The purpose of this study is to compare the effect of hyaluronidase and lidocaine injection on myofascial pain syndrome.
Design
After obtaining the criteria for entering the study, 26 eligible patients were randomly assigned into three groups of hyaluronidase and lidocaine. After providing explanations for the protocol, pain measurements are based on the VAS scale and neck flexure using a goniometer. The injection method is as follows: 3.2 ml of hyaluronidase (containing 1% hyaluronidase and 0.9% normal saline) and 3.2 ml lidocaine (containing% 1 lidocaine and 0.9% normal saline ) Are injected. Injection is performed on two painful points of trapezius muscle with ultrasound guidance for each patient, and pressure is applied to prevent the bleeding of the injection site for two minutes. It is also used to inject a needle from 25 goggles. The VAS, ROM level is measured before injection, week 1, week 4, week 6 and 12 weeks.
Settings and conduct
Taleghani hospital
Participants/Inclusion and exclusion criteria
nclusion criteria:
1. Being in the range of 25 to 75 years
2. Having chronic pain over the past three months
3. Having back pain in the upper area
Exit criteria:
1. Having a history of hypersensitivity to bicarbonate, lidocaine and hyaluronidase
2. Having anticoagulant medication within three days before starting the study
3. Having analgesic drugs, including non-steroidal anti-inflammatory drugs, acetaminophen with drug use five days before the start of the study
4. Having pain associated with trauma six months before the start of the study
5. Having a history of surgery in the shoulder and neck area
6. TPI in the same area three months before the start of the study
7. Having fibromyalgia
Intervention groups
Hyaluronidase injection group
And Lidocaine injection group
Main outcome variables
pain rate, Neck flexion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190304042908N1
Registration date:2019-11-01, 1398/08/10
Registration timing:registered_while_recruiting
Last update:2019-11-01, 1398/08/10
Update count:0
Registration date
2019-11-01, 1398/08/10
Registrant information
Name
mahshid ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2588
Email address
ghasemimahshid529@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Hyaluronidase and Lidocaine Injection on Myofascial Pain Syndrome
Public title
the Effect of Hyaluronidase and Lidocaine Injection on Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient placement in the range of 25 to 75 years
Having chronic pain in the last three months
Having back pain in the upper area
Exclusion criteria:
Having a history of hypersensitivity to bicarbonate, lidocaine and hyaluronidase
Having anticoagulant medication within three days before starting the study
Having analgesic drugs, including non-steroidal anti-inflammatory drugs, acetaminophen with drug use five days before the start of the study
Having pain associated with trauma six months before the start of the study
Having a history of surgery in the shoulder and neck area
TPI in the same area three months before the start of the study
Having diseases like cancer, endocrinology, depression or schizophrenia.
Having obesity (BMI less than 27)
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients included in the study were divided into 2 groups by a random-number table. The research sample was determined using sampling method based on entry criteria and considering the possibility of destruction, 24 people .People are selected with easy sampling and are enrolled in the study.Then, they are divided into two groups of control and intervention by simple random sampling law
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
tehran
Province
Tehran
Postal code
15683287
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.333
Health conditions studied
1
Description of health condition studied
Patients who experience chronic pain in the dorsal muscles.
ICD-10 code
G89.4
ICD-10 code description
Chronic pain syndrome
Primary outcomes
1
Description
Pain rate, Neck muscle flexion
Timepoint
Before injection, week one, week four, week six and week twelve
Method of measurement
Visual Analog Scale VAS Pain: This scale represents the pain of patients in general. This scale is plotted as a 10-cm line, and the pain range is between 0 and 10 cm. The zero number does not show any pain, the number 1 to 3 mild pain, the number 4 to 6 average pain and the number 7 to 10 severe pain. The internal stability of this tool is 0.85. Up to 95 /. ROM: The neck flexion rate is measured using a goniometer. In this way, the goniometer axis is placed in the neck of the neck of the neck and on the proximal shoulder. The fixed arm is held along the horizons and movable arm along the longitudinal line of the neck, and the neck flexion range is asked from the person to move the neck forward without moving the head, and the angular changes are recorded.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hyaluronidase injection group. Hyaluronidase 3.2 ml (containing 1% hyaluronidase and 0.9% normal saline) are injected. Injection is performed on two painful points of trapezius muscle with ultrasound guidance for each patient and pressure is applied to prevent the bleeding of the injection site for two minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: Lidocaine injection group. The lidocaine group is injected with 2.3 ml (containing 1% lidocaine and 0.9% normal saline). The injection is performed on two painful points of the trapezius muscle with ultrasound guidance for each patient and is pressed for two minutes to prevent bleeding at the injection site.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Mahshid Ghasemi
Street address
No.20 , Velenjak St
City
Tehran
Province
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Email
Ghasemimahshid529@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaee
Street address
velenjak st
City
tehran
Province
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Email
mahshidghasemi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahshid Ghasemi
Position
assistant profesore
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
velenjak st
City
tehran
Province
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Email
mahshidghasemi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Mahshid Ghasemi
Position
assistance professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
20 velenjak st
City
tehran
Province
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Email
mahshidghasemi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshid Ghasemi
Position
Assistance professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
20 velenjak
City
tehran
Province
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Email
mahshidghasemi@sbmu.ac.ir
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
No - There is not 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