This single center clinical trial will be done for comparing the effects of shock wave (SW) and dry needling (DN) on clinical symptoms of upper trapezium trigger points (MTrPs). In this study, 40 patient with active MTrPs of upper trapezius muscle and with no specific neck or shoulder pain are selected and divided randomly into two groups using Randomized Allocation Software. In one group DN and in other group SW will be used. The patients with myofacial pain syndrome in Trapezius muscle with pain intensity 30 - 60 in VAS scale for 3 months are included. If they have any other musculoskeletal problem or use any other intervention for their problem, they will be excluded.
Evaluation of treatment effects will be performed using a visual analog scale (VAS), pressure pain threshold (PPT) and neck disability index questionnaire in patient with neck pain. In both groups these variables are measured before the first treatment session and before of the second, third and fourth treatment sessions and also seven days following the last treatment session.
Patients in both groups will participate in four treatment sessions (With an interval of three days between each session) during two weeks.
During treatment sessions and before each intervention, two variables (PPT, VAS) are measured by first examiner.
The order of these measurements in each session is determined randomly. According to target group, treatment method is performed by second examiner. At the end of each session evaluation of patients is executed by first examiner again. In both groups, results of treatment methods will be reevaluated seven days following the last treatment session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110318760N3
Registration date:2016-12-16, 1395/09/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-16, 1395/09/26
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Tabriz University of Medical Science
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trail to compare the effects of shock wave and dry needling on clinical symptoms of upper trapezium trigger points
Public title
The comparison between the effects of shock wave and dry needling on trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: myofacial pain syndrome in Trapezius muscle; pain intensity 60 -30 in VAS scale for 3 months.
Exclusion criteria:contraindication of ESWT or dry needling; Pregnancy; Previous injection in MTrPs; Having had previous surgery in the neck or upper limb; Using anticoagulant drugs; advance osteopathic or arthropathic disorders of the cervical spine or the shoulder; Having ulcer in therapy region; Using the anti-pain drugs in last 24 hours; Having specific postural dysfunction
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization with Randomized Allocation Software (RAS)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee of Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Daneshgah Ave., Tabriz
City
Tabriz
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.TBZMED.REC.1395.762
Health conditions studied
1
Description of health condition studied
Myofacial Trigger Point Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pressure pain threshold (PPT)
Timepoint
Each treatment sesstion and one week after the last sesstion
Method of measurement
digital algometer
2
Description
Pain Intensity
Timepoint
Each treatment sesstion and one week after the last sesstion
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Disability
Timepoint
Each treatment session and one week after the last sesstion
Method of measurement
neck disability index questionnaire (NDI)
Intervention groups
1
Description
Control group: Shock wave 0.025 mJ/mm2 , 1000 shocks per session for 4 session, once a week. Shock wave is a method of treatment in which mechanical shocks are applied on tender or trigger points to break these points and release adhesions.
Category
Rehabilitation
2
Description
Intervention group: Dry needling is applied for upper trapezius trigger points for 4 session and each session runs once a week. Dry needling is a treatment method in which fine needles are inserted into trigger points to release adhesions and there is no injection in this method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Clinic of Rehabilitation Faculty, Tavanir ave., Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohhamad Reza Rashidi
Street address
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences, Daneshgah Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research (VCR) of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
PhD, Faculty member
Other areas of specialty/work
Street address
Rehabilitation Faculty, Tavanir ave., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3333 4647
Fax
Email
ghaderif@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
PhD,Faculty member
Other areas of specialty/work
Street address
Rehabilitation Faculty, Tavanir ave., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3333 4647
Fax
Email
ghaderif@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
PhD, Faculty member
Other areas of specialty/work
Street address
Rehabilitation Faculty, Tavanir ave., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3333 4647
Fax
Email
ghaderif@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)