Somatic Dysfunctions of PelvisNCT01097109
The Effect of Somatic Dysfunction of the Pelvis, Sacrum and Lower Lumbar Spine on Weight Bearing
An observational study of Somatic Dysfunctions of Pelvis and Somatic Dysfunctions of Sacrum, run by Nova Southeastern University at 1 site in United States.
Trial summary
The study aims to determine if somatic dysfunctions of the pelvis, sacrum and lower lumbar spine have an effect on weight bearing. Our subjects are young, healthy subjects without recent soft tissue or osseous injury, a less than predetermined leg length discrepancy or OMM/chiropractic treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Somatic Dysfunctions of Pelvis, Somatic Dysfunctions of Sacrum, Somatic Dysfunctions of Lower Lumbar Spine
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2010
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Medical students of Nova Southeastern University College of Osteopathic Medicine (NSUCOM) ages 18-40.
Who may be able to join
- Medical students of Nova Southeastern University College of Osteopathic Medicine (NSUCOM) ages 18-40.
Who cannot join
- individuals who have suffered from any type of osseous or soft tissue traumatic injuries in the last three months.
- individuals who have suffered from any type of osseous or soft tissue injuries in the lower extremity joints (knee, ankle, hip) in the last twelve months.
- anyone who has received either osteopathic or chiropractic manipulation within two weeks prior to taking part in the study.
- anyone who has a leg length difference of greater than one-quarter inch.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University College of Osteopathic Medicine
Fort Lauderdale, Florida, 33328
About this study
The study aims to determine if somatic dysfunctions of the pelvis, sacrum and lower lumbar spine have an effect on weight bearing. Our subjects are young, healthy subjects without recent soft tissue or osseous injury, a less than predetermined leg length discrepancy or OMM/chiropractic treatment. Their leg lengths will be measured; weight-bearing will be measured using a specialized scale and somatic dysfunctions diagnosed to determine if any correlation exists.
Read the detailed description
Most sources claim that in individuals with leg length discrepancies, they tend to place more weight through the shorter lower extremity.1,2 Few cases state that the opposite is true.3 Many health care practitioners diagnose leg length discrepancies. Osteopathic physicians who practice with Osteopathic Manipulative Medicine (OMM) will also diagnose leg length discrepancies. They use testing to evaluate whether a leg length discrepancy is structural or functional. A structural leg length discrepancy is associated with shortening of bony structures.4 The structures affected can be due to congenital defects, which result in possible structural shortening of the tibia or femur, slipped capital femoral epiphyses (SCFE), or congenital dislocation. Other causes of structural leg length discrepancies include post total hip replacement, infections, tumors, paralysis, and trauma, including fractures where the gross length of a limb is altered.4 A structural leg length discrepancy can be most accurately assessed by physically measuring the distance between the anterior superior iliac spine (ASIS) and medial malleolus.4 The most reliable method of diagnosing a structural short leg is through full body radiographs. 6 A functional leg length discrepancy is a result of altered mechanics of the lower extremities. It is thought that a functional short leg occurs secondarily to a rotated pelvis caused by joint contractures and/or axial misalignments, including scoliosis.4 In osteopathic literature; functional leg length discrepancies are also thought to be the result of altered positions of the pelvis and sacrum. It is also thought in osteopathic philosophy that the position of the fifth lumbar vertebra affects the position of the sacrum. Therefore dysfunction of L5 will change the position of the sacrum such that a functional short leg is created.2(p.780-782) A common cause of functional leg length discrepancies diagnosed by osteopathic physicians is that of sacral base unleveling.5 The way in which a leg length discrepancy causes unleveling of the sacrum is through the femoral head of the longer leg driving the pelvis into a posterior rotation via forces placed through acetabular contact. Then the pelvis will typically rotate forward in attempts to lengthen the shorter leg, causing the sacral base to become unlevel.5 In addition, the sacral base tilts toward the side of the short leg.6 Standing postural x-rays, which outline sacral declination, are often used by chiropractors and osteopathic physicians to diagnose functional leg length discrepancies.6 Another way that functional leg length discrepancies are confirmed is through the supine to long sitting test, which tests for the presence of innominate rotations that may affect leg length as the cause.
There is no research known to support the presence of somatic dysfunctions, leg length discrepancies and altered weight bearing through lower extremities secondary to this.
It is common practice among osteopathic physicians who utilize OMM to diagnose musculoskeletal somatic dysfunctions of the pelvis, sacrum and lumbar spine. All these findings can contribute to low back pain. Therefore, it is the common practice of these physicians to diagnose leg length discrepancies, as it may ultimately result in low back pain.
Somatic dysfunction in osteopathic nomenclature is defined as 'impaired or altered function of related components of the somatic (body framework) system: Skeletal, arthrodial and Myofascial structures, and related vascular, lymphatic and neural elements'.2
There are specific somatic dysfunctions that lead to leg length differences. These effects include the sacral base tilting toward the side of the short leg, a low iliac crest on the short leg side, a forward rotation of the innominate on the shorter side and/or a posterior rotation of the innominate on the side of the longer leg as a compensatory measure. The lumbar spine will develop a convexity toward the side of the short leg.6 Their definitions are as follows:
Anteriorly rotated innominate: Entire innominate appears to be rotated anterior in relation to the opposite innominate. The ASIS will be more inferior or caudad and PSIS will be more superior or cephalad.2(776-778), 6 Posteriorly rotated innominate: Entire innominate appears to be rotated posterior in relation to the opposite hip bone. The ASIS will be more superior or cephalad and the PSIS more inferior or caudad.2(776-778), 6 Superior shear of the innominate: ASIS, PSIS and pubic ramus is more superior or cephalad than the opposite side.2(776-778), 6 Inferior shear of the innominate: ASIS, PSIS and pubic ramus is more inferior or caudad than the opposite side.2(776-778), 6
The way that osteopathic physicians determine the side of the somatic dysfunction is through the ASIS compression test. This is defined as follows:
ASIS compression test: Test for lateralization of somatic dysfunction of the sacrum, innominate or pubic symphysis. A posterior compression normally produces a palpatory sense of 'give' or 'resilience' as the innominate glides slightly posterior at the sacroiliac joint on that side. Somatic dysfunction of the pelvis on the side of compression produces resistance to the test determining the side of lateralization which is analogous to the determining the dysfunctional side. This is interpreted as a positive ASIS compression test.2(777) Individuals who have suffered from any type of osseous or soft tissue traumatic injuries in the last three months do not make suitable subjects for an evaluation of somatic dysfunctions' effects on weight bearing. Neither do individuals who have suffered from any type of osseous or soft tissue injuries in the lower extremity joints (knee, ankle, hip) in the last twelve months. As stated earlier, leg length discrepancies may be a result of trauma. Individuals who have suffered traumatic injuries within the last three months may exhibit antalgic or compensatory postures which may displace weight bearing more through one lower extremity than the other.7 This will ensure that the treatment population will be as homogenous as possible and will improve reliability of the study.
Individuals who have suffered lower extremity injuries in the last twelve months may also exhibit altered weight bearing distribution through the lower extremities. This may be something, depending on the chronicity of the problem, which alters weight bearing for an extended period of time which may vary depending on the person.7 Therefore, excluding individuals who have suffered lower extremity trauma in the last twelve months will also be excluded from the study to allow for more homogenous characteristics of our sample population. The time constraints of three and twelve months respectively were deemed as the exclusion times purely from anecdotal and clinical experience with lower extremity injury from the principal investigator and his colleagues.
- White, S.C., Gilchrist, L.A., Wilk, B.E. Asymmetric limb loading with true or simulated leg-length differences. Clinical Orthopedics and Related Research, 2004,421,287-292
- Ward, R. Foundations for Osteopathic Medicine 2nd Edition. 2003, p. 614-618, 780
- McCaw, S.T., Bates, B.T. Biomechanical implications of mild leg length inequality. British Journal of Sports Medicine, 1991, 25,10-13
- Gurney, B. Review: Leg length discrepancy. Gait and Posture. 2002, 15,195-206
- Dott, G.A., Hart, C.L., McKay, C. Predictability of sacral base levelness based on iliac crest measurements. JAOA, 1994,4, 383-390.
- DiGiovanna, EL. Schiowitz S. An Osteopathic Approach to Diagnosis and Treatment. Philadelphia: Lippincott-Raven, 301.
- Riegger-Krugh, C \& Keysor, J.J. Skeletal malalignments of the lower quarter: Correlated and compensatory motions and postures. J. Orthop Sports Phys Ther. 1996;23(2):164-170.
- Conditions
- Somatic Dysfunctions of Pelvis, Somatic Dysfunctions of Sacrum, Somatic Dysfunctions of Lower Lumbar Spine, Weight-Bearing
- Keywords
- Effect of Somatic Dysfunctions of Pelvis, Effect of Somatic Dysfunctions of Sacrum, Effect of Somatic Dysfunctions of Lower Lumbar Spine, Weight-Bearing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Somatic Dysfunctions of PelvisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew kusienski, Nova Southeastern University
- Investigators
- Andrew M Kusienski, D.O., Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097109
- Sponsor's protocol ID
- 02171013Exp.
- Status last verified
- Apr 2012
- First submitted
- 30 Mar 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
White SC, Gilchrist LA, Wilk BE. Asymmetric limb loading with true or simulated leg-length differences. Clin Orthop Relat Res. 2004 Apr;(421):287-92. doi: 10.1097/01.blo.0000119460.33630.6d.
PubMed 15123962McCaw ST, Bates BT. Biomechanical implications of mild leg length inequality. Br J Sports Med. 1991 Mar;25(1):10-3. doi: 10.1136/bjsm.25.1.10.
PubMed 1913023Gurney B. Leg length discrepancy. Gait Posture. 2002 Apr;15(2):195-206. doi: 10.1016/s0966-6362(01)00148-5.
PubMed 11869914Dott GA, Hart CL, McKay C. Predictability of sacral base levelness based on iliac crest measurements. J Am Osteopath Assoc. 1994 May;94(5):383-90.
PubMed 8056627Riegger-Krugh C, Keysor JJ. Skeletal malalignments of the lower quarter: correlated and compensatory motions and postures. J Orthop Sports Phys Ther. 1996 Feb;23(2):164-70. doi: 10.2519/jospt.1996.23.2.164.
PubMed 8808518Ward, R. Foundations for Osteopathic Medicine 2nd Edition. 2003, p. 614-618, 780
DiGiovanna, EL. Schiowitz S. An Osteopathic Approach to Diagnosis and Treatment. Philadelphia: Lippincott-Raven, 301.
Qureshi Y, Kusienski A, Bemski JL, Luksch JR, Knowles LG. Effects of somatic dysfunction on leg length and weight bearing. J Am Osteopath Assoc. 2014 Aug;114(8):620-30. doi: 10.7556/jaoa.2014.127.
PubMed 25082970
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Somatic Dysfunction of the Pelvis, Sacrum and Lower Lumbar Spine on Weight Bearing
- ClinicalTrials.gov ID
- NCT01097109
- Acronym / sponsor ID
- 02171013Exp.
- Conditions
- Somatic Dysfunctions of Pelvis, Somatic Dysfunctions of Sacrum, Somatic Dysfunctions of Lower Lumbar Spine, Weight-Bearing
- Keywords
- Effect of Somatic Dysfunctions of Pelvis, Effect of Somatic Dysfunctions of Sacrum, Effect of Somatic Dysfunctions of Lower Lumbar Spine, Weight-Bearing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Apr 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.
The study aims to determine if somatic dysfunctions of the pelvis, sacrum and lower lumbar spine have an effect on weight bearing. Our subjects are young, healthy subjects without recent soft tissue or osseous injury, a less than predetermined leg length discrepancy or OMM/chiropractic treatment. Their leg lengths will be measured; weight-bearing will be measured using a specialized scale and somatic dysfunctions diagnosed to determine if any correlation exists.
Detailed description
Most sources claim that in individuals with leg length discrepancies, they tend to place more weight through the shorter lower extremity.1,2 Few cases state that the opposite is true.3 Many health care practitioners diagnose leg length discrepancies. Osteopathic physicians who practice with Osteopathic Manipulative Medicine (OMM) will also diagnose leg length discrepancies. They use testing to evaluate whether a leg length discrepancy is structural or functional. A structural leg length discrepancy is associated with shortening of bony structures.4 The structures affected can be due to congenital defects, which result in possible structural shortening of the tibia or femur, slipped capital femoral epiphyses (SCFE), or congenital dislocation. Other causes of structural leg length discrepancies include post total hip replacement, infections, tumors, paralysis, and trauma, including fractures where the gross length of a limb is altered.4 A structural leg length discrepancy can be most accurately assessed by physically measuring the distance between the anterior superior iliac spine (ASIS) and medial malleolus.4 The most reliable method of diagnosing a structural short leg is through full body radiographs. 6 A functional leg length discrepancy is a result of altered mechanics of the lower extremities. It is thought that a functional short leg occurs secondarily to a rotated pelvis caused by joint contractures and/or axial misalignments, including scoliosis.4 In osteopathic literature; functional leg length discrepancies are also thought to be the result of altered positions of the pelvis and sacrum. It is also thought in osteopathic philosophy that the position of the fifth lumbar vertebra affects the position of the sacrum. Therefore dysfunction of L5 will change the position of the sacrum such that a functional short leg is created.2(p.780-782) A common cause of functional leg length discrepancies diagnosed by osteopathic physicians is that of sacral base unleveling.5 The way in which a leg length discrepancy causes unleveling of the sacrum is through the femoral head of the longer leg driving the pelvis into a posterior rotation via forces placed through acetabular contact. Then the pelvis will typically rotate forward in attempts to lengthen the shorter leg, causing the sacral base to become unlevel.5 In addition, the sacral base tilts toward the side of the short leg.6 Standing postural x-rays, which outline sacral declination, are often used by chiropractors and osteopathic physicians to diagnose functional leg length discrepancies.6 Another way that functional leg length discrepancies are confirmed is through the supine to long sitting test, which tests for the presence of innominate rotations that may affect leg length as the cause.
There is no research known to support the presence of somatic dysfunctions, leg length discrepancies and altered weight bearing through lower extremities secondary to this.
It is common practice among osteopathic physicians who utilize OMM to diagnose musculoskeletal somatic dysfunctions of the pelvis, sacrum and lumbar spine. All these findings can contribute to low back pain. Therefore, it is the common practice of these physicians to diagnose leg length discrepancies, as it may ultimately result in low back pain.
Somatic dysfunction in osteopathic nomenclature is defined as 'impaired or altered function of related components of the somatic (body framework) system: Skeletal, arthrodial and Myofascial structures, and related vascular, lymphatic and neural elements'.2
There are specific somatic dysfunctions that lead to leg length differences. These effects include the sacral base tilting toward the side of the short leg, a low iliac crest on the short leg side, a forward rotation of the innominate on the shorter side and/or a posterior rotation of the innominate on the side of the longer leg as a compensatory measure. The lumbar spine will develop a convexity toward the side of the short leg.6 Their definitions are as follows:
Anteriorly rotated innominate: Entire innominate appears to be rotated anterior in relation to the opposite innominate. The ASIS will be more inferior or caudad and PSIS will be more superior or cephalad.2(776-778), 6 Posteriorly rotated innominate: Entire innominate appears to be rotated posterior in relation to the opposite hip bone. The ASIS will be more superior or cephalad and the PSIS more inferior or caudad.2(776-778), 6 Superior shear of the innominate: ASIS, PSIS and pubic ramus is more superior or cephalad than the opposite side.2(776-778), 6 Inferior shear of the innominate: ASIS, PSIS and pubic ramus is more inferior or caudad than the opposite side.2(776-778), 6
The way that osteopathic physicians determine the side of the somatic dysfunction is through the ASIS compression test. This is defined as follows:
ASIS compression test: Test for lateralization of somatic dysfunction of the sacrum, innominate or pubic symphysis. A posterior compression normally produces a palpatory sense of 'give' or 'resilience' as the innominate glides slightly posterior at the sacroiliac joint on that side. Somatic dysfunction of the pelvis on the side of compression produces resistance to the test determining the side of lateralization which is analogous to the determining the dysfunctional side. This is interpreted as a positive ASIS compression test.2(777) Individuals who have suffered from any type of osseous or soft tissue traumatic injuries in the last three months do not make suitable subjects for an evaluation of somatic dysfunctions' effects on weight bearing. Neither do individuals who have suffered from any type of osseous or soft tissue injuries in the lower extremity joints (knee, ankle, hip) in the last twelve months. As stated earlier, leg length discrepancies may be a result of trauma. Individuals who have suffered traumatic injuries within the last three months may exhibit antalgic or compensatory postures which may displace weight bearing more through one lower extremity than the other.7 This will ensure that the treatment population will be as homogenous as possible and will improve reliability of the study.
Individuals who have suffered lower extremity injuries in the last twelve months may also exhibit altered weight bearing distribution through the lower extremities. This may be something, depending on the chronicity of the problem, which alters weight bearing for an extended period of time which may vary depending on the person.7 Therefore, excluding individuals who have suffered lower extremity trauma in the last twelve months will also be excluded from the study to allow for more homogenous characteristics of our sample population. The time constraints of three and twelve months respectively were deemed as the exclusion times purely from anecdotal and clinical experience with lower extremity injury from the principal investigator and his colleagues.
- White, S.C., Gilchrist, L.A., Wilk, B.E. Asymmetric limb loading with true or simulated leg-length differences. Clinical Orthopedics and Related Research, 2004,421,287-292
- Ward, R. Foundations for Osteopathic Medicine 2nd Edition. 2003, p. 614-618, 780
- McCaw, S.T., Bates, B.T. Biomechanical implications of mild leg length inequality. British Journal of Sports Medicine, 1991, 25,10-13
- Gurney, B. Review: Leg length discrepancy. Gait and Posture. 2002, 15,195-206
- Dott, G.A., Hart, C.L., McKay, C. Predictability of sacral base levelness based on iliac crest measurements. JAOA, 1994,4, 383-390.
- DiGiovanna, EL. Schiowitz S. An Osteopathic Approach to Diagnosis and Treatment. Philadelphia: Lippincott-Raven, 301.
- Riegger-Krugh, C \& Keysor, J.J. Skeletal malalignments of the lower quarter: Correlated and compensatory motions and postures. J. Orthop Sports Phys Ther. 1996;23(2):164-170.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Medical students of Nova Southeastern University College of Osteopathic Medicine (NSUCOM) ages 18-40.
Key inclusion criteria (1 listed)
- Medical students of Nova Southeastern University College of Osteopathic Medicine (NSUCOM) ages 18-40.
Key exclusion criteria (4 listed)
- individuals who have suffered from any type of osseous or soft tissue traumatic injuries in the last three months.
- individuals who have suffered from any type of osseous or soft tissue injuries in the lower extremity joints (knee, ankle, hip) in the last twelve months.
- anyone who has received either osteopathic or chiropractic manipulation within two weeks prior to taking part in the study.
- anyone who has a leg length difference of greater than one-quarter inch.
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 24 Apr 2012.
- Background: PubMed 15123962White SC, Gilchrist LA, Wilk BE. Asymmetric limb loading with true or simulated leg-length differences. Clin Orthop Relat Res. 2004 Apr;(421):287-92. doi: 10.1097/01.blo.0000119460.33630.6d.
- Background: PubMed 1913023McCaw ST, Bates BT. Biomechanical implications of mild leg length inequality. Br J Sports Med. 1991 Mar;25(1):10-3. doi: 10.1136/bjsm.25.1.10.
- Background: PubMed 11869914Gurney B. Leg length discrepancy. Gait Posture. 2002 Apr;15(2):195-206. doi: 10.1016/s0966-6362(01)00148-5.
- Background: PubMed 8056627Dott GA, Hart CL, McKay C. Predictability of sacral base levelness based on iliac crest measurements. J Am Osteopath Assoc. 1994 May;94(5):383-90.
- Background: PubMed 8808518Riegger-Krugh C, Keysor JJ. Skeletal malalignments of the lower quarter: correlated and compensatory motions and postures. J Orthop Sports Phys Ther. 1996 Feb;23(2):164-70. doi: 10.2519/jospt.1996.23.2.164.
- BackgroundWard, R. Foundations for Osteopathic Medicine 2nd Edition. 2003, p. 614-618, 780
- BackgroundDiGiovanna, EL. Schiowitz S. An Osteopathic Approach to Diagnosis and Treatment. Philadelphia: Lippincott-Raven, 301.
- Derived from this study: PubMed 25082970Qureshi Y, Kusienski A, Bemski JL, Luksch JR, Knowles LG. Effects of somatic dysfunction on leg length and weight bearing. J Am Osteopath Assoc. 2014 Aug;114(8):620-30. doi: 10.7556/jaoa.2014.127.
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.
Andrew M Kusienski, D.O. principal investigator
Nova Southeastern 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 Somatic Dysfunctions of Pelvis and Somatic Dysfunctions of Sacrum, run by Nova Southeastern 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 4 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 24 Apr 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097109, which also lists 8 linked publications.
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 24 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.