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

July 21, 2021 updated by: Brigitte Wirth, Balgrist University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8006
        • Chiropraktik am Schaffhauserplatz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The same patients who were recruited for the study EK-22/2009: Patients with lumbar disc herniation that is treated with spinal manipulation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LDH patients
Patients with lumbar disc herniation which was treated with manual therapy
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Principal Investigator: Lukas Mayr, M Chiro Med, Universitätsklinik Balgrist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB_2019_00151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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