Back PainNCT04134910
The Role of Disc Nutrition in the Etiology and Clinical Treatment of Disc Degeneration
A study testing Physical Therapy in people with Back Pain and Intervertebral Disc Degeneration, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effects of physical therapy on the spinal discs. Back pain is the number one cause of disability in the US, and the spine is the most common location of chronic pain in Veterans. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Intervertebral Disc Degeneration
- What is being tested?
- Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 3 Feb 2025
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current activity limiting low back pain
- With symptoms of any duration
- With or without symptoms extending distal to the buttocks
- Medically stable
- Candidate for physical therapy
Who cannot join
- Documented history of prior spinal surgery
- Contraindications to MRI including:
- claustrophobia
- pregnancy
- implanted electronic devices
- pacemakers, cochlear implant, insulin pumps, etc
Show all 14Show fewer
- metallic foreign bodies
- i.e. shrapnel
- documented history of contraindications to gadodiamide (Omniscan) administration:
- chronic severe kidney disease
- acute kidney injury
- impaired elimination of gadolinium based contrast agents
- pre-existing renal insufficiency
- a prior hypersensitivity reaction to MRI contrast
Trial locations and contacts
1 site in 1 country.
United States1 site
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
About this study
The purpose of this research study is to examine the effects of physical therapy on the spinal discs. Back pain is the number one cause of disability in the US, and the spine is the most common location of chronic pain in Veterans. Physical therapy is often very effective at improving patients' back pain, but it does not work for everyone, and it is not understood how physical therapy alters the tissues within the spine. With this research the investigators hope to learn if the investigative team can measure changes to the spinal discs on MRI scans that might predict if a patient's back pain will improve with physical therapy or not.
Read the detailed description
Low back pain, which is frequently associated with intervertebral disc degeneration, is the most common cause of adult disability in the United States. Among active service members, the incidence of disc degeneration more than doubled from 2001 to 2010, with over 68,000 days of lost duty time attributed to disc degeneration.2 The most common location of chronic pain in Veterans is the spine. The incidence of back pain in the general public has remained relatively stable over the past decade, however, there has been more than a 50% increase in the number of Veterans diagnosed with back pain. The intervertebral discs are the largest avascular structures in the body, and therefore cells within the disc rely on transport from the small vessels in the adjacent vertebral endplate to receive nutrients and expel waste products. Despite the immense social and economic burden of back pain, the etiology of disc degeneration remains poorly understood. Because of the avascular nature of the disc, it has been speculated that poor disc nutrition characterized by reduced trans-endplate transport into the disc could contribute to the initiation and progression of degeneration. If a reduction in trans-endplate transport of nutrients and waste products is a primary contributor to the initiation and progression of the degenerative cascade, then enhancing disc nutrition may have a therapeutic effect. Physical therapy and exercise can be very effective in managing back pain for certain patients, yet it is not fully understood why certain patients respond to physical therapy and others do not, and what effects such interventions have on disc nutrition and disc health. The goal of this study is to undertake a pilot study to determine the feasibility and preliminary outcomes of utilizing quantitative MRI in human patients to quantify changes in disc health and trans-endplate transport over the course of physical therapy.
To do so, patients with low back pain and concomitant disc degeneration, who have not had prior spinal surgery, will be recruited. Recruited patients will undergo MRI T2-mapping and post-contrast enhanced T1-mapping of their lumbar spines at 1.5T to measure disc health and nutrition, respectively. Patients will then begin a 6 week physical therapy treatment regimen, after which the same MRI scans will be performed again on each patient. Pain and disability level of patients will be assessed via the visual analog scale (VAS) and Oswestry Disability Index (ODI) questionnaires, both pre- and post-treatment. Lumbar active range of motion will also be quantified at the initial and final in-office physical therapy session. Inclinometers will be placed at the thoracolumbar junction and sacrum, and the patient asked to bend forward and backward. Lumbar flexion will be quantified as the difference in motion between the two inclinometers.
Significant differences T1 and T2 values in the disc, as well as VAS and ODI scores and lumbar range of motion, before and after physical therapy will be assessed via a paired t-test, with significance defined as p<0.05. Univariate linear correlations between the changes in T1 or T2 values and changes in VAS, ODI scores and lumbar range of motion will be performed to determine if altered disc health or nutrition with physical therapy is significantly correlated with improvements in pain and disability.
- Conditions
- Back Pain, Intervertebral Disc Degeneration
- Being tested
- Physical Therapy
- Keywords
- spine, intervertebral disc, physical therapy, imaging
- Medical subject headings
- Back Pain, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyProcedure or surgery
Subjects will be prescribed a 6-week physical therapy regimen consisting of one 45 minute in office visit per week, and home exercises performed daily. The in-office visits with a physical therapy provider will consist of the application of manual therapy, particularly high-velocity, low amplitude thrust mobilization in the anterior/posterior direction of the lumbar spine. In office visits will also include supervised repeated motion of the lumbar spine into extension (McKenzie therapy, 3 sets of 10 repetitions, in prone and standing positions) Patients will be instructed to complete these repeated extension exercises at home daily for the 6 week period.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy | Experimental | Subjects will be prescribed a 6-week physical therapy regimen consisting of one 45 minute in office visit per week, and home exercises performed daily. The in-office visits with a physical therapy provider will consist of the application of manual therapy, particularly high-velocity, low amplitude thrust mobilization in the anterior/posterior direction of the lumbar spine. In office visits will also include supervised repeated motion of the lumbar spine into extension (McKenzie therapy, 3 sets of 10 repetitions, in prone and standing positions) Patients will be instructed to complete these repeated extension exercises at home daily for the 6 week period. Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disc T2 relaxation time
Subjects will undergo MRI scanning to obtain T2-maps of the lumbar spine before and after 6 weeks of physical therapy. T2 relaxation times of the disc tissues are calculated from the images.
Measured: 0 to 6 weeks
Change in Visual Analog Scale (VAS) score
Subjects will complete a visual analog scale (VAS) for their back pain before and after 6 weeks of physical therapy. This is a scale from 0 (no pain) to 15 (the worst imaginable pain).
Measured: 0 to 6 weeks
Change in Lumbar Range of Motion
Lumbar range of motion will be measured using inclinometers placed on the subject's upper and lower back, at both the index and final in-office physical therapy visit.
Measured: 0 to 6 weeks
Change in Disc T1 relaxation time
Subjects will undergo MRI scanning to obtain post-contrast enhanced T1 maps of the lumbar spine before and after 6 weeks of physical therapy. To obtain the T1 maps, an intravenous catheter will be placed, and 0.1 mmols/kg of Omniscan will be administered. T1 MRIs will be acquired prior to and 2 hours following Omniscan administration. T1 relaxation times of the disc tissues are calculated from the images.
Measured: 0 to 6 weeks
Change in Oswestry Disability Index (ODI) score
Subjects will complete the ODI questionnaire before and after 6 weeks of physical therapy. This is a scale from 0 (no disability) to 50 (bed bound).
Measured: 0 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start3 Feb 2025
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Why it stopped: Grant funding spent on other aims prior to beginning this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah E. Gullbrand, PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134910
- Sponsor's protocol ID
- B3118-W
- Status last verified
- Feb 2026
- First submitted
- 18 Oct 2019
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Disc Nutrition in the Etiology and Clinical Treatment of Disc Degeneration
- ClinicalTrials.gov ID
- NCT04134910
- Acronym / sponsor ID
- B3118-W
- Conditions
- Back Pain, Intervertebral Disc Degeneration
- Keywords
- spine, intervertebral disc, physical therapy, imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant funding spent on other aims prior to beginning this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 22 Oct 2019 (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.
The purpose of this research study is to examine the effects of physical therapy on the spinal discs. Back pain is the number one cause of disability in the US, and the spine is the most common location of chronic pain in Veterans. Physical therapy is often very effective at improving patients' back pain, but it does not work for everyone, and it is not understood how physical therapy alters the tissues within the spine. With this research the investigators hope to learn if the investigative team can measure changes to the spinal discs on MRI scans that might predict if a patient's back pain will improve with physical therapy or not.
Detailed description
Low back pain, which is frequently associated with intervertebral disc degeneration, is the most common cause of adult disability in the United States. Among active service members, the incidence of disc degeneration more than doubled from 2001 to 2010, with over 68,000 days of lost duty time attributed to disc degeneration.2 The most common location of chronic pain in Veterans is the spine. The incidence of back pain in the general public has remained relatively stable over the past decade, however, there has been more than a 50% increase in the number of Veterans diagnosed with back pain. The intervertebral discs are the largest avascular structures in the body, and therefore cells within the disc rely on transport from the small vessels in the adjacent vertebral endplate to receive nutrients and expel waste products. Despite the immense social and economic burden of back pain, the etiology of disc degeneration remains poorly understood. Because of the avascular nature of the disc, it has been speculated that poor disc nutrition characterized by reduced trans-endplate transport into the disc could contribute to the initiation and progression of degeneration. If a reduction in trans-endplate transport of nutrients and waste products is a primary contributor to the initiation and progression of the degenerative cascade, then enhancing disc nutrition may have a therapeutic effect. Physical therapy and exercise can be very effective in managing back pain for certain patients, yet it is not fully understood why certain patients respond to physical therapy and others do not, and what effects such interventions have on disc nutrition and disc health. The goal of this study is to undertake a pilot study to determine the feasibility and preliminary outcomes of utilizing quantitative MRI in human patients to quantify changes in disc health and trans-endplate transport over the course of physical therapy.
To do so, patients with low back pain and concomitant disc degeneration, who have not had prior spinal surgery, will be recruited. Recruited patients will undergo MRI T2-mapping and post-contrast enhanced T1-mapping of their lumbar spines at 1.5T to measure disc health and nutrition, respectively. Patients will then begin a 6 week physical therapy treatment regimen, after which the same MRI scans will be performed again on each patient. Pain and disability level of patients will be assessed via the visual analog scale (VAS) and Oswestry Disability Index (ODI) questionnaires, both pre- and post-treatment. Lumbar active range of motion will also be quantified at the initial and final in-office physical therapy session. Inclinometers will be placed at the thoracolumbar junction and sacrum, and the patient asked to bend forward and backward. Lumbar flexion will be quantified as the difference in motion between the two inclinometers.
Significant differences T1 and T2 values in the disc, as well as VAS and ODI scores and lumbar range of motion, before and after physical therapy will be assessed via a paired t-test, with significance defined as p<0.05. Univariate linear correlations between the changes in T1 or T2 values and changes in VAS, ODI scores and lumbar range of motion will be performed to determine if altered disc health or nutrition with physical therapy is significantly correlated with improvements in pain and disability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical therapy | Experimental | Procedure: Physical TherapySubjects will be prescribed a 6-week physical therapy regimen consisting of one 45 minute in office visit per week, and home exercises performed daily. The in-office visits with a physical therapy provider will consist of the application of manual therapy, particularly high-velocity, low amplitude thrust mobilization in the anterior/posterior direction of the lumbar spine. In office visits will also include supervised repeated motion of the lumbar spine into extension (McKenzie therapy, 3 sets of 10 repetitions, in prone and standing positions) Patients will be instructed to complete these repeated extension exercises at home daily for the 6 week period. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current activity limiting low back pain
- With symptoms of any duration
- With or without symptoms extending distal to the buttocks
- Medically stable
- Candidate for physical therapy
Key exclusion criteria (14 listed)
- Documented history of prior spinal surgery
- Contraindications to MRI including:
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 |
|---|---|---|
| Physical TherapySubjects will be prescribed a 6-week physical therapy regimen consisting of one 45 minute in office visit per week, and home exercises performed daily. The in-office visits with a physical therapy provider will consist of the application of manual therapy, particularly high-velocity, low amplitude thrust mobilization in the anterior/posterior direction of the lumbar spine. In office visits will also include supervised repeated motion of the lumbar spine into extension (McKenzie therapy, 3 sets of 10 repetitions, in prone and standing positions) Patients will be instructed to complete these repeated extension exercises at home daily for the 6 week period. | Procedure or surgery | Physical therapy |
Primary outcome
Change in Disc T2 relaxation time
Time frame: 0 to 6 weeks
Subjects will undergo MRI scanning to obtain T2-maps of the lumbar spine before and after 6 weeks of physical therapy. T2 relaxation times of the disc tissues are calculated from the images.
Change in Visual Analog Scale (VAS) score
Time frame: 0 to 6 weeks
Subjects will complete a visual analog scale (VAS) for their back pain before and after 6 weeks of physical therapy. This is a scale from 0 (no pain) to 15 (the worst imaginable pain).
Change in Lumbar Range of Motion
Time frame: 0 to 6 weeks
Lumbar range of motion will be measured using inclinometers placed on the subject's upper and lower back, at both the index and final in-office physical therapy visit.
Change in Disc T1 relaxation time
Time frame: 0 to 6 weeks
Subjects will undergo MRI scanning to obtain post-contrast enhanced T1 maps of the lumbar spine before and after 6 weeks of physical therapy. To obtain the T1 maps, an intravenous catheter will be placed, and 0.1 mmols/kg of Omniscan will be administered. T1 MRIs will be acquired prior to and 2 hours following Omniscan administration. T1 relaxation times of the disc tissues are calculated from the images.
Change in Oswestry Disability Index (ODI) score
Time frame: 0 to 6 weeks
Subjects will complete the ODI questionnaire before and after 6 weeks of physical therapy. This is a scale from 0 (no disability) to 50 (bed bound).
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 27 Feb 2026.
- 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.
Sarah E. Gullbrand, PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Back Pain and Intervertebral Disc Degeneration, run by VA Office of Research and Development 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 5 inclusion and 14 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 27 Feb 2026. 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?
Change in Disc T2 relaxation time (time frame: 0 to 6 weeks). The study lists 5 primary outcomes in all. 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 27 Feb 2026.