MultifidusNCT00155948
Estimation of Muscle Area and Thickness of Deep Cervical Muscle Contraction During Cervical and Limb Movements
An observational study of Multifidus, run by National Taiwan University Hospital.
Trial summary
The purpose of this study is to investigate the validity and reliability of measurement for cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle function by the change pattern of multifidus thickness, and to compare the changes in muscle thickness among different resistance levels… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Multifidus
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to May 2004
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- participants without posterior cervical pain within recent 3 months before entry the study
Who cannot join
- Posterior cervical pain
- Surgery over cervical spine
About this study
The purpose of this study is to investigate the validity and reliability of measurement for cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle function by the change pattern of multifidus thickness, and to compare the changes in muscle thickness among different resistance levels (rest, 25%, 50%, 75% and 100%) and different cervical levels (C4, C5 and C6).
Read the detailed description
Cervical multifidus has specific sensory and motion function. However, it was unclear about muscle architectural change of cervical multifidus during head retraction manoeuvre with progressive resistance. The validity and reliability of measuring cervical multifidus using ultrasonography hasn't been proven.
In the pilot study, thickness, width and area of multifidus were measured at C4, C5 and C6 were measured using MRI and ultrasonography. The limit of agreement and the regression analysis were used to compare the results of two modalities. Besides, muscle thickness was repeatedly measured during the static and head retraction manoeuvre using ultrasonography by the same rater on the same day; the CVw and CVb were used to investigate reliability. In the main study, multifidus architecture measured in twenty asymptomatic subjects (24.3±4.7 yo, 5 women and 15 men) during head retraction manoeuvre with progressive resistance and during relaxation using ultrasonography apparatus with 10MHz linear transducer. ANOVA with repeated measurement and post-hoc analysis were to investigate the difference among different cervical levels and resistance force levels.
The results of the pilot study showed that the limit of agreement was ±0.20 cm and the moderate level of correlation (R2 ranged in 0.42~0.64) for muscle thickness measured between MRI and ultrasonography. For muscle thickness, the CVw values under static and under head retraction against maximum resistance were lower than 10%. In the main study, there was a curvilinear relationship between muscle thickness change and resistance, and the quadratic equations were the proper curves for estimation. There was significant difference of muscle thickness change within 50% of maximum retraction against resistance; and there was no significant difference among three cervical levels. It was suggested that muscle at C6 relaxed more slowly during the period from the beginning of relaxation.
In conclusion, the present study built a valid and reliable method for measuring continuous and dynamic changes of muscle thickness using ultrasonography. The results supported muscle function of cervical multifidus for segmental stability but not for force production.
- Conditions
- Multifidus
- Keywords
- Ultrasonography, Cervical Multifidus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultifidusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shwu-Fen Wang, Ph.D., Principal investigator, School and graduate institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155948
- Sponsor's protocol ID
- 9261701132
- Status last verified
- Apr 2004
- First submitted
- 9 Sep 2005
- Last updated
- 20 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Muscle Area and Thickness of Deep Cervical Muscle Contraction During Cervical and Limb Movements
- ClinicalTrials.gov ID
- NCT00155948
- Acronym / sponsor ID
- 9261701132
- Conditions
- Multifidus
- Keywords
- Ultrasonography, Cervical Multifidus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- May 2004
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to investigate the validity and reliability of measurement for cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle function by the change pattern of multifidus thickness, and to compare the changes in muscle thickness among different resistance levels (rest, 25%, 50%, 75% and 100%) and different cervical levels (C4, C5 and C6).
Detailed description
Cervical multifidus has specific sensory and motion function. However, it was unclear about muscle architectural change of cervical multifidus during head retraction manoeuvre with progressive resistance. The validity and reliability of measuring cervical multifidus using ultrasonography hasn't been proven.
In the pilot study, thickness, width and area of multifidus were measured at C4, C5 and C6 were measured using MRI and ultrasonography. The limit of agreement and the regression analysis were used to compare the results of two modalities. Besides, muscle thickness was repeatedly measured during the static and head retraction manoeuvre using ultrasonography by the same rater on the same day; the CVw and CVb were used to investigate reliability. In the main study, multifidus architecture measured in twenty asymptomatic subjects (24.3±4.7 yo, 5 women and 15 men) during head retraction manoeuvre with progressive resistance and during relaxation using ultrasonography apparatus with 10MHz linear transducer. ANOVA with repeated measurement and post-hoc analysis were to investigate the difference among different cervical levels and resistance force levels.
The results of the pilot study showed that the limit of agreement was ±0.20 cm and the moderate level of correlation (R2 ranged in 0.42~0.64) for muscle thickness measured between MRI and ultrasonography. For muscle thickness, the CVw values under static and under head retraction against maximum resistance were lower than 10%. In the main study, there was a curvilinear relationship between muscle thickness change and resistance, and the quadratic equations were the proper curves for estimation. There was significant difference of muscle thickness change within 50% of maximum retraction against resistance; and there was no significant difference among three cervical levels. It was suggested that muscle at C6 relaxed more slowly during the period from the beginning of relaxation.
In conclusion, the present study built a valid and reliable method for measuring continuous and dynamic changes of muscle thickness using ultrasonography. The results supported muscle function of cervical multifidus for segmental stability but not for force production.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- participants without posterior cervical pain within recent 3 months before entry the study
Key exclusion criteria (2 listed)
- Posterior cervical pain
- Surgery over cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Dec 2005.
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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.
Shwu-Fen Wang, Ph.D. principal investigator
School and graduate institute of Physical Therapy, National Taiwan University
Questions about this trial
What is this clinical trial studying?
An observational study of Multifidus, run by National Taiwan University Hospital.
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 1 inclusion and 2 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 20 Dec 2005. 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. 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.
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 20 Dec 2005.