The effectiveness of dry needling versus low-level laser therapy in the treatment of myofascial trigger points of the upper trapezius muscles of patients referring to physical medicine clinics
Determining and comparing the therapeutic effects of dry needling and low-power laser in the treatment of trigger points in the upper trapezius muscle in clients of physical medicine clinics
Design
The following clinical trials were performed in three groups, including two intervention groups and one control group.There are 26 patients in each group.
For patients, group A dry needling was performed
For group B patients, low-power laser was performed
Settings and conduct
The present project is a standardized clinical trial study with parallel design (parallel controls) that was performed on 78 patients with myofascial upper trapezius muscle pain syndrome referred to the Physical Medicine Clinics of Isfahan University of Medical Sciences and annually. 1398 was implemented and followed up.
Participants/Inclusion and exclusion criteria
78 patients with neck and back pain entered the study by diagnosing the points of trigger of muscle fascia in the superior trapezius muscle who had referred to physical medicine clinics.
Intervention groups
All patients undergoing upper trapezius muscle stretching exercises will be placed 3 times a day (morning, evening and night) for 30 seconds each time for two weeks.Group C will only receive the same treatment Group A Acupuncture Group B low power laser therapy
Main outcome variables
1.the Visual Analogue Scale (VAS): This is the 10 cm calibrated scale, with numbers ranging from zero (no pain) to 10 (the most severe possible pain). The criterion for scoring on this scale is the number on which the patient draws a line.
2.Neck Disability Index (NDI) Questionnaire Indexcontains 10 questions. There are 7 questions related to daily affairs, 2 questions related to pain and one question about concentration,
3.Shoulder Pain and Disability Index (SPDI) : There are two dimensions, one for pain and the other for functional activities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200507047328N1
Registration date:2020-05-16, 1399/02/27
Registration timing:retrospective
Last update:2020-05-16, 1399/02/27
Update count:0
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
mohammadreza ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3433 5337
Email address
mransari.pmr@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2019-04-02, 1398/01/13
Actual recruitment end date
2020-03-16, 1398/12/26
Trial completion date
2020-03-18, 1398/12/28
Scientific title
The effectiveness of dry needling versus low-level laser therapy in the treatment of myofascial trigger points of the upper trapezius muscles of patients referring to physical medicine clinics
Public title
effect of dry needling versus low-level laser therapy in the treatment of myofascial trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with diagnosis of myofascial trigger point syndrom of upper trapezius muscle with base of Travel and Simons criteria
age 18 or over
VAS>5
Pain time over one month
Patients tend to participate in the study
Exclusion criteria:
history of Fx in cervical vertebrae
history of surgical operation in neck, known cervical myelopathy or radiculopathy
history of psychologic or cognitive disorders
opioid abuse and use of corticosteroid oral or IV
active pregnancy
coagulopathy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention and the lack of use of blinding platforms at the level of physician and patient, it cannot be performed.
Only a person who performs statistical analysis can be kept blind from assigning groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan university of medical siences
Street address
ethics committee of isfahan university of medical sciences ,No 4 building, hezar jarib ave, isfahan city
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.MUI.MED.REC.1398.564
Health conditions studied
1
Description of health condition studied
myofascial trigger points syndrome
ICD-10 code
M79.62
ICD-10 code description
Pain in upper arm
Primary outcomes
1
Description
Myofascial trigger point syndrome in the upper trapezius muscle with a VAS score above 5
Timepoint
Patients were evaluated in three periods before and immediately after the intervention and one month after the intervention
Method of measurement
Visual Analogue Scale, Index Neck Disability Index , and Shoulder Pain and Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: acupuncture. For them, 4 dry needling sessions were performed on the trigger points two days apart. In trapezius muscle treated with dry needling, we mark the points of the muscle that have the most pain as trigger points. For dry needling, special thin needles with a length of 25 mm and a thickness of 0.25 were used.
Category
Treatment - Other
2
Description
Intervention group: low-power laser therapy. For them 3 sessions for two weeks, three days each time from the novin device, type LASER 860x, class I type BF 6 joules per square centimeter, average power of 100 MW for each point for 3 minutes done
Category
Treatment - Devices
3
Description
Control group: stretching exercises .Control group: Stretching exercises. All patients - including this group - underwent upper trapezius muscle stretching exercises 3 times a day (morning, evening and night), each time for 30 seconds and for two weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Hamid Melali
Street address
Eb-e-sina St, Amin hospital, isfahan city
City
isfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۱۴۱
Phone
+98 31 3303 3400
Email
amin@mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Majid Rezvani
Street address
Al-zahra hospital ,Soffeh Ave, isfahan City
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoy e javanmard
Street address
No. 6, 32nd Alley, Negarestan St, Kaveh Blvd, Isfahan City
City
isfahan
Province
Isfehan
Postal code
8196796457
Phone
+98 31 3433 5337
Email
info@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?