechanical manipulation |
| Placebo interventionThe subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position. | Other | Placebo |
Primary outcome
Pressure pain thresholds
Time frame: Immediately after the intervention
To measure the pressure pain threshold, it was used an electronic pressure dynamometer FORCE ONE™ FDIX (Wagner Instruments - Greenwich, USA), with 1cm2 of surface. The values were expressed in Kg/cm2. The pressure was increased at a rate of 1 kg/cm2/s until the subject inform that the sense of pressure has become a sense of pain.
Pressure pain perception
Time frame: Immediately after the intervention
To evaluate the pressure pain perception, it was used a Visual Analogue Scale (VAS). The pressure increased until 2,5 kg/cm2 and was hold for 5 seconds, and the subject used the VAS scale to record the pressure pain perception he felt.
3 secondary outcomes
Muscle tone
Time frame: Immediately after the intervention
Muscle stiffness
Time frame: Immediately after the intervention
Muscle elasticity
Time frame: Immediately after the 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 14 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Nuno Nogueira, MSc principal investigator
Instituto Politécnico da Saúde do Norte
Questions about this trial
What is this clinical trial studying?
A study testing Cervical spine manual manipulation and Cervical spine mechanical manipulation in people with Healthy Subjects, 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 3 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 14 Mar 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?
Pressure pain thresholds (time frame: Immediately after the intervention). The study lists 2 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 14 Mar 2018.