Spinal Manipulative Therapy for Low Back Pain

Sponsor

University of Bern (Other)

Overall Status

Completed

CT.gov ID

NCT00294229

Collaborator

Swiss Society for Manual Therapy (SAMM) (Other), University Hospital Inselspital, Berne (Other), Wissenschaftlicher Fonds WFR (Other)

104

Enrollment

Location

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: manipulative therapy	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Social and Preventive Medicine (ISPM), University of Bern	Bern		Switzerland	3012

Sponsors and Collaborators

University of Bern
Swiss Society for Manual Therapy (SAMM)
University Hospital Inselspital, Berne
Wissenschaftlicher Fonds WFR

Investigators

Principal Investigator: Peter M. Villiger, MD, Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne
Study Director: Peter Juni, MD, Department of Social and Preventive Medicine (ISPM), University of Berne