Effectiveness of Chiropractic Application for Acute Low Back Pain

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110119
• Other study ID #: IMUEC441
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2021
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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.

Locations

Country	Name	City	State
Turkey	Medipol University	Beykoz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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