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

NCT ID: NCT04305509

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-09

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lumbar Disc Herniation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LDH patients

Patients with lumbar disc herniation which was treated with manual therapy

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balgrist University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brigitte Wirth

Senior scientist Chiropractic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukas Mayr, M Chiro Med

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Balgrist

Locations

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Chiropraktik am Schaffhauserplatz

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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PB_2019_00151

Identifier Type: -

Identifier Source: org_study_id

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