NCT04110119

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

September 21, 2019

Last Update Submit

April 20, 2021

Conditions

Low Back Pain, Mechanical

Keywords

Mechanical Low Back PainChiropracticsAnalgesic-anti-inflammatorymyorelaxantThiocolchicoside

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Control: Drug-Only Group

ACTIVE COMPARATOR

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)

Case: Drug and Chiropractic Group

EXPERIMENTAL

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)Other: Chiropractic Treatment

Interventions

diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)DRUG

Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages

Case: Drug and Chiropractic GroupControl: Drug-Only Group
Chiropractic TreatmentOTHER

High speed and low amplitude spinal manipulation techniques are applied to the case group.

Case: Drug and Chiropractic Group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Beykoz, Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

thiocolchicoside

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof.

Study Record Dates

First Submitted

September 21, 2019

First Posted

October 1, 2019

Study Start

October 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations

TU(1)