Effectiveness of Chiropractic Application for Acute Low Back Pain

Study Overview
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Brief Summary
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The aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the Clinical Practice Guidelines

Official Title
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Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment

Conditions
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Low Back Pain, Mechanical

Intervention / Treatment
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* Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)
* Other: Chiropractic Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 19 and 65. Acute lower-back pain, persisting less than 6 weeks, meeting the diagnostic classification of 1 or 2 according to the Quebec Task Force on Spinal Disorders Exclusion Criteria: Previous spine surgery Spinal nerve root irritation or deficits, Pregnant women, Lower-back pain due to occupational accidents Obesity status (body mass index> 30). Chronic lower-back pain longer than 6 weeks.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: Drug-Only Group<br>Patients with acute lower-back pain who have undergone routine conventional drug treatment at the first visit to the emergency department (49 patients). The drug treatment consists of analgesic-anti-inflammatory (diclophenac sodium 75 mg IM) and myorelaxant (thiocolchicoside 4 mg IM), administered only once. | Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)<br>* Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages<br>|
| Experimental: Case: Drug and Chiropractic Group<br>Patients, who received chiropractic treatment immediately after the conventional drug treatment as in the control group (49 patients). The chiropractic treatment consists of high speed and low amplitude spinal manipulation techniques, applied only once. | Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)<br>* Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages<br>Other: Chiropractic Treatment<br>* High speed and low amplitude spinal manipulation techniques are applied to the case group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level | Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain. | Up to 5 minutes | 
| Change in pain level | Visual Analogue Pain Scale (VAS) assessment at the fifth minute after the injection of drug. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It uses a ten centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain. | Up to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Low Back Pain, Chiropractics, Analgesic-anti-inflammatory, myorelaxant, Thiocolchicoside