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

Sponsor

Balgrist University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04305509

Collaborator

(none)

Enrollment

Location

15.7

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation	Other: no intervention

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 Design

Study Type:

Observational

Actual Enrollment :

98 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 9, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

LDH patients

Patients with lumbar disc herniation which was treated with manual therapy

Other: no intervention

no intervention

Outcome Measures

Primary Outcome Measures

intensity of low back pain [1 month]
intensity of low back pain in the last month (numeric rating scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chiropraktik am Schaffhauserplatz	Zurich		Switzerland	8006

Sponsors and Collaborators

Balgrist University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brigitte Wirth, Senior scientist Chiropractic Medicine, Balgrist University Hospital

ClinicalTrials.gov Identifier:

NCT04305509

Other Study ID Numbers:

PB_2019_00151

First Posted:

Mar 12, 2020

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Brigitte Wirth, Senior scientist Chiropractic Medicine, Balgrist University Hospital

long-term outcome

Additional relevant MeSH terms:

Intervertebral Disc Displacement

Radiculopathy

Hernia

Study Results

No Results Posted as of Jul 22, 2021