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Efficacy of mesotherapy using drugs versus transcutaneous electrical nerve stimulation (tens) lumbosacral chronic radiculopathy due to disk herniation

Protocol summary

Study aim
Determining and comparing the therapeutic effect of mesotherapy and TENS in improving pain and function in patients with chronic radicular back pain.
Design
A parallel randomized clinical trial study in 1402-1403 on 60 patients diagnosed with chronic radiculopathy due to disc, who were randomly assigned to one of the two intervention groups.
Settings and conduct
In this one-sided blind study, patients with chronic lumbar radiculopathy referred to physical medicine clinics of Isfahan University of Medical Sciences in 1402-1403 were randomly treated with mesotherapy and TENS, and after the completion of sampling and flow-up analysis of the data by the individual It is done without the knowledge of the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic radicular back pain due to disc herniation, age over 18 years, moderate and severe pain exclusion criteria: surgery or mesotherapy in the last 3 months, severe rheumatological and systemic or neurological diseases, inflammation in the sacroiliac joint, fracture in spine, spondylolysis or spondylolisthesis, Coagulation disorder, cancer, metabolic bone diseases, anatomical abnormalities of the spine, allergy to the drugs used, kidney failure, skin disease at the injection site. Use of complementary treatments 1 month before treatment or during treatment, drug addiction
Intervention groups
first intervention group: 6 sessions of subcutaneous mesotherapy injection of acupuncture points for back pain with the combination of 1 ml of piroxicam. 1ml of 2% lidocaine , second intervention group, transcutaneous electrical nerve stimulation (TENS)used for 10 sessions with one day intervals of 100 Hz electric current with 4 electrodes on 8 x 4 rubber for 20 minutes, all patients 10 mg Baclofen and Williams exercises 3 times a day and 5 sets each time.
Main outcome variables
pain ,function

General information

Reason for update
Acronym
transcutaneous electrical nerve stimulation (tens)
IRCT registration information
IRCT registration number: IRCT20231203060255N1
Registration date: 2024-04-09, 1403/01/21
Registration timing: registered_while_recruiting

Last update: 2024-04-09, 1403/01/21
Update count: 0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Fateme Hoseinzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 0973
Email address
fatemehoseinzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-15, 1402/07/23
Expected recruitment end date
2024-05-12, 1403/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of mesotherapy using drugs versus transcutaneous electrical nerve stimulation (tens) lumbosacral chronic radiculopathy due to disk herniation
Public title
efficacy of mesotherapy in the treatment of chronic radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Consent to participate in the study2- Patients with chronic radicular back pain due to a herniated disc (radicular pain for more than three months and confirming the diagnosis of a herniated disc as the cause of the symptoms by MRI and matching the patient's radicular symptoms with a herniated disc observed in the MRI according to the diagnosis of a physical medicine specialist3- Age above 18 years4- moderate and severe pain intensity (above 5 based on VAS)
Exclusion criteria:
1- Surgery in the last 3 months2- Rheumatological diseases or severe systemic diseases (diabetes,...)3-Neurological diseases (MS, neuropathy,...)4- History of mesotherapy in the last 3 months5- The presence of inflammation in the sacroiliac joint during examinations6- history of fracture in the spine7 presence of spondylolysis or spondylolisthesis8- Coagulation disorders (genetic disorders such as hemophilia or acquired disorders such as warfarin use)9- History of any type of cancer 10- Bone metabolic diseases such as Paget11- Anatomical abnormalities of the spine such as scoliosis12- History of any allergy to the drugs used (allergy to lidocaine or NSAID)13-Kidney failure14- Skin disease at the injection site15- Use of complementary treatments including acupuncture and herbal medicines 1 month before treatment or during treatment16-Drug addiction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
How to select the sample: random sampling is done by consecutive non-probability sampling, and the number of samples is based on the calculation formula and the number of 30 people in each group, a total of 60 people (n=30). and random allocation ,the samples included in the study are allocated to 2 groups using SPSS software. In this way, 30 random numbers from 1 to 60 are created by Excel software, which are assigned to the first intervention group, and then the remaining 30 numbers are assigned to the second group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.MUI.MED.REC.1402.263

Health conditions studied

1

Description of health condition studied
chronic radiculopathy
ICD-10 code
M54.17
ICD-10 code description
Radiculopathy, lumbosacral region

Primary outcomes

1

Description
pain
Timepoint
Immediately after treatment, one month after treatment, two months after treatment
Method of measurement
Visual Analogue Scale

2

Description
Patient function
Timepoint
Immediately after treatment, one month after treatment, two months after treatment
Method of measurement
RMQ (Roland Morris Disability Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:2 sessions per week for 3 weeks of mesotherapy for a total of 6 sessions of subcutaneous mesotherapy in acupuncture points related to back pain with 1 ml of piroxicam and 2 ml of 2% lidocaine along with exercise and muscle relaxant.
Category
Treatment - Other

2

Description
Intervention group: Intervention group: Transcutaneous electrical nerve stimulation (TENS) treatment is used with a protocol of 10 sessions with one-day intervals, in which 100 Hz electric current with 4 8x4 rubber electrodes is used for 20 minutes in each session
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Parisa Taheri
Street address
Shahada Square - Ibn Sina St. - Sanbulistan St. - Amin Medical Education Cente
City
isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Email
Prs_taheri@yahoo.com
Web page address
https://amin.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building No. 4,Hazar Jarib Street,Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
parisa taheri
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Prs_taheri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
fateme hoseinzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
fatemehoseinzade98@gamil.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
fateme hoseinzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
91746734461
Phone
+98 31 3668 0048
Email
fatemehoseinzade98@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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