Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc

NCT04519333 | Completed

• 1 other identifier: AtaturkU0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Neck pain is a global public health concern, that ranked 4th highest health condition in terms of disability as measured by years lived with disability. The aim of this study is to compare the efficiency of one-session mesotherapy application with systemic therapy in treating neck pain related to cervical disk herniation. Methods: This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation. A mixture of thiocolchicoside, lidocaine and tenoxicamwas administered via mesotherapy in one group, and intravenous administration of dexketoprofen was applied to the other group. We compared the changes in pain intensity at 60thminute, 120thminute and 24th hours after treatment using Visual Analogue Scale (VAS),and adverse effects of the treatment methods among the study groups.

Conditions

Emergencies

Keywords

Mesotherapy; Neck Pain

Outcome Measures

Primary Outcomes (2)

• Change in pain intensity

  we defined as the delta value of Vizuel Analog Score(points between 0-10,the most severe pain 10 points,0 points no pain) scores with different time intervals. We calculated delta values by subtracting the VAS scores at 60th and 120th minutes, and 24th hours from the VAS score on admission.

  0-24 hours

• Adverse effect

  we have defined as the presence of hypotension, dizziness, nausea, vomiting, diarrhea, edema, localized infections, pruritus, bruising or swelling at the injection sites in the mesotherapy group; and presence of dry mouth, hypotension, dizziness, nausea, vomiting, diarrhea, dyspepsia, peptic ulceration, peptic ulcer bleeding, urticarial lesion, pruritus in the systemic therapy group. The patients were followed up for one week for presence of adverse effects. We interviewed with the patientsdaily by telephone for adverse effects, and evaluated all the patientswith an ED visit at the end of follow-up period.

  0-1 week

Study Arms (1)

Compare to sistemic treatment and mesotherapy.

OTHER

This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation

Procedure: drug(intradermal injection)

Interventions

drug(intradermal injection) PROCEDURE

The mesotherapy was performed by an experienced and trained physician using a disposable 4 mm and 6 mm long, 30 Gauge needles. Initially, a pharmacological mixture of 1 cc (2 mg) thiocolchicoside, 1 cc (16.2 mg) lidocaine and 1 cc (5 mg) tenoxicam was prepared for each treatment session, and 0.1-0.2 cc of this mixture was applied to each injection point with a depth of 1-3 mm using point by point intradermal method without causing papules. In the systemic therapy group, we applied a 50 mg dexketoprofen (Revafen, Haver Pharma Pharmaceutical Co., Turkey) in 100 cc isotonic solution intravenously for 5 minutes.

Compare to sistemic treatment and mesotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older age
• Admission to Emergency Department (ED) with acute cervical pain related to cervical disk herniation.

You may not qualify if:

• Taking analgesic drugs before admission
• Having VAS score of lower than 4 on admission
• Having diabetes mellitus
• Body mass index\>30 kg/m2
• Pregnancy
• Lactation
• Having active bleeding or bleeding disorder
• Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions
• Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergencies; Neck Pain

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: May 1, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)