Spinal Manipulative Therapy for Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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manipulative therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of Bern

Principal Investigators

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Peter M. Villiger, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne

Peter Juni, MD

Role: STUDY_DIRECTOR

Department of Social and Preventive Medicine (ISPM), University of Berne

Locations

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

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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INSEL749

Identifier Type: -

Identifier Source: secondary_id

KEK220_02