Compression of Spinal Nerve RootNCT01744899
Soleus H-Reflex in Different Sitting Postures
An observational study of Compression of Spinal Nerve Root and Spinal Disorder, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this study was to examine the effect of prolonged sitting duration and three different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve root function by measuring the soleus (SOL) H-reflex amplitude. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Compression of Spinal Nerve Root, Spinal Disorder, Low Back Pain
- What is being tested?
- Sitting posture
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2012
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults from both genders.
Who may be able to join
- Able to read, speak, and understand English
Who cannot join
- Current complaint of low back pain.
- Current injury to the ankle and/or foot.
- Limited ankle movement.
- Leg length discrepancy.
- Scoliosis.
- History of:
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- Back surgery.
- Calf muscle injury/surgery.
- Radicular symptoms.
- Peripheral neuropathy.
- Upper motor neuron lesion.
- Systemic and metabolic diseases.
- Cancer.
- Pregnant at the time of the study.
- Use of pain medications at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Different Sitting Postures on Soleus H-Reflex in Normal Subjects
The purpose of this study was to examine the effect of prolonged sitting duration and three different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure under the ischial tuberosities during the three sitting postures were assessed and correlated with the SOL H-reflex amplitude.
Read the detailed description
Participants were assigned to two groups (prolonged sitting group and controls) based on their daily sitting duration with 15 participants in each group. The outcome measures were recorded during erect, slumped and slouched sitting postures. The differences between the two groups and the three sitting postures in the outcome measures were examined for statistical significance.
- Being tested
- Sitting posture
- Keywords
- Lumbosacral spine, Nerve roots, Sitting, H-reflex
- Medical subject headings
- Radiculopathy, Spinal Diseases, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting postureOther
The outcomes were measured while the participants assumed erect, slumped and slouched sitting postures.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting | Includes individuals who spent an average of at least 6 hours a day sitting over the past year. Receives: Other: Sitting posture | |
| Control | Includes individuals who spent 4 hours or less/day sitting over the past year. Receives: Other: Sitting posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbosacral nerve root function by as measured by the soleus H-reflex amplitude
Measured: The outcome was measured during one session that lasted for an average of 3 hours. No further measurement was performed after that session.
Secondary outcomes (1)
Pressure under the ischial tuberosities
Pressure under the ischial tuberosities was measured in millimeter of mercury (mmHg), with 0 mmHg representing no ischial pressure and 644 mmHg representing the highest pressure.
Measured: The outcome was measured during one session that lasted for an average of 3 hours. No further measurement was performed after that session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compression of Spinal Nerve RootStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Saudi Arabian Cultural Mission to the United States
- Responsible party
- Principal investigator, Hamad Al Amer, Texas Woman's University
- Investigators
- Hamad S Al Amer, MS, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744899
- Sponsor's protocol ID
- 16518
- Status last verified
- Dec 2012
- First submitted
- 26 Sep 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Sitting Postures on Soleus H-Reflex in Normal Subjects
- ClinicalTrials.gov ID
- NCT01744899
- Acronym / sponsor ID
- 16518
- Keywords
- Lumbosacral spine, Nerve roots, Sitting, H-reflex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- The Saudi Arabian Cultural Mission to the United States
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Dec 2012 (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 was to examine the effect of prolonged sitting duration and three different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure under the ischial tuberosities during the three sitting postures were assessed and correlated with the SOL H-reflex amplitude.
Detailed description
Participants were assigned to two groups (prolonged sitting group and controls) based on their daily sitting duration with 15 participants in each group. The outcome measures were recorded during erect, slumped and slouched sitting postures. The differences between the two groups and the three sitting postures in the outcome measures were examined for statistical significance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting | – | Other: Sitting postureIncludes individuals who spent an average of at least 6 hours a day sitting over the past year. |
| Control | – | Other: Sitting postureIncludes individuals who spent 4 hours or less/day sitting over the past year. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults from both genders.
Key inclusion criteria (1 listed)
- Able to read, speak, and understand English
Key exclusion criteria (15 listed)
- Current complaint of low back pain.
- Current injury to the ankle and/or foot.
- Limited ankle movement.
- Leg length discrepancy.
- Scoliosis.
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 |
|---|---|---|
| Sitting postureThe outcomes were measured while the participants assumed erect, slumped and slouched sitting postures. | Other | Control, Prolonged sitting |
Primary outcome
Lumbosacral nerve root function by as measured by the soleus H-reflex amplitude
Time frame: The outcome was measured during one session that lasted for an average of 3 hours. No further measurement was performed after that session.
1 secondary outcome
Pressure under the ischial tuberosities
Time frame: The outcome was measured during one session that lasted for an average of 3 hours. No further measurement was performed after that session.
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 7 Dec 2012.
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.
Hamad S Al Amer, MS principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compression of Spinal Nerve Root and Spinal Disorder, run by Texas Woman's University at 1 site in United States.
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 15 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 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Lumbosacral nerve root function by as measured by the soleus H-reflex amplitude (time frame: The outcome was measured during one session that lasted for an average of 3 hours. No further measurement was performed after that session.). 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 7 Dec 2012.