Low Back PainNCT03040310
Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain
A study testing Back Rx program in people with Low Back Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The prevalence and disability associated with discogenic low back pain are significant, and there is a general lack of widely accepted conservative treatments for the condition. A majority of previous studies that have assessed the efficacy of self-directed exercise-based rehabilitation programs did not include… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Back Rx program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain with predominantly axial symptoms (axial pain > leg pain) that are exacerbated with sitting and alleviated with walking
- Persistence of symptoms for at least 3 months
- Lumbar intervertebral disc pathology evident on magnetic resonance imaging
- 18 to 65 years old
- Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up)
- English speaking
Who cannot join
- Concurrent pathology that may contribute to patients' axial low back symptoms (e.g., spondylolysis, spondylolisthesis, facet arthropathy)
- Severe lumbar disc degeneration prior to beginning Back Rx exercise program
- History of lumbar spine surgery or other interventions prior to beginning Back Rx exercise program
- History of trauma
- Cases involving workers' compensation or other legal claims
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Personalized Back Rx Exercise Program With Coaching, Social Support, and Sensor-assisted Assessments as a Treatment for Discogenic Low Back Pain: A Prospective Pilot Study
The prevalence and disability associated with discogenic low back pain are significant, and there is a general lack of widely accepted conservative treatments for the condition. A majority of previous studies that have assessed the efficacy of self-directed exercise-based rehabilitation programs did not include comprehensive metrics to confirm whether participants actually participated in the exercises prescribed. In this pilot study, the investigators hope to determine whether proxies of compliance with a daily, self-directed rehabilitation program for discogenic low back pain are correlated with participant-reported improvements in pain and function. The feasibility of a mobile interface designed to help patients with chronic low back pain track the daily management of their conditions will also be evaluated.
- Conditions
- Low Back Pain
- Being tested
- Back Rx program
- 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.
Back Rx programOther
The Back Rx program can be viewed via a smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| Back Rx program | Experimental | Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos. Receives: Other: Back Rx program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.
Measured: Up to 12 months post-program start
Secondary outcomes (4)
Compliance with app/program
Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed
Measured: Up to 12 months post-program start
Satisfaction with program
Participants will be asked whether they would recommend the app to a friend.
Measured: Up to 12 months post-program start
Medication utilization
Usage of medications will be documented
Measured: Up to 3 months post-program start
Pain score
Pain will be assessed via the visual analog scale
Measured: Up to 12 months post-program start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell Tech, UnitedHealth Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040310
- Sponsor's protocol ID
- 2016-020
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vad VB, Madrazo-Ibarra A, Estrin D, Pollak JP, Carroll KM, Vojta D, Vad A, Trapness C. "Back Rx, a personalized mobile phone application for discogenic chronic low back pain: a prospective pilot study". BMC Musculoskelet Disord. 2022 Oct 19;23(1):923. doi: 10.1186/s12891-022-05883-9.
PubMed 36261825Selter A, Tsangouri C, Ali SB, Freed D, Vatchinsky A, Kizer J, Sahuguet A, Vojta D, Vad V, Pollak JP, Estrin D. An mHealth App for Self-Management of Chronic Lower Back Pain (Limbr): Pilot Study. JMIR Mhealth Uhealth. 2018 Sep 17;6(9):e179. doi: 10.2196/mhealth.8256.
PubMed 30224333
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Back Rx Exercise Program With Coaching, Social Support, and Sensor-assisted Assessments as a Treatment for Discogenic Low Back Pain: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03040310
- Acronym / sponsor ID
- 2016-020
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Cornell Tech, UnitedHealth Group
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Feb 2017 (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 prevalence and disability associated with discogenic low back pain are significant, and there is a general lack of widely accepted conservative treatments for the condition. A majority of previous studies that have assessed the efficacy of self-directed exercise-based rehabilitation programs did not include comprehensive metrics to confirm whether participants actually participated in the exercises prescribed. In this pilot study, the investigators hope to determine whether proxies of compliance with a daily, self-directed rehabilitation program for discogenic low back pain are correlated with participant-reported improvements in pain and function. The feasibility of a mobile interface designed to help patients with chronic low back pain track the daily management of their conditions will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Back Rx program | Experimental | Other: Back Rx programStudy patients will use their smartphone apps to view their Back Rx program content, exercises, and videos. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Low back pain with predominantly axial symptoms (axial pain > leg pain) that are exacerbated with sitting and alleviated with walking
- Persistence of symptoms for at least 3 months
- Lumbar intervertebral disc pathology evident on magnetic resonance imaging
- 18 to 65 years old
- Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up)
Key exclusion criteria (6 listed)
- Concurrent pathology that may contribute to patients' axial low back symptoms (e.g., spondylolysis, spondylolisthesis, facet arthropathy)
- Severe lumbar disc degeneration prior to beginning Back Rx exercise program
- History of lumbar spine surgery or other interventions prior to beginning Back Rx exercise program
- History of trauma
- Cases involving workers' compensation or other legal claims
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 |
|---|---|---|
| Back Rx programThe Back Rx program can be viewed via a smartphone app. | Other | Back Rx program |
Primary outcome
Oswestry Disability Index
Time frame: Up to 12 months post-program start
The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.
4 secondary outcomes
Compliance with app/program
Time frame: Up to 12 months post-program start
Satisfaction with program
Time frame: Up to 12 months post-program start
Medication utilization
Time frame: Up to 3 months post-program start
Pain score
Time frame: Up to 12 months post-program start
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 8 Feb 2018.
- Derived from this study: PubMed 36261825Vad VB, Madrazo-Ibarra A, Estrin D, Pollak JP, Carroll KM, Vojta D, Vad A, Trapness C. "Back Rx, a personalized mobile phone application for discogenic chronic low back pain: a prospective pilot study". BMC Musculoskelet Disord. 2022 Oct 19;23(1):923. doi: 10.1186/s12891-022-05883-9.
- Derived from this study: PubMed 30224333Selter A, Tsangouri C, Ali SB, Freed D, Vatchinsky A, Kizer J, Sahuguet A, Vojta D, Vad V, Pollak JP, Estrin D. An mHealth App for Self-Management of Chronic Lower Back Pain (Limbr): Pilot Study. JMIR Mhealth Uhealth. 2018 Sep 17;6(9):e179. doi: 10.2196/mhealth.8256.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back Rx program in people with Low Back Pain, run by Hospital for Special Surgery, New York 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 6 inclusion and 6 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Up to 12 months post-program start). 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 NCT03040310, which also lists 2 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 8 Feb 2018.