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

Intradermal Mesotherapy Versus Systemic Therapy in Treating Neck Pain to Cervical Disc Herniation: A Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04519333
Enrollment
100
Registered
2020-08-19
Start date
2019-01-01
Completion date
2020-05-01
Last updated
2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies

Keywords

Mesotherapy, Neck Pain

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.

Interventions

PROCEDUREdrug(intradermal injection)

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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.).

Design outcomes

Primary

MeasureTime frameDescription
Change in pain intensity0-24 hourswe 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.
Adverse effect0-1 weekwe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026