Spinal Manipulative Therapy for Low Back Pain

Low Back Pain Clinical Trial

Official title:

Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294229
• Other study ID #: KEK220_02
• Secondary ID: INSEL749
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2006
• Last updated: September 30, 2011
• Start date: March 2003
• Est. completion date: October 2006

Study information

• Verified date: September 2011
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• manipulative therapy

Locations

Country	Name	City	State
Switzerland	Department of Social and Preventive Medicine (ISPM), University of Bern	Bern

Sponsors (4)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Back pain overall measured by a numeric rating scale(range 0 to 10)
Primary	Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)
Secondary	Roland Morris Score
Secondary	Serious adverse events