Effectiveness of Chiropractic Application for Acute Low Back Pain

Phase 2

Completed

• Conditions: Low Back Pain, Mechanical
• Interventions: Drug: diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM); Other: Chiropractic Treatment

• Registration Number: NCT04110119
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-09-21
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-10-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case: Drug and Chiropractic Group	diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)	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.
Control: Drug-Only Group	diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)	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.
Case: Drug and Chiropractic Group	Chiropractic Treatment	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.

Primary Outcome Measures

Name	Time	Method
Change in pain level	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.

Trial Locations

Locations (1)

Medipol University; 🇹🇷 Beykoz, Istanbul, Turkey