Spinal Segment MRI Perfusion and Diffusion Response to Spinal Manipulation in Low Back Pain Patients

Launched by BALGRIST UNIVERSITY HOSPITAL · Mar 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how spinal manipulation, a type of hands-on therapy to help relieve back pain, affects certain changes in the spine and surrounding muscles. Researchers are using advanced MRI technology to see how blood flow and movement of water in these areas change after treatment. They want to understand if these changes can predict how well patients respond to treatment and if they relate to improvements in pain and disability.

To participate in this study, you need to be between 18 and 75 years old and have low back pain that has lasted for more than four weeks. You must not have serious medical conditions or previous spinal surgeries that could affect your participation. If you qualify, you’ll undergo MRI scans and possibly receive spinal manipulation or a control treatment. This trial aims to gather important information that could help improve care for people with low back pain in the future.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• Patients:
• • 1. Persons over 18 years and under 75 years of age with low back pain of any duration clinically not attributable to "red flags" (infection, trauma, fractures, inflammatory illnesses).
• • 2. Source of LBP clinically at the L4/5 or L5/S1 segment.
• • 3. Duration of LBP is longer than 4 weeks
• • 4. Obtained informed consent.
• Controls:
• • 1. Persons over 18 years and under 75 years of age who have not suffered from low back pain in the last year and have never experienced low back pain for longer than 7 consecutive days.
• • 2. Obtained informed consent.
• Exclusion criteria:
• • Subjects are excluded from enrolment if they
• • 1. have undergone prior spinal surgery
• • 2. have undergone facet joint, epidural or periradicular injections in the last 6 months
• • 3. had a spinal manipulative therapy intervention in the past 2 weeks
• • 4. have spinal abnormalities (benign or malignant tumors, congenital abnormalities, isthmic spondylolisthesis)
• • 5. have any contraindication to spinal manipulative interventions or are deemed unable to tolerate SMT to both body sides (e.g. pain attributable to above mentioned red flags, inability to perform side-lying without pain, radiculopathy with motor deficits \<M4-, severe spinal canal stenosis)
• • 6. have any contraindication to MRI (e.g. heart pacemaker, metallic foreign body or claustrophobia)
• • 7. have started a new prescription medication targeting blood circulation within the last 3 months
• • 8. are pregnant or nursing
• • 9. Subjects are excluded from venipuncture if they are known to be HIV-positive or have Hepatitis A, B, or C or have another systemic infection (excludes subjects from venipuncture). No study specific testing for HIV or Hepatitis A, B or C is performed.