Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc
Primary Purpose
Emergencies
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
drug(intradermal injection)
Sponsored by
About this trial
This is an interventional treatment trial for Emergencies focused on measuring Mesotherapy, Neck Pain
Eligibility Criteria
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.).
Sites / Locations
- Ataturk University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Compare to sistemic treatment and mesotherapy.
Arm Description
This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04519333
Brief Title
Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc
Official Title
Intradermal Mesotherapy Versus Systemic Therapy in Treating Neck Pain to Cervical Disc Herniation: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
Mesotherapy, Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compare to sistemic treatment and mesotherapy.
Arm Type
Other
Arm Description
This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation
Intervention Type
Procedure
Intervention Name(s)
drug(intradermal injection)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
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.
Time Frame
0-24 hours
Title
Adverse effect
Description
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.
Time Frame
0-1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc
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