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The Role of Disc Nutrition in the Etiology and Clinical Treatment of Disc Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134910
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Back Pain Intervertebral Disc Degeneration Procedure: Physical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Disc Nutrition in the Etiology and Clinical Treatment of Disc Degeneration
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 3, 2025
Estimated Study Completion Date : February 3, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical therapy
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.
Procedure: Physical Therapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Documented history of prior spinal surgery
  • Contraindications to MRI including:

    • claustrophobia
    • pregnancy
    • implanted electronic devices

      • pacemakers, cochlear implant, insulin pumps, etc
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134910


Contacts
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Contact: Sarah E Gullbrand, PhD (215) 823-5800 sgullb@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
Contact: Sarah E Gullbrand, PhD    215-823-5800    sgullb@pennmedicine.upenn.edu   
Principal Investigator: Sarah E. Gullbrand, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sarah E. Gullbrand, PhD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04134910    
Other Study ID Numbers: B3118-W
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
spine
intervertebral disc
physical therapy
imaging
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases