Examining MRI Changes in Spinal Tissue After Manipulation for Low Back Pain

MRI-quantified Changes in Perfusion and Diffusion in Spinal Segments After High-Velocity, Low-Amplitude Spinal Manipulation: A Randomized Controlled Trial

This study is testing how spinal manipulation therapy affects the tissues in the spine of people with low back pain to see if it helps with their pain and disability.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Balgrist University Hospital (Academic / other)
• Locations: 1 site (Zürich, Zurich)
• Trial ID: NCT03880500 on ClinicalTrials.gov

What this trial studies

This study aims to measure changes in diffusion and perfusion in the intervertebral disc and surrounding spinal muscle tissue in patients with low back pain after receiving spinal manipulative therapy. Using advanced MRI techniques, the study will assess how these changes correlate with clinical outcomes such as pain and disability. Additionally, it will evaluate the repeatability of these MRI measurements and compare them with healthy controls to establish baseline data. The research seeks to better understand the underlying mechanisms of spinal manipulation and its effects on low back pain.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with low back pain lasting more than four weeks that is not attributable to serious underlying conditions.

Not a fit: Patients with a history of spinal surgery, recent spinal injections, or specific spinal abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of spinal manipulation for low back pain, potentially leading to improved treatment strategies.

How similar studies have performed: While studies on spinal manipulation exist, this approach using advanced MRI techniques to quantify tissue changes is relatively novel.

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.

Where this trial is running

Zürich, Zurich

• University Hospital Balgrist — Zürich, Zurich, Switzerland (Recruiting)

Study contacts

• Principal investigator: Petra Schweinhardt, PhD, MD — Balgrist University Hospital
• Study coordinator: Malin B Muehlemann, Dr med.chiro

Conditions Pain, Back