Effectiveness of Chiropractic Application for Acute Low Back Pain

NCT ID: NCT04110119

Last Updated: 2021-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain, Mechanical

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 (49 patients). The drug treatment consists of analgesic-anti-inflammatory (diclophenac sodium 75 mg IM) and myorelaxant (thiocolchicoside 4 mg IM), administered only once.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Case: Drug and Chiropractic Group

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Chiropractic Treatment

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Chiropractic Treatment

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medipol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ALI TIMUCIN ATAYOGLU

Assistant Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medipol University

Beykoz, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IMUEC441

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.