Outcomes After Chiropractic Spinal Manipulative Therapy With Lumbar Disc Herniation and Radiculopathy

Overview

In a study that was approved nine years ago (EK-22/2009) we could show (i) that spinal manipulative therapy (SMT) is a very effective and safe treatment for acute and chronic lumbar disc herniation (LDH); (ii) that SMT is as effective and less expensive than lumbar nerve root injections and (iii) that the recurrence rate up to one year was very low in acute and in chronic LDH patients. However, the long-term outcome of this conservatively treated LDH patients is unknown. Thus, the objective of this amendment is to investigate the proportion of long-term recurrences in these patients who were treated with SMT for their LDH and to compare these results with already existing data from other treatments, e.g. surgery. This is important information to know whether this conservative method is a sustainable approach for treating LDH.

Full Title of Study: “Outcomes After Chiropractic Spinal Manipulative Therapy for Patients With Lumbar Disc Herniation and Radiculopathy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2021

Detailed Description

All 148 patients with magnetic resonance imaging-confirmed disc herniation who were recruited for the study EK 22-2009 will be re-contacted to assess the course of their back problem during the past approx. nine years using a questionnaire.

Interventions

  • Other: no intervention
    • no intervention

Arms, Groups and Cohorts

  • LDH patients
    • Patients with lumbar disc herniation which was treated with manual therapy

Clinical Trial Outcome Measures

Primary Measures

  • intensity of low back pain
    • Time Frame: 1 month
    • intensity of low back pain in the last month (numeric rating scale)

Participating in This Clinical Trial

Inclusion Criteria

-The same patients who were recruited for the study EK-22/2009 Exclusion Criteria:

  • The same as for study EK-22/2009: Patients with specific pathologies of the lumbar spine that are contraindications to chiropractic manipulative treatment, such as tumors, infections, inflammatory spondylarthropathies, acute fractures, Paget's disease and severe osteoporosis, will be excluded. Also excluded will be patients with previous spinal surgery, signs of cauda equina syndrome (CES), sequestration of disc material, body mass index >30, spondylolisthesis, neurogenic claudication and pregnancy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Balgrist University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brigitte Wirth, Senior scientist Chiropractic Medicine – Balgrist University Hospital
  • Overall Official(s)
    • Lukas Mayr, M Chiro Med, Principal Investigator, Universitätsklinik Balgrist

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