NCT01744899

Brief 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. In addition, the pressure under the ischial tuberosities during the three sitting postures were assessed and correlated with the SOL H-reflex amplitude.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

September 26, 2012

Last Update Submit

December 5, 2012

Conditions

Keywords

Lumbosacral spineNerve rootsSittingH-reflex

Outcome Measures

Primary Outcomes (1)

  • Lumbosacral nerve root function by as measured by the soleus H-reflex amplitude

    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

    The outcome was measured during one session that lasted for an average of 3 hours. No further measurement was performed after that session.

Study Arms (2)

Prolonged sitting

Includes individuals who spent an average of at least 6 hours a day sitting over the past year.

Other: Sitting posture

Control

Includes individuals who spent 4 hours or less/day sitting over the past year.

Other: Sitting posture

Interventions

The outcomes were measured while the participants assumed erect, slumped and slouched sitting postures.

ControlProlonged sitting

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults from both genders.

You may qualify if:

  • Able to read, speak, and understand English

You may not qualify if:

  • Current complaint of low back pain.
  • Current injury to the ankle and/or foot.
  • Limited ankle movement.
  • Leg length discrepancy.
  • Scoliosis.
  • History of:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

RadiculopathySpinal DiseasesLow Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hamad S Al Amer, MS

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

September 26, 2012

First Posted

December 7, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations