Low Back PainNCT02427438
Home Program Education for Patients With Low Back Pain
A study testing Video and Handout in people with Low Back Pain and Lumbago, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effect size of the change in Oswestry Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based instruction or standard of care hand-out with pictures and written instructions for subjects meeting the clinical prediction rule for… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Lumbago, Spinal Instability
- What is being tested?
- Video and Handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2015
- Phase
- Interventional
- 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
Who may be able to join
- presence of aberrant movement (Gower's sign, painful arc of motion, poor reversal of lumbopelvic rhythm)
- Positive prone instability test
- Straight leg raise greater than ninety-one degrees
- Age under 40
Who cannot join
- Anyone not meeting the 3/4 clinical prediction rules
- Those unable to access video based exercise instructions
- A prior spinal fusion, tumor, infection
- Two or more neurological symptoms such as upper motor neuron signs, myotomal weakness, dermatomal sensory changes, or abnormal reflexes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Spine Physical Therapy
Madison, Wisconsin, 53711
About this study
Official title: Home Program Education for Patients With Low Back Pain: Does it Matter? A Prospective Study
The primary purpose of this study is to assess the effect size of the change in Oswestry Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based instruction or standard of care hand-out with pictures and written instructions for subjects meeting the clinical prediction rule for lumbar stabilization.
The second purpose will be to determine if there is a subset of physical examination and self-reported variables that are associated with having a successful result (ODQ improvement by at least 6 points) and if the subset of variables are affected by whether or not the subject was in the intervention (video) or control (handout) group.
Read the detailed description
Approximately fifty percent of patients seeking help in outpatient orthopedic clinics and roughly thirty percent of people will experience some low back pain (LBP) at some time in their life.(1) LBP is the second leading cause of missed days of work per year and results in around ninety billion dollars per year in medical costs. (1) Physical therapy interventions for LBP could include manual therapy, exercise, traction, range of motion, modalities, postural education, or a combination of these interventions.(2-5) Medical treatment for LBP could include medications, imaging, laboratory studies, injections, surgery, or counseling through pain psychology.(6-7) Many research studies are inconclusive regarding effective treatment.
In 1995 a treatment based classification system for patients with acute low back pain was published.(8) Patients were categorized into one of four categories: manipulation, directional exercises (flexion, extension, lateral shift correction), immobilization, or traction. (8)This classification system led to further validation of the categories and clinical prediction rules (CPR) related to best treatment outcomes.(9-11) In 2005, Hicks built upon the initial classification system for immobilization when he published a preliminary CPR identifying which patients were most likely to benefit from lumbar stabilization.(10) Hicks identified the following predictors for patient response to stabilization exercises: individuals younger than age forty, straight leg raise greater than ninety-one degrees, and aberrant motions or a positive prone instability test.(10) Hicks reported a presence of three or more of these variables had a positive likelihood ratio of 4.0 for a 95% confidence interval.(10) However, no studies to date have confirmed such results nor validated this clinical prediction rule.
Home program prescription background Evidence for using video for home program prescription is limited. However, video based home programs have been successfully used for patients with Huntington's disease, traumatic brain injury (TBI), spinal cord injury, brachial plexus injuries, and general shoulder strengthening.(12-15) Medical studies demonstrate that patients comprehend information better when communicated via educational videos as opposed to educational pamphlets about various disorders.(16-18)
Problem Statement:
Currently, there is no literature evaluating the use of video home programs for patients with LBP or identifying who may benefit from this form of clinical education. Home program handouts frequently depict photographs or figures with incorrect form or instructions. Video based home programs demonstrating the stabilization techniques for patients may provide correct form and accurate instructions. With such programs, patient comprehension and technical reproduction of the exercises may improve. Video-based home programs could lead to fewer clinic visits and decreased cost per episode of care.
Given the numerous factors that contribute to limited clinic visits in LBP patients, more effective communication should be beneficial during treatment. We do not know if patient learning styles may influence compliance with varying modes of home exercise program prescriptions. Video based home exercise programs may also be a better fit for patients who are more auditory or visual learners as defined by the Visual, Auditory, Reading, Kinesthetic (VARK) learning inventory. (19) Auditory learners prefer information being transferred by listening. Visual learners prefer maps, charts, and perhaps videos over written charts or instructions.
- Conditions
- Low Back Pain, Lumbago, Spinal Instability
- Being tested
- Video, Handout
- Keywords
- video, handout, home program, stabilization, strengthening, core
- 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.
VideoOther
A video with moving demonstration and verbal instruction of the exercise to strengthen low back
HandoutOther
A handout with a two dimensional picture and written instruction of the exercise to strengthen low back
| Study group | Role | What they receive |
|---|---|---|
| Video Home Program Education | Active comparator | Subjects in this group will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a video with verbal instruction for guidance of proper technique and repetitions. Receives: Other: Video |
| Handout Home Program Education | Active comparator | Subjects will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a handout with two dimensional pictures and written instructions for guidance of proper technique and repetitions. Receives: Other: Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Questionnaire (ODQ)
The ODQ measures level of disability with patients presenting with low back pain. It is also reliable and has excellent construct validity.(10, 34-36) The ODQ will be assessed at baseline and after eight weeks of therapy to determine the overall success of stabilization based treatment on patient function.(10) The Oswestry has ten sections, one to assess pain and the remaining which assesses functional activities. Each section is scored from 0 to 5 which indicates the level of limitation with that given activity. Each score is then totaled and then doubled to give a percentage of disability. Higher scores on the Oswestry indicate greater levels of disability. A five to six point improvement on the Oswestry is considered the minimum clinically important difference with a fifty percent improvement being defined as "success" by Hicks.
Measured: 8 weeks
Secondary outcomes (1)
Visual Analog Scale (VAS)
All subjects will complete a numeric pain rating using the traditional eleven point VAS scale. This will be assessed at every clinic visit. The VAS consists of a 100 mm line in which patients mark their pain on a scale from No Pain to Worst Pain Imaginable. This has been shown to be reliable and valid in prior research studies for low back pain. The VAS also is sensitive in detecting small amounts of change. 24 Prior research demonstrates that the repeatability of the VAS is good with correlation coefficients ranging from 0.97 to 0.99.(25) According to Jenson, the VAS also has greater levels of discrimination when using a 101 point scale.(26) Majority of research articles using the VAS define a statistically significant reduction as 50%.(26)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Why it stopped: Not recruiting subjects currently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Virag, MPT, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427438
- Sponsor's protocol ID
- 2012-0672
- Status last verified
- Oct 2017
- First submitted
- 22 Apr 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Slater SL, Ford JJ, Richards MC, Taylor NF, Surkitt LD, Hahne AJ. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Man Ther. 2012 Jun;17(3):201-12. doi: 10.1016/j.math.2012.01.006. Epub 2012 Mar 3.
PubMed 22386046Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.
PubMed 15733046Surkitt LD, Ford JJ, Hahne AJ, Pizzari T, McMeeken JM. Efficacy of directional preference management for low back pain: a systematic review. Phys Ther. 2012 May;92(5):652-65. doi: 10.2522/ptj.20100251. Epub 2012 Jan 12.
PubMed 22247407Li LC, Bombardier C. Physical therapy management of low back pain: an exploratory survey of therapist approaches. Phys Ther. 2001 Apr;81(4):1018-28.
PubMed 11276184Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. Use and costs of prescription medications and alternative treatments in patients with osteoarthritis and chronic low back pain in community-based settings. Pain Pract. 2012 Sep;12(7):550-60. doi: 10.1111/j.1533-2500.2012.00532.x. Epub 2012 Feb 5.
PubMed 22304678Rundell SD, Davenport TE. Patient education based on principles of cognitive behavioral therapy for a patient with persistent low back pain: a case report. J Orthop Sports Phys Ther. 2010 Aug;40(8):494-501. doi: 10.2519/jospt.2010.3264.
PubMed 20710087Wentz AC, Garcia SC, Klingensmith GJ, Migeon CJ, Jones GS. Gonadotropin output and response to LRH administration in congenital virilizing adrenal hyperplasia. J Clin Endocrinol Metab. 1976 Feb;42(2):239-46. doi: 10.1210/jcem-42-2-239.
PubMed 770494Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D, Butler B, Garber M, Allison S. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2835-43. doi: 10.1097/00007632-200212150-00021.
PubMed 12486357Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PubMed 16181938Fritz JM, Cleland JA, Childs JD. Subgrouping patients with low back pain: evolution of a classification approach to physical therapy. J Orthop Sports Phys Ther. 2007 Jun;37(6):290-302. doi: 10.2519/jospt.2007.2498.
PubMed 17612355Khalil H, Quinn L, van Deursen R, Dawes H, Playle R, Rosser A, Busse M. What effect does a structured home-based exercise programme have on people with Huntington's disease? A randomized, controlled pilot study. Clin Rehabil. 2013 Jul;27(7):646-58. doi: 10.1177/0269215512473762. Epub 2013 Feb 20.
PubMed 23426565Betker AL, Desai A, Nett C, Kapadia N, Szturm T. Game-based exercises for dynamic short-sitting balance rehabilitation of people with chronic spinal cord and traumatic brain injuries. Phys Ther. 2007 Oct;87(10):1389-98. doi: 10.2522/ptj.20060229. Epub 2007 Aug 21.
PubMed 17712036Murphy KM, Rasmussen L, Hervey-Jumper SL, Justice D, Nelson VS, Yang LJ. An assessment of the compliance and utility of a home exercise DVD for caregivers of children and adolescents with brachial plexus palsy: a pilot study. PM R. 2012 Mar;4(3):190-7. doi: 10.1016/j.pmrj.2011.08.538. Epub 2011 Nov 16.
PubMed 22088854Reo JA, Mercer VS. Effects of live, videotaped, or written instruction on learning an upper-extremity exercise program. Phys Ther. 2004 Jul;84(7):622-33.
PubMed 15225081Armstrong AW, Kim RH, Idriss NZ, Larsen LN, Lio PA. Online video improves clinical outcomes in adults with atopic dermatitis: a randomized controlled trial. J Am Acad Dermatol. 2011 Mar;64(3):502-7. doi: 10.1016/j.jaad.2010.01.051. Epub 2011 Jan 13.
PubMed 21236514
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Program Education for Patients With Low Back Pain: Does it Matter? A Prospective Study
- ClinicalTrials.gov ID
- NCT02427438
- Acronym / sponsor ID
- 2012-0672
- Conditions
- Low Back Pain, Lumbago, Spinal Instability
- Keywords
- video, handout, home program, stabilization, strengthening, core
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not recruiting subjects currently
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 28 Apr 2015 (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 primary purpose of this study is to assess the effect size of the change in Oswestry Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based instruction or standard of care hand-out with pictures and written instructions for subjects meeting the clinical prediction rule for lumbar stabilization.
The second purpose will be to determine if there is a subset of physical examination and self-reported variables that are associated with having a successful result (ODQ improvement by at least 6 points) and if the subset of variables are affected by whether or not the subject was in the intervention (video) or control (handout) group.
Detailed description
Approximately fifty percent of patients seeking help in outpatient orthopedic clinics and roughly thirty percent of people will experience some low back pain (LBP) at some time in their life.(1) LBP is the second leading cause of missed days of work per year and results in around ninety billion dollars per year in medical costs. (1) Physical therapy interventions for LBP could include manual therapy, exercise, traction, range of motion, modalities, postural education, or a combination of these interventions.(2-5) Medical treatment for LBP could include medications, imaging, laboratory studies, injections, surgery, or counseling through pain psychology.(6-7) Many research studies are inconclusive regarding effective treatment.
In 1995 a treatment based classification system for patients with acute low back pain was published.(8) Patients were categorized into one of four categories: manipulation, directional exercises (flexion, extension, lateral shift correction), immobilization, or traction. (8)This classification system led to further validation of the categories and clinical prediction rules (CPR) related to best treatment outcomes.(9-11) In 2005, Hicks built upon the initial classification system for immobilization when he published a preliminary CPR identifying which patients were most likely to benefit from lumbar stabilization.(10) Hicks identified the following predictors for patient response to stabilization exercises: individuals younger than age forty, straight leg raise greater than ninety-one degrees, and aberrant motions or a positive prone instability test.(10) Hicks reported a presence of three or more of these variables had a positive likelihood ratio of 4.0 for a 95% confidence interval.(10) However, no studies to date have confirmed such results nor validated this clinical prediction rule.
Home program prescription background Evidence for using video for home program prescription is limited. However, video based home programs have been successfully used for patients with Huntington's disease, traumatic brain injury (TBI), spinal cord injury, brachial plexus injuries, and general shoulder strengthening.(12-15) Medical studies demonstrate that patients comprehend information better when communicated via educational videos as opposed to educational pamphlets about various disorders.(16-18)
Problem Statement:
Currently, there is no literature evaluating the use of video home programs for patients with LBP or identifying who may benefit from this form of clinical education. Home program handouts frequently depict photographs or figures with incorrect form or instructions. Video based home programs demonstrating the stabilization techniques for patients may provide correct form and accurate instructions. With such programs, patient comprehension and technical reproduction of the exercises may improve. Video-based home programs could lead to fewer clinic visits and decreased cost per episode of care.
Given the numerous factors that contribute to limited clinic visits in LBP patients, more effective communication should be beneficial during treatment. We do not know if patient learning styles may influence compliance with varying modes of home exercise program prescriptions. Video based home exercise programs may also be a better fit for patients who are more auditory or visual learners as defined by the Visual, Auditory, Reading, Kinesthetic (VARK) learning inventory. (19) Auditory learners prefer information being transferred by listening. Visual learners prefer maps, charts, and perhaps videos over written charts or instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Home Program Education | Active comparator | Other: VideoSubjects in this group will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a video with verbal instruction for guidance of proper technique and repetitions. |
| Handout Home Program Education | Active comparator | Other: HandoutSubjects will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a handout with two dimensional pictures and written instructions for guidance of proper technique and repetitions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- presence of aberrant movement (Gower's sign, painful arc of motion, poor reversal of lumbopelvic rhythm)
- Positive prone instability test
- Straight leg raise greater than ninety-one degrees
- Age under 40
Key exclusion criteria (4 listed)
- Anyone not meeting the 3/4 clinical prediction rules
- Those unable to access video based exercise instructions
- A prior spinal fusion, tumor, infection
- Two or more neurological symptoms such as upper motor neuron signs, myotomal weakness, dermatomal sensory changes, or abnormal reflexes
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 |
|---|---|---|
| VideoA video with moving demonstration and verbal instruction of the exercise to strengthen low back | Other | Video Home Program Education |
| HandoutA handout with a two dimensional picture and written instruction of the exercise to strengthen low back | Other | Handout Home Program Education |
Primary outcome
Oswestry Disability Questionnaire (ODQ)
Time frame: 8 weeks
The ODQ measures level of disability with patients presenting with low back pain. It is also reliable and has excellent construct validity.(10, 34-36) The ODQ will be assessed at baseline and after eight weeks of therapy to determine the overall success of stabilization based treatment on patient function.(10) The Oswestry has ten sections, one to assess pain and the remaining which assesses functional activities. Each section is scored from 0 to 5 which indicates the level of limitation with that given activity. Each score is then totaled and then doubled to give a percentage of disability. Higher scores on the Oswestry indicate greater levels of disability. A five to six point improvement on the Oswestry is considered the minimum clinically important difference with a fifty percent improvement being defined as "success" by Hicks.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: 8 weeks
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 26 Oct 2017.
- Results publication: PubMed 22386046Slater SL, Ford JJ, Richards MC, Taylor NF, Surkitt LD, Hahne AJ. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Man Ther. 2012 Jun;17(3):201-12. doi: 10.1016/j.math.2012.01.006. Epub 2012 Mar 3.
- Results publication: PubMed 15733046Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.
- Results publication: PubMed 22247407Surkitt LD, Ford JJ, Hahne AJ, Pizzari T, McMeeken JM. Efficacy of directional preference management for low back pain: a systematic review. Phys Ther. 2012 May;92(5):652-65. doi: 10.2522/ptj.20100251. Epub 2012 Jan 12.
- Results publication: PubMed 11276184Li LC, Bombardier C. Physical therapy management of low back pain: an exploratory survey of therapist approaches. Phys Ther. 2001 Apr;81(4):1018-28.
- Results publication: PubMed 22304678Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. Use and costs of prescription medications and alternative treatments in patients with osteoarthritis and chronic low back pain in community-based settings. Pain Pract. 2012 Sep;12(7):550-60. doi: 10.1111/j.1533-2500.2012.00532.x. Epub 2012 Feb 5.
- Results publication: PubMed 20710087Rundell SD, Davenport TE. Patient education based on principles of cognitive behavioral therapy for a patient with persistent low back pain: a case report. J Orthop Sports Phys Ther. 2010 Aug;40(8):494-501. doi: 10.2519/jospt.2010.3264.
- Results publication: PubMed 770494Wentz AC, Garcia SC, Klingensmith GJ, Migeon CJ, Jones GS. Gonadotropin output and response to LRH administration in congenital virilizing adrenal hyperplasia. J Clin Endocrinol Metab. 1976 Feb;42(2):239-46. doi: 10.1210/jcem-42-2-239.
- Results publication: PubMed 12486357Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D, Butler B, Garber M, Allison S. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2835-43. doi: 10.1097/00007632-200212150-00021.
- Results publication: PubMed 16181938Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
- Results publication: PubMed 17612355Fritz JM, Cleland JA, Childs JD. Subgrouping patients with low back pain: evolution of a classification approach to physical therapy. J Orthop Sports Phys Ther. 2007 Jun;37(6):290-302. doi: 10.2519/jospt.2007.2498.
- Results publication: PubMed 23426565Khalil H, Quinn L, van Deursen R, Dawes H, Playle R, Rosser A, Busse M. What effect does a structured home-based exercise programme have on people with Huntington's disease? A randomized, controlled pilot study. Clin Rehabil. 2013 Jul;27(7):646-58. doi: 10.1177/0269215512473762. Epub 2013 Feb 20.
- Results publication: PubMed 17712036Betker AL, Desai A, Nett C, Kapadia N, Szturm T. Game-based exercises for dynamic short-sitting balance rehabilitation of people with chronic spinal cord and traumatic brain injuries. Phys Ther. 2007 Oct;87(10):1389-98. doi: 10.2522/ptj.20060229. Epub 2007 Aug 21.
- American Pain FoundationLink provided by the sponsor.
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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.
Tiffany Virag, MPT principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Handout in people with Low Back Pain and Lumbago, run by University of Wisconsin, Madison 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 4 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: withdrawn, as of the sponsor's last update on 26 Oct 2017. 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?
Oswestry Disability Questionnaire (ODQ) (time frame: 8 weeks). 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 NCT02427438, which also lists 34 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 26 Oct 2017.