Spinal Manipulative Therapy for Low Back Pain

Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: manipulative therapy

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • Department of Social and Preventive Medicine (ISPM), University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Age between 20 and 55 years
2. Duration of acute low back pain less than 4 weeks
3. Informed consent

Exclusion criteria:

1. Pregnancy
2. Radicular origin of back pain (with irradiation)
3. Cauda equine syndrome
4. Neurologic deficit
5. Epidural glucocorticoid injections in the preceding three months
6. Previous low back surgery
7. Severe osteoporosis
8. Blood-coagulation disorder
9. Allergy to planned rescue medications
10. 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
11. History or signs of severe dysfunction of the liver or kidney

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Serious adverse events
Roland Morris Score

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital Inselspital, Berne; Swiss Society for Manual Therapy (SAMM); 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

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: February 16, 2006
• First Submitted That Met QC Criteria: February 16, 2006
• First Posted (Estimate): February 20, 2006

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 30, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Low back pain; Randomised controlled trial; Spinal manipulative therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KEK220_02; INSEL749