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Effectiveness of Chiropractic Application for Acute Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110119
Recruitment Status : Active, not recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
ALI TIMUCIN ATAYOGLU, Medipol University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM) Other: Chiropractic Treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control: Drug-Only Group
Patients with acute lower-back pain who have undergone routine conventional drug treatment at the first visit to the emergency department (75 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)
Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages

Experimental: Case: Drug and Chiropractic Group
Patients, who received chiropractic treatment immediately after the conventional drug treatment as in the control group (75 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)
Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages

Other: Chiropractic Treatment
High speed and low amplitude spinal manipulation techniques are applied to the case group.




Primary Outcome Measures :
  1. Change in pain level [ Time Frame: Up to 5 minutes ]
    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.

  2. Change in pain level [ Time Frame: Up to 30 minutes ]
    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.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110119


Locations
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Turkey
Medipol University
Beykoz, Istanbul, Turkey, 34810
Sponsors and Collaborators
Medipol University
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Responsible Party: ALI TIMUCIN ATAYOGLU, Assistant Prof., Medipol University
ClinicalTrials.gov Identifier: NCT04110119    
Other Study ID Numbers: IMUEC441
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ALI TIMUCIN ATAYOGLU, Medipol University:
Mechanical Low Back Pain
Chiropractics
Analgesic-anti-inflammatory
myorelaxant
Thiocolchicoside
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action