Low Back PainNCT02201966
Regional Interdependence of the Shoulders and Hips in Gymnasts With Low Back Pain
An observational study of Low Back Pain, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Low back pain is a common condition in children who perform gymnastics. Commonly, the injury is not the result of a specific injury, but is a stress injury to the lumbar spine. Regional interdependence is a theory that suggests when adjacent joints and muscles are not working properly increased stress is placed on a… Read more about this study
- Who is it for?
- Ages 7 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2015
- 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 7 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Competitive female gymnasts. Females who perform gymnastics at local gymnastics training centers.
Who may be able to join
- At least 7 years old
- Level 5 or higher gymnast
- Female
Who cannot join
- Patient with a injury to the shoulder, or hips that prevents them from performing gymnastics.
- Patients who are unable to follow directions.
Trial locations and contacts
1 site in 1 country.
About this study
Low back pain is a common condition in children who perform gymnastics. Commonly, the injury is not the result of a specific injury, but is a stress injury to the lumbar spine. Regional interdependence is a theory that suggests when adjacent joints and muscles are not working properly increased stress is placed on a particular joint. This theory would suggest that if a patient did not have enough hip extension to perform a back bend increased motion would occur in the lumbar spine allowing the gymnast to complete the technique. Currently, no research links impairments in other joints to low back pain in gymnasts.
This is a cross sectional study assessing the relationship between gymnast with back pain and flexibility and strength of the shoulder and hip joints. Investigators will travel to a local gymnastics training centers and assess the gymnasts' strength and flexibility of the the hips and shoulders. The gymnast will also fill our a questionnaire assessing if they have had back pain in the past month and how much has it limited their ability to participate in gymnastics. Investigators will be blinded to the results of this survey.
The goal of this research study is to see if there are any link between strength and flexibility of the hips, and shoulders and gymnasts with low back pain. The investigators hypothesize that gymnasts who demonstrates impairments in strength and flexibility of the hips, or shoulders will be more likely to have complaints of low back pain.
Read the detailed description
Female gymnasts will fill out a survey prior having their strength and flexibility tested. The investigators will be blinded to the results of the survey.
The questionaire asked the gymnasts several questions:
- Age
- Years in Gymnastics
- At what level did you last compete?
- On average how many hours per week do you participate in gymnastics?
- Have you had any back pain in the past month that has affected your ability to participate in gymnastics?
- If you answered yes to the last question: please rate your ability to participate in gymnastics with back pain?(0 represents unable to perform gymnastics and 100 represents no difficulty participating in gymnastics
After the gymnast complete the survey the investigators will assess the flexibility and strength of their shoulder and hip muscles. Investigators will be blinded to survey results. Evaluation measures will be performed in a randomized manner. Subjects will randomly perform shoulder or hip testing first (determined by flip of coin). Flexibility and strength testing will also be determined randomly (determined by flip of coin).
Evaluation measures
Shoulder Flexibility Passive Motion test:
- Prior to shoulder flexibility testing, the gymnast's arm length is measured from the tip of the acromion process to a ½ inch wooden dowel grasped by both hands while holding their shoulders flexed to 90 degrees.
- For testing, the gymnast lies prone on a firm floor with their chin and nose touching the floor.
- Both arms are held parallel to the body with the shoulders flexed to 180 degrees.
- The gymnast grasps the ½ inch dowel with and overhand grip and the tips of her thumbs are touching.
- The evaluator maximally flexes the gymnasts shoulders while maintaining wrist in neutral position, elbows extended and their nose and chin in contact with the floor.
- Once the gymnast's arms are raised to maximum height, the distance from the dowel, where the thumbs are touching, to the floor is measured and recorded to the nearest ½ centimeter using a rigid measuring stick.
- The Shoulder flexibility Passive Motion test raw score is calculated my dividing the dowel height attained by the length of the gymnast's arm.
Shoulder Flexibility Active Motion test:
- Prior to shoulder flexibility testing, the gymnast's arm length is measured from the tip of the acromion process to a ½ inch wooden dowel grasped by both hands while holding their shoulders flexed to 90 degrees.
- For testing, the gymnast lies prone on a firm floor with their chin and nose touching the floor.
- Both arms are held parallel to the body with the shoulders flexed to 180 degrees.
- The gymnast grasps the ½ inch dowel with and overhand grip and the tips of her thumbs are touching.
- The gymnast is asked to maximally flex their shoulders while maintaining wrist in neutral position, elbows extended and their nose and chin in contact with the floor.
- Once the gymnast has raised their arms to the maximum height, the distance from the dowel, where the thumbs are touching, to the floor is measured and recorded to the nearest ½ centimeter using a rigid measuring stick.
- The Shoulder flexibility test raw score is calculated my dividing the dowel height attained by the length of the gymnast's arm.
Hip Extension Flexibility test (Thomas test):
- Prior to hip extension flexibility testing, the gymnast lays flat on the examination table with legs extended. The examiner places the digital inclinometer on the anterior portion of the mid-thigh and zeros the inclinometer. The examiner marks the gymnast's skin at the distal most portion of the inclinometer in contact with the gymnast.
- Hip extension flexibility will be measured by using the modified Thomas test.
- The gymnast is instructed to sit as close to the edge of the examination table as possible.
- The gymnast supports their contralateral thigh with their arms and, with the assistance of the examiner, slowly rolls backward onto the table.
- The contralateral hip is flexed to the point that the gymnast's lumbar lordosis is flattened, and the right limb is allowed to hang unsupported off the table.
- The examiner palpates the lumbar spine to confirm that it remains in contact with the table.
- Thigh position is also monitored to prevent abduction of the thigh.
- When the final test position is achieved the examiner places the inclinometer on the gymnast's anterior thigh in line made prior to testing.
- 0 degrees indicates the gymnast's thigh is parallel to the horizon. If the thigh was above horizontal the number from the digital inclinometer will be read as negative. If the thigh is below horizontal the number will be positive.
Dynamometer Testing:
After having received standardized instructions, subjects will perform a series of familiarization trials consisting of three submaximal contractions per side. Then maximal voluntary contraction strength will be measured. The side tested first will be randomized within each test session. All maximal voluntary contraction strength data provided by the dynamometer (in kilograms) will be normalized to body weight.
Shoulder Flexion Strength test:
- Strength testing will be performed with hand held dynamometer stabilized by the examiner.
- For testing, the gymnast lies prone on a firm floor with their chin and nose touching the floor.
- Both arms are held parallel to the body with the shoulders flexed to 180 degrees.
- The gymnast grasps the ½ inch dowel with and overhand grip and the tips of her thumbs are touching.
- The dynamometer pad will be will located on the ½ inch dowel where the gymnasts thumbs meet.
- The gymnast is asked to maximally flex their shoulders pressing the dowel into the dynamometer pad as hard as they can while maintaining wrist in neutral position, elbows extended and their nose and chin in contact with the floor.
- Two to three maximal voluntary contraction trials will be permitted. A third trial is completed only if the difference between the first two maximal voluntary contractions is >10%.
- The duration of these contractions will be 5 seconds, and thirty seconds of rest will be given between trials.
- If gymnast is unable to actively flex shoulders to 180 degrees the strength test will be scored as 0.
Isometric maximal voluntary contraction strength of the hip muscles will be measured with a portable dynamometer fixed to a custom made frame. The custom-made frame is firmly fixed to a physical therapy treatment table with use of screw clamps. The frame consisted of two vertical bars and 1 horizontal bar attached to the vertical bars so as to be perpendicular to the extremities. The dynamometer is fixed to the horizontal bar so as the testing pad can be positioned properly for testing.
.
Hip Extension Strength Dynamometer Test:
- Gymnast is in prone position on examination table with tested leg knee fully extended. Tested hip is in 5 degrees of extension with the knee in full extension.
- The dynamometer is fixed using the custom made frame
- The center of the dynamometer pad will be on the posterior aspect of the calcaneus
- Gymnast is told to stabilize themselves by holding onto the examination table
- Gymnasts is instructed to push as hard as they can against the dynamometer testing pad.
- Two to three maximal voluntary contraction trials will be permitted. A third trial is completed only if the difference between the first two maximal voluntary contractions is >10%.
- The duration of these contractions will be 5 seconds, and thirty seconds of rest will be given between trials.
Hip Abduction Strength Dynamometer test:
- Gymnast is in sidelying position on examination table with tested leg knee fully extended.
- The contralateral hip and knee joints will be positioned at approximately 30 degrees of flexion for stability and comfort.
- Tested hip is in 10 degrees of abduction with the knee in full extension. •. The center of the dynamometer pad will be located 5 cm proximal to the lateral femoral condyle.
- Gymnast is told to stabilize themselves by holding onto the examination table.
- Gymnast is instructed to push as hard as they can against the dynamometer testing pad.
- The examiner will inspect the whole body position during the maximal voluntary contraction trials to ensure minimal compensation from pelvic rotation and flexion and rotation about the hip. If the examiner judges too much compensation, that test will not be recorded and the subject will be reinstructed in proper testing form.
- Two to three maximal voluntary contraction trials will be permitted. A third trial is completed only if the difference between the first two maximal voluntary contractions is >10%.
- The duration of these contractions will be 5 seconds, and thirty seconds of rest will be given between trials.
- Conditions
- Low Back Pain
- Keywords
- low back pain, pediatric, gymnasts
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female gymnasts with low back pain | Subset of competitive female gymnasts who report significant low back pain that affects their ability to perform gymnastics. | |
| Female gymnasts without low back pain | Subset of competitive female gymnasts who deny significant low back pain that affects their ability to perform gymnastics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of low back pain in past month
Presence of significant low back pain that has affected gymnastics ability at time of evaluation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Nationwide Children's 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Selhorst, Nationwide Children's Hospital
- Investigators
- Mitchell C Selhorst, DPT, Principal investigator, Nationwide Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201966
- Sponsor's protocol ID
- IRB14-00229
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2014
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thorborg K, Petersen J, Magnusson SP, Holmich P. Clinical assessment of hip strength using a hand-held dynamometer is reliable. Scand J Med Sci Sports. 2010 Jun;20(3):493-501. doi: 10.1111/j.1600-0838.2009.00958.x. Epub 2009 Jun 23.
PubMed 19558384Sleeper MD, Kenyon LK, Casey E. Measuring fitness in female gymnasts: the gymnastics functional measurement tool. Int J Sports Phys Ther. 2012 Apr;7(2):124-38.
PubMed 22530187Widler KS, Glatthorn JF, Bizzini M, Impellizzeri FM, Munzinger U, Leunig M, Maffiuletti NA. Assessment of hip abductor muscle strength. A validity and reliability study. J Bone Joint Surg Am. 2009 Nov;91(11):2666-72. doi: 10.2106/JBJS.H.01119.
PubMed 19884441
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Interdependence of the Shoulders and Hips in Gymnasts With Low Back Pain
- ClinicalTrials.gov ID
- NCT02201966
- Acronym / sponsor ID
- IRB14-00229
- Conditions
- Low Back Pain
- Keywords
- low back pain, pediatric, gymnasts
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Jul 2014 (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.
Low back pain is a common condition in children who perform gymnastics. Commonly, the injury is not the result of a specific injury, but is a stress injury to the lumbar spine. Regional interdependence is a theory that suggests when adjacent joints and muscles are not working properly increased stress is placed on a particular joint. This theory would suggest that if a patient did not have enough hip extension to perform a back bend increased motion would occur in the lumbar spine allowing the gymnast to complete the technique. Currently, no research links impairments in other joints to low back pain in gymnasts.
This is a cross sectional study assessing the relationship between gymnast with back pain and flexibility and strength of the shoulder and hip joints. Investigators will travel to a local gymnastics training centers and assess the gymnasts' strength and flexibility of the the hips and shoulders. The gymnast will also fill our a questionnaire assessing if they have had back pain in the past month and how much has it limited their ability to participate in gymnastics. Investigators will be blinded to the results of this survey.
The goal of this research study is to see if there are any link between strength and flexibility of the hips, and shoulders and gymnasts with low back pain. The investigators hypothesize that gymnasts who demonstrates impairments in strength and flexibility of the hips, or shoulders will be more likely to have complaints of low back pain.
Detailed description
Female gymnasts will fill out a survey prior having their strength and flexibility tested. The investigators will be blinded to the results of the survey.
The questionaire asked the gymnasts several questions:
- Age
- Years in Gymnastics
- At what level did you last compete?
- On average how many hours per week do you participate in gymnastics?
- Have you had any back pain in the past month that has affected your ability to participate in gymnastics?
- If you answered yes to the last question: please rate your ability to participate in gymnastics with back pain?(0 represents unable to perform gymnastics and 100 represents no difficulty participating in gymnastics
After the gymnast complete the survey the investigators will assess the flexibility and strength of their shoulder and hip muscles. Investigators will be blinded to survey results. Evaluation measures will be performed in a randomized manner. Subjects will randomly perform shoulder or hip testing first (determined by flip of coin). Flexibility and strength testing will also be determined randomly (determined by flip of coin).
Evaluation measures
Shoulder Flexibility Passive Motion test:
- Prior to shoulder flexibility testing, the gymnast's arm length is measured from the tip of the acromion process to a ½ inch wooden dowel grasped by both hands while holding their shoulders flexed to 90 degrees.
- For testing, the gymnast lies prone on a firm floor with their chin and nose touching the floor.
- Both arms are held parallel to the body with the shoulders flexed to 180 degrees.
- The gymnast grasps the ½ inch dowel with and overhand grip and the tips of her thumbs are touching.
- The evaluator maximally flexes the gymnasts shoulders while maintaining wrist in neutral position, elbows extended and their nose and chin in contact with the floor.
- Once the gymnast's arms are raised to maximum height, the distance from the dowel, where the thumbs are touching, to the floor is measured and recorded to the nearest ½ centimeter using a rigid measuring stick.
- The Shoulder flexibility Passive Motion test raw score is calculated my dividing the dowel height attained by the length of the gymnast's arm.
Shoulder Flexibility Active Motion test:
- Prior to shoulder flexibility testing, the gymnast's arm length is measured from the tip of the acromion process to a ½ inch wooden dowel grasped by both hands while holding their shoulders flexed to 90 degrees.
- For testing, the gymnast lies prone on a firm floor with their chin and nose touching the floor.
- Both arms are held parallel to the body with the shoulders flexed to 180 degrees.
- The gymnast grasps the ½ inch dowel with and overhand grip and the tips of her thumbs are touching.
- The gymnast is asked to maximally flex their shoulders while maintaining wrist in neutral position, elbows extended and their nose and chin in contact with the floor.
- Once the gymnast has raised their arms to the maximum height, the distance from the dowel, where the thumbs are touching, to the floor is measured and recorded to the nearest ½ centimeter using a rigid measuring stick.
- The Shoulder flexibility test raw score is calculated my dividing the dowel height attained by the length of the gymnast's arm.
Hip Extension Flexibility test (Thomas test):
- Prior to hip extension flexibility testing, the gymnast lays flat on the examination table with legs extended. The examiner places the digital inclinometer on the anterior portion of the mid-thigh and zeros the inclinometer. The examiner marks the gymnast's skin at the distal most portion of the inclinometer in contact with the gymnast.
- Hip extension flexibility will be measured by using the modified Thomas test.
- The gymnast is instructed to sit as close to the edge of the examination table as possible.
- The gymnast supports their contralateral thigh with their arms and, with the assistance of the examiner, slowly rolls backward onto the table.
- The contralateral hip is flexed to the point that the gymnast's lumbar lordosis is flattened, and the right limb is allowed to hang unsupported off the table.
- The examiner palpates the lumbar spine to confirm that it remains in contact with the table.
- Thigh position is also monitored to prevent abduction of the thigh.
- When the final test position is achieved the examiner places the inclinometer on the gymnast's anterior thigh in line made prior to testing.
- 0 degrees indicates the gymnast's thigh is parallel to the horizon. If the thigh was above horizontal the number from the digital inclinometer will be read as negative. If the thigh is below horizontal the number will be positive.
Dynamometer Testing:
After having received standardized instructions, subjects will perform a series of familiarization trials consisting of three submaximal contractions per side. Then maximal voluntary contraction strength will be measured. The side tested first will be randomized within each test session. All maximal voluntary contraction strength data provided by the dynamometer (in kilograms) will be normalized to body weight.
Shoulder Flexion Strength test:
- Strength testing will be performed with hand held dynamometer stabilized by the examiner.
- For testing, the gymnast lies prone on a firm floor with their chin and nose touching the floor.
- Both arms are held parallel to the body with the shoulders flexed to 180 degrees.
- The gymnast grasps the ½ inch dowel with and overhand grip and the tips of her thumbs are touching.
- The dynamometer pad will be will located on the ½ inch dowel where the gymnasts thumbs meet.
- The gymnast is asked to maximally flex their shoulders pressing the dowel into the dynamometer pad as hard as they can while maintaining wrist in neutral position, elbows extended and their nose and chin in contact with the floor.
- Two to three maximal voluntary contraction trials will be permitted. A third trial is completed only if the difference between the first two maximal voluntary contractions is >10%.
- The duration of these contractions will be 5 seconds, and thirty seconds of rest will be given between trials.
- If gymnast is unable to actively flex shoulders to 180 degrees the strength test will be scored as 0.
Isometric maximal voluntary contraction strength of the hip muscles will be measured with a portable dynamometer fixed to a custom made frame. The custom-made frame is firmly fixed to a physical therapy treatment table with use of screw clamps. The frame consisted of two vertical bars and 1 horizontal bar attached to the vertical bars so as to be perpendicular to the extremities. The dynamometer is fixed to the horizontal bar so as the testing pad can be positioned properly for testing.
.
Hip Extension Strength Dynamometer Test:
- Gymnast is in prone position on examination table with tested leg knee fully extended. Tested hip is in 5 degrees of extension with the knee in full extension.
- The dynamometer is fixed using the custom made frame
- The center of the dynamometer pad will be on the posterior aspect of the calcaneus
- Gymnast is told to stabilize themselves by holding onto the examination table
- Gymnasts is instructed to push as hard as they can against the dynamometer testing pad.
- Two to three maximal voluntary contraction trials will be permitted. A third trial is completed only if the difference between the first two maximal voluntary contractions is >10%.
- The duration of these contractions will be 5 seconds, and thirty seconds of rest will be given between trials.
Hip Abduction Strength Dynamometer test:
- Gymnast is in sidelying position on examination table with tested leg knee fully extended.
- The contralateral hip and knee joints will be positioned at approximately 30 degrees of flexion for stability and comfort.
- Tested hip is in 10 degrees of abduction with the knee in full extension. •. The center of the dynamometer pad will be located 5 cm proximal to the lateral femoral condyle.
- Gymnast is told to stabilize themselves by holding onto the examination table.
- Gymnast is instructed to push as hard as they can against the dynamometer testing pad.
- The examiner will inspect the whole body position during the maximal voluntary contraction trials to ensure minimal compensation from pelvic rotation and flexion and rotation about the hip. If the examiner judges too much compensation, that test will not be recorded and the subject will be reinstructed in proper testing form.
- Two to three maximal voluntary contraction trials will be permitted. A third trial is completed only if the difference between the first two maximal voluntary contractions is >10%.
- The duration of these contractions will be 5 seconds, and thirty seconds of rest will be given between trials.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female gymnasts with low back pain | – | –Subset of competitive female gymnasts who report significant low back pain that affects their ability to perform gymnastics. |
| Female gymnasts without low back pain | – | –Subset of competitive female gymnasts who deny significant low back pain that affects their ability to perform gymnastics. |
Who may qualify
- Ages
- 7 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Competitive female gymnasts. Females who perform gymnastics at local gymnastics training centers.
Key inclusion criteria (3 listed)
- At least 7 years old
- Level 5 or higher gymnast
- Female
Key exclusion criteria (2 listed)
- Patient with a injury to the shoulder, or hips that prevents them from performing gymnastics.
- Patients who are unable to follow directions.
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
Presence of low back pain in past month
Time frame: Baseline
Presence of significant low back pain that has affected gymnastics ability at time of evaluation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Background: PubMed 19558384Thorborg K, Petersen J, Magnusson SP, Holmich P. Clinical assessment of hip strength using a hand-held dynamometer is reliable. Scand J Med Sci Sports. 2010 Jun;20(3):493-501. doi: 10.1111/j.1600-0838.2009.00958.x. Epub 2009 Jun 23.
- Background: PubMed 22530187Sleeper MD, Kenyon LK, Casey E. Measuring fitness in female gymnasts: the gymnastics functional measurement tool. Int J Sports Phys Ther. 2012 Apr;7(2):124-38.
- Background: PubMed 19884441Widler KS, Glatthorn JF, Bizzini M, Impellizzeri FM, Munzinger U, Leunig M, Maffiuletti NA. Assessment of hip abductor muscle strength. A validity and reliability study. J Bone Joint Surg Am. 2009 Nov;91(11):2666-72. doi: 10.2106/JBJS.H.01119.
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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.
Mitchell C Selhorst, DPT principal investigator
Nationwide Childrens Hospital
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 Low Back Pain, run by Nationwide Children's Hospital 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 3 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: withdrawn, as of the sponsor's last update on 7 Jul 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Presence of low back pain in past month (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201966, which also lists 3 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 7 Jul 2015.