Effects of Single Session Intramuscular Electrical Stimulation through Dry Needling on Pain and Dysfunction Following Trigger Points in Upper Trapezius Muscle
Background and Objective:
Myofascial Pain Syndrome (MPS) is a common disorder of musculoskeletal system. About one third of people with musculoskeletal disorders have been identified as the MPS. The MPS cause by trigger points. Variety of treatment methods is applied to care the MPS and relative disorders. The purpose of this study is to investigate effects of single session Intramuscular Electrical Stimulation (IMES) using dry needling on pain and dysfunction following trigger points in upper trapezius muscle.
Methods: This study is a randomized, double-blind, placebo-controlled clinical trial. 30 volunteers with active trigger points in upper trapezius randomly will be divided into two main groups including the IMES (15 female) and placebo (15 female). In the IMES group, trigger points on the affected side identify and will
be injected through dry needling. Then, a burst current (2 Hz frequency, 200µs pulse width) apply through the needles while electrical current steadily increase to meet a pain free contraction. In placebo group, procedure is exactly similar but no electrical stimulation apply following Intramuscular Dry Needling (IDN). Pain sensation (by Visual Analog Scale=VAS), and Pain Pressure Threshold (PPT) ( by algometer), range of motion (by goniometer) and disability (by Neck Disability Index=NDI) were measured before application and exactly after treatment and followed again one week later . All outcome measures assesse by another researcher do not have details about the groups.
In this study, researcher that measure outcome measure do not know details about intervention in each groups. Patients are not informed about the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061634567N1
Registration date:2017-08-05, 1396/05/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
monavar hadizdeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 2057
Email address
hadizadeh-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Single Session Intramuscular Electrical Stimulation through Dry Needling on Pain and Dysfunction Following Trigger Points in Upper Trapezius Muscle
Public title
Effects of Intramuscular Electrical Stimulation on Upper Trapezius Trigger Points Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Active trigger points with specific bundle in upper trapezius muscle
2. The pain associated with the trigger point of the upper trapezius muscle be higher than 3 based on the VAS scale, which is considered as moderate pain.
3. Age 18-40
4. Do not give injections or other treatments for trigger points within a month before the study.
5. No history of muscle diseases such as fibromyalgia and myopathy.
6. No malignancy or patients susceptible to infection.
7. Not having central and peripheral neurological disorders.
8. Not having radical pain and history of neck surgery.
9. have no previous history of bad response to acupuncture or dry needling.
10. No pregnancy
11. Do not use anticoagulants.
12. No significant fears from the dry needling.
13. Not having vascular disease.
14. Not having diabetes.
15. Not having a history of migraine.
exclusion criteria:
1. Withdrawal of cooperation by the patient.
2. Discomfort and intolerance method applied to the patient.
3. Incidence of abnormal reactions during dry needling and treatment.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study for randomization will be used balanced block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Tehran University of Medical Sciences
Street address
Tehran, Keshavarz Blvd, Central building of Tehran University of Medical Sciences
City
tehran
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2216
Health conditions studied
1
Description of health condition studied
Trigger Points in Upper Trapezius Muscle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
before application, exactly after treatment and one week after treatment
Method of measurement
by visual analog scale
2
Description
Pain Pressure Threshold
Timepoint
before application, exactly after treatment and one week after treatment
Method of measurement
by algometer
3
Description
range of motion
Timepoint
before application, exactly after treatment and one week after treatment
Method of measurement
by goniometer
Secondary outcomes
1
Description
disability
Timepoint
before application and week after treatment
Method of measurement
by Neck Disability Index
Intervention groups
1
Description
Intervention group: The intervention in this group is intramuscular electrical stimulation. The patient is in prone, while the hands are placed next to the body and the head is in the midline. For a patient's comfort, a roll under the forehead is used. The muscle is needled with a pincer palpation. The needle is inserted perpendicular to the skin and directed towards the practitioner’s finger. In the next step, the cathode electrode is connected to the needle and the other is placed by a circular electrode on the spinous process of seventh vertebra of neck. Then, a burst current (2 Hz frequency, 200µs pulse width) apply through the needles while electrical current steadily will be increased to meet a pain free contraction.The treatment is continued for a period of ten minutes.
control(placebo):
In placebo group procedure is exactly the same but there is no electrical stimulation under dry needling. The treatment is continued for a period of ten minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Tehran University of Medical Sciences
Full name of responsible person
Siamak Bashardoust Tajali
Street address
Faculty of Rehabilitation, piche shemiran st, Enghelab Ave, Tehran, Iran
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
monavar hadizadeh
Street address
Faculty of Rehabilitation, Piche shemiran st, Enghelab Ave, tehran, iran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
monavar hadizadeh
Position
master student
Other areas of specialty/work
Street address
Faculty of Rehabilitation, Piche Shemiran st, Enghelab Ave, Tehran, Iran
City
tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
hadizadeh-m@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Bashardoust Tajali
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Rehabilitation, Piche Shemiran st, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 2177685105253
Fax
Email
s_bashardoust@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Monavar Hadizadeh
Position
master student
Other areas of specialty/work
Street address
Faculty of Rehabilitation, Piche Shemiran st, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
hadizadeh-m@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)