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

NCT04305509 | Completed

• 1 other identifier: PB_2019_00151
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

long-term outcome

Outcome Measures

Primary Outcomes (1)

• intensity of low back pain

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

  1 month

Study Arms (1)

LDH patients

Patients with lumbar disc herniation which was treated with manual therapy

Other: no intervention

Interventions

no intervention OTHER

no intervention

LDH patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• The same patients who were recruited for the study EK-22/2009

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Chiropraktik am Schaffhauserplatz

Zurich, 8006, Switzerland

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lukas Mayr, M Chiro Med

  Universitätsklinik Balgrist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior scientist Chiropractic Medicine

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: March 9, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)