Last updated: August 14, 2023
Sponsor: Balgrist University Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Chronic Pain
Treatment
Spinal Manipulative Therapy
Clinical Study ID
NCT03880500
BalgristUH
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria: Patients:
- Persons over 18 years and under 75 years of age with low back pain of any durationclinically not attributable to "red flags" (infection, trauma, fractures, inflammatoryillnesses).
- Source of LBP clinically at the L4/5 or L5/S1 segment.
- Duration of LBP is longer than 4 weeks
- Obtained informed consent. Controls:
- Persons over 18 years and under 75 years of age who have not suffered from low backpain in the last year and have never experienced low back pain for longer than 7consecutive days.
- Obtained informed consent.
Exclusion
Exclusion criteria: Subjects are excluded from enrolment if they
- have undergone prior spinal surgery
- have undergone facet joint, epidural or periradicular injections in the last 6 months
- had a spinal manipulative therapy intervention in the past 2 weeks
- have spinal abnormalities (benign or malignant tumors, congenital abnormalities,isthmic spondylolisthesis)
- have any contraindication to spinal manipulative interventions or are deemed unable totolerate 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)
- have any contraindication to MRI (e.g. heart pacemaker, metallic foreign body orclaustrophobia)
- have started a new prescription medication targeting blood circulation within the last 3 months
- are pregnant or nursing
- Subjects are excluded from venipuncture if they are known to be HIV-positive or haveHepatitis A, B, or C or have another systemic infection (excludes subjects fromvenipuncture). No study specific testing for HIV or Hepatitis A, B or C is performed.
Study Design
Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Spinal Manipulative Therapy
Phase:
Study Start date:
March 06, 2019
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
University Hospital Balgrist
Zürich, Zurich 8008
SwitzerlandActive - Recruiting
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