Neck PainNCT01161758
Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
A study testing Passive cervical mobilisation and Manual contact in people with Neck Pain, run by Curtin University.
Trial summary
Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin. The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Passive cervical mobilisation and Manual contact
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 2005
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of neck or back pain over the last six months
- Without any previous experience with spinal manual therapy techniques
Who cannot join
- History of musculoskeletal or rheumatologic conditions
- Any kind of spinal surgery
- Dizziness
- Previous trauma to the cervical spine
- Neurological signs or symptoms
About this study
Official title: A Crossover Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin. The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain.
Read the detailed description
Cervical mobilization has been shown to elicit effects on pain perception, autonomic function and motor function in subjects who experience musculoskeletal pain. The improvement in motor function may be a direct effect of the treatment or secondary to a hypoalgesic effect. This study aims to demonstrate whether it is possible to alter motor function following joint mobilization, in situations where motor performance is not impaired by pain.
- Conditions
- Neck Pain
- Being tested
- Passive cervical mobilisation, Manual contact
- Keywords
- physical therapy, pain threshold, electromyography, musculoskeletal manipulation, neck muscles
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive cervical mobilisationOther
Also called Physiotherapy
Passive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment. The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
Manual contactOther
Also called placebo light touch
Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
| Study group | Role | What they receive |
|---|---|---|
| Passive cervical mobilisation | Active comparator | Grade III cervical mobilization technique as described by Maitland. Applied to left C5/6 Segment. Receives: Other: Passive cervical mobilisation |
| Manual contact | Placebo comparator | Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. Receives: Other: Manual contact |
| Non-contact control | No intervention | Non-contact control, which involved the subject resting in the treatment position without any physical contact between the researcher and the subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography of sternocleidomastoid muscle.
Measurement of sternocleidomastoid muscle activation during deep neck flexion. The degree of neck flexion is determined by a pressure biofeedback unit place underneath the neck. EMG of the left and right sternocleidomastoids are recorded for 5seconds at each level of neck flexion
Measured: Pre intervention (baseline) and 1 minute post intervention
Secondary outcomes (1)
Pressure pain threshold
The algometer to measure pressure pain threshold was applied at a constant rate of 40 kPa/sec on the posterior aspect of the left and right articular pillar of C5/C6.
Measured: Pre intervention (baseline) and 1 minute post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startApr 2005
- Primary completionOct 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Investigators
- Benjamin Soon Tze Chin, MManipTher, Principal investigator, The University of QueenslandAnnina Schmid, MManipTher, Principal investigator, The University of QueenslandElias Fridriksson, MManipTher, Principal investigator, Curtin UniversityPhilip Cheong, MManipTher, Principal investigator, Curtin UniversityElisabeth Gresslos, MManipTher, Principal investigator, Curitn University of TechnologyAnthony Wright, PhD, Study chair, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161758
- Sponsor's protocol ID
- PT0004
- Status last verified
- Nov 2005
- First submitted
- 8 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
- ClinicalTrials.gov ID
- NCT01161758
- Acronym / sponsor ID
- PT0004
- Conditions
- Neck Pain
- Keywords
- physical therapy, pain threshold, electromyography, musculoskeletal manipulation, neck muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Jul 2010 (estimated)
- 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.
Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin. The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain.
Detailed description
Cervical mobilization has been shown to elicit effects on pain perception, autonomic function and motor function in subjects who experience musculoskeletal pain. The improvement in motor function may be a direct effect of the treatment or secondary to a hypoalgesic effect. This study aims to demonstrate whether it is possible to alter motor function following joint mobilization, in situations where motor performance is not impaired by pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive cervical mobilisation | Active comparator | Other: Passive cervical mobilisationGrade III cervical mobilization technique as described by Maitland. Applied to left C5/6 Segment. |
| Manual contact | Placebo comparator | Other: Manual contactManual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. |
| Non-contact control | No intervention | –Non-contact control, which involved the subject resting in the treatment position without any physical contact between the researcher and the subject. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No history of neck or back pain over the last six months
- Without any previous experience with spinal manual therapy techniques
Key exclusion criteria (5 listed)
- History of musculoskeletal or rheumatologic conditions
- Any kind of spinal surgery
- Dizziness
- Previous trauma to the cervical spine
- Neurological signs or symptoms
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 |
|---|---|---|
| Passive cervical mobilisationAlso: PhysiotherapyPassive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment. The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between. | Other | Passive cervical mobilisation |
| Manual contactAlso: placebo light touchManual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between. | Other | Manual contact |
Primary outcome
Electromyography of sternocleidomastoid muscle.
Time frame: Pre intervention (baseline) and 1 minute post intervention
Measurement of sternocleidomastoid muscle activation during deep neck flexion. The degree of neck flexion is determined by a pressure biofeedback unit place underneath the neck. EMG of the left and right sternocleidomastoids are recorded for 5seconds at each level of neck flexion
1 secondary outcome
Pressure pain threshold
Time frame: Pre intervention (baseline) and 1 minute post 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 Jul 2010.
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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.
Benjamin Soon Tze Chin, MManipTher principal investigator
The University of Queensland
Annina Schmid, MManipTher principal investigator
The University of Queensland
Elias Fridriksson, MManipTher principal investigator
Curtin University
Questions about this trial
What is this clinical trial studying?
A study testing Passive cervical mobilisation and Manual contact in people with Neck Pain, run by Curtin University.
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 5 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 Jul 2010. 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?
Electromyography of sternocleidomastoid muscle. (time frame: Pre intervention (baseline) and 1 minute post intervention). 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 Jul 2010; AzTrials last refreshed its copy on 30 Oct 2026.