search
Back to results

Spinal Manipulative Therapy for Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
manipulative therapy
Sponsored by
University of Bern
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Spinal manipulative therapy, Randomised controlled trial

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Age between 20 and 55 years Duration of acute low back pain less than 4 weeks Informed consent Exclusion criteria: Pregnancy Radicular origin of back pain (with irradiation) Cauda equine syndrome Neurologic deficit Epidural glucocorticoid injections in the preceding three months Previous low back surgery Severe osteoporosis Blood-coagulation disorder Allergy to planned rescue medications Suspicion of a specific cause of low back pain (fracture, tumor, infection, inflammatory disease of the spine, HIV-infection) in the patient's history or by physical examination History or signs of severe dysfunction of the liver or kidney

Sites / Locations

  • Department of Social and Preventive Medicine (ISPM), University of Bern

Outcomes

Primary Outcome Measures

Back pain overall measured by a numeric rating scale(range 0 to 10)
Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)

Secondary Outcome Measures

Roland Morris Score
Serious adverse events

Full Information

First Posted
February 16, 2006
Last Updated
September 30, 2011
Sponsor
University of Bern
Collaborators
Swiss Society for Manual Therapy (SAMM), Insel Gruppe AG, University Hospital Bern, Wissenschaftlicher Fonds WFR
search

1. Study Identification

Unique Protocol Identification Number
NCT00294229
Brief Title
Spinal Manipulative Therapy for Low Back Pain
Official Title
Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bern
Collaborators
Swiss Society for Manual Therapy (SAMM), Insel Gruppe AG, University Hospital Bern, Wissenschaftlicher Fonds WFR

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work. Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.
Detailed Description
Design: Randomised controlled parallel-group trial comparing standard care plus spinal manipulative therapy with standard care alone. Intention-to-treat analysis. Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern University Hospital and a primary care practice network.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Spinal manipulative therapy, Randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
manipulative therapy
Primary Outcome Measure Information:
Title
Back pain overall measured by a numeric rating scale(range 0 to 10)
Title
Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)
Secondary Outcome Measure Information:
Title
Roland Morris Score
Title
Serious adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age between 20 and 55 years Duration of acute low back pain less than 4 weeks Informed consent Exclusion criteria: Pregnancy Radicular origin of back pain (with irradiation) Cauda equine syndrome Neurologic deficit Epidural glucocorticoid injections in the preceding three months Previous low back surgery Severe osteoporosis Blood-coagulation disorder Allergy to planned rescue medications Suspicion of a specific cause of low back pain (fracture, tumor, infection, inflammatory disease of the spine, HIV-infection) in the patient's history or by physical examination History or signs of severe dysfunction of the liver or kidney
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M. Villiger, MD
Organizational Affiliation
Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Juni, MD
Organizational Affiliation
Department of Social and Preventive Medicine (ISPM), University of Berne
Official's Role
Study Director
Facility Information:
Facility Name
Department of Social and Preventive Medicine (ISPM), University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Spinal Manipulative Therapy for Low Back Pain

We'll reach out to this number within 24 hrs