Back Pain Without RadiationNCT03449160
Postural Training Device (UPRIGHT) for Back Pain
A study testing UPRIGHT and physical therapy in people with Back Pain Without Radiation and Back Pain, Low, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain Without Radiation, Back Pain, Low
- What is being tested?
- UPRIGHT and physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 1 Feb 2022
- 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
- Age 18 - 65, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, and capable of attending all planned therapy sessions
- Primary complaint of lumbar or thoracic pain thought to be at least in part due to mechanical/postural etiologies based on clinical presentation
- 7 day average numeric pain rating score (NPRS) of at least 4 on a 0-10 scale at baseline evaluation
- Pain duration of at least 2 months
- Patient owns and is familiar with the use of a personal smart phone
- Patient consents to treatment with postural based physical therapy. In order to maintain blinding, patients will not be provided with details of the treatment plan until after the randomization process has been performed. They will only be informed of the treatment protocol for the group to which they have been assigned.
Who cannot join
- *History of prior thoracic or lumbar fusion surgery
- Acute Spine fracture
- Current pregnancy
- BMI over 40
- Inability to sense UPRIGHT vibration
- Active Systemic inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus)
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- Medical conditions causing significant functional disability (e.g. stroke, spinal cord injury, amputation)
- Severe Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)
- Severe clinical depression, or psychotic features
- Implanted electrical medical device (i.e. cardiac pacemaker/defibrillator, spinal cord stimulator, bladder stimulator)
- Allergic skin reaction to tapes or adhesives
- Worker's compensation claim or legal action related to the thoracic or lumbar pain
- Patients unable to read English and complete the assessment instruments
- Patients unable to attend assigned physical therapy sessions
- Incarcerated patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device
Read the detailed description
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device.
Physical therapy will be completed 1-2 times per week over 4-6 weeks. If randomized to the group that also receives a postural training device, one of the physical therapy sessions will instruct the patient on use of the device, which can be used thereafter as tolerated by the patient.
At 6 weeks and 3 months, questionnaires that assess patients pain and function will be completed to assess outcomes
- Conditions
- Back Pain Without Radiation, Back Pain, Low
- Being tested
- UPRIGHT, physical therapy
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPRIGHTDevice
A small externally wearable device that is placed on the back, which gently vibrates when correct posture is not maintained. The device is removable, and used for only portions of the day
physical therapyOther
routine physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Active comparator | Receive standard physical therapy Receives: Other: physical therapy |
| posture training device | Experimental | Receive a posture training device in addition to standard physical therapy Receives: Device: UPRIGHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement/Change in Pain
0-10 pain scale
Measured: Primary outcome is at 6 weeks, secondary time point 12 weeks
Secondary outcomes (1)
Improvement/Change Disability
Modified Oswestry Disability Index
Measured: 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 May 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Why it stopped: COVID 19 which is preventing outpatient and elective procedures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Without RadiationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 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
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Schneider, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449160
- Sponsor's protocol ID
- BSCHNEIDERXX
- Status last verified
- Oct 2020
- First submitted
- 4 Jan 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03449160
- Acronym / sponsor ID
- BSCHNEIDERXX
- Conditions
- Back Pain Without Radiation, Back Pain, Low
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19 which is preventing outpatient and elective procedures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device
Detailed description
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device.
Physical therapy will be completed 1-2 times per week over 4-6 weeks. If randomized to the group that also receives a postural training device, one of the physical therapy sessions will instruct the patient on use of the device, which can be used thereafter as tolerated by the patient.
At 6 weeks and 3 months, questionnaires that assess patients pain and function will be completed to assess outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Active comparator | Other: physical therapyReceive standard physical therapy |
| posture training device | Experimental | Device: UPRIGHTReceive a posture training device in addition to standard physical therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 - 65, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, and capable of attending all planned therapy sessions
- Primary complaint of lumbar or thoracic pain thought to be at least in part due to mechanical/postural etiologies based on clinical presentation
- 7 day average numeric pain rating score (NPRS) of at least 4 on a 0-10 scale at baseline evaluation
- Pain duration of at least 2 months
- Patient owns and is familiar with the use of a personal smart phone
Key exclusion criteria (15 listed)
- *History of prior thoracic or lumbar fusion surgery
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 |
|---|---|---|
| UPRIGHTA small externally wearable device that is placed on the back, which gently vibrates when correct posture is not maintained. The device is removable, and used for only portions of the day | Device | posture training device |
| physical therapyroutine physical therapy | Other | Physical Therapy |
Primary outcome
Improvement/Change in Pain
Time frame: Primary outcome is at 6 weeks, secondary time point 12 weeks
0-10 pain scale
1 secondary outcome
Improvement/Change Disability
Time frame: 6 weeks, 12 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 19 Oct 2020.
- Individual participant dataSharing planned: No
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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 UPRIGHT and physical therapy in people with Back Pain Without Radiation and Back Pain, Low, run by Vanderbilt University Medical Center 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 15 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 19 Oct 2020. 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?
Improvement/Change in Pain (time frame: Primary outcome is at 6 weeks, secondary time point 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2020.