The aim of this study was to compare the efficacy of two methods of Dry Needling and Shock Wave therapy on pain and dysfunction of active trigger points in the upper trapezius muscle
Design
Three arm parallel groups randomized clinical trial, single blinded, two-session treatment
Settings and conduct
48 patients with myofascial pain syndrome are admitted to the physiotherapy department of Nikan hospital after inclusion criteria. Using simple randomization, patients are divided into Shock wave, Shock wave Placebo and dry needling groups. All three groups receive two sessions of treatment per week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ages 18-35 years old; having trigger points active with a specified bundle in the upper trapezius muscle; pain above 3 and less than 7 on the VAS scale; pain one to three months; refferal pain.
Exclusion criteria: performing injections or other treatments for trigger points during the research period; having a previous history of infectious diseases such as fibromyalgia and myopathy; malignancy or patients susceptible to infection; presence of central and peripheral neurological disorders; use of anticoagulants; having vascular diseases; fear of needling; skin ulcers in the treatment area.
Intervention groups
Shock wave Group: Upper Trapezius Muscle Shock Therapy is performed with 1000 impulses, 700 pulses on the Taut band of the Trapezius muscle and 300 pulses around the Taut band.
Shock wave Group Placebo: In this group, the shock wave setting is as same as Shock wave Group without any impulse to the muscle.
Dry needling Group: After inserting the needle into the muscle and observing the first twitch of the needle, leave it in the muscle for 5 minutes.
Main outcome variables
Pain; pain pressure threshold; disability based on NDI scale; lateral neck flexion range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043588N1
Registration date:2019-12-29, 1398/10/08
Registration timing:retrospective
Last update:2019-12-29, 1398/10/08
Update count:0
Registration date
2019-12-29, 1398/10/08
Registrant information
Name
Mehran Toghtamesh
Name of organization / entity
Medical University Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 7757 0616
Email address
mehrantoghtamesh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Dry Needling Versus Shock Wave Therapy on Pain and Dysfunction Following Active Trigger Points in Upper Trapezius Muscle
Public title
Comparison of the Effects of Needling and Shock Wave Therapy on Active Trigger Points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35
Having active trigger points with a distinct bundle in the upper trapezius muscle
Touch the Taut Band on the upper trapezius muscle fibers
Pain above 3 and less than 7 on the VAS scale
Pain for one to three months
Having refferal pain
Exclusion criteria:
Performing injections or other treatments for trigger points during the research period
Having a previous history of infectious diseases such as fibromyalgia and myopathy
Malignancy or patients susceptible to infection
Presence of central and peripheral neurological disorders
Use of anticoagulants
Having vascular diseases
Fear Of Needle
Skin ulcers in the treatment area
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into one of three groups under study using encoded pocket.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are blind to the treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Faculty of Rehabilitation, Tehran University of Medical Sciences, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2019-08-07, 1398/05/16
Ethics committee reference number
IR.TUMS.FNM.REC.1398.092
Health conditions studied
1
Description of health condition studied
Myofascial pain syndrome
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
Pain
Timepoint
At baseline and immediately after the first session and after the second session
Method of measurement
Visual Analog Scale
2
Description
Pressure Pain Threshold
Timepoint
At baseline and immediately after the first session and after the second session
Method of measurement
Algometer
3
Description
Lateral bending Of Neck
Timepoint
At baseline and immediately after the first session and after the second session
Method of measurement
Goniometer
4
Description
Disability
Timepoint
Beginning and end of treatment
Method of measurement
Neck Disability Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Dry Needling : In this group, needle enters the upper trapezius muscle trigger point and stays in the muscle for 5 minutes. Two treatment sessions with a 48 hour interval during a week.
Category
Treatment - Other
2
Description
Shock Wave Therapy: In this group, shockwave with a power of 38 mJ / mm2 and frequency of 10 Hz is applied to the upper trapezius muscle with 1000 impulses and two sessions of therapy with 48 h intervals during the week.
Category
Treatment - Other
3
Description
Placebo Shock Wave Therapy: In this group, a shockwave with a power of 38 mJ / mm2 and a frequency of 10 Hz is applied to the upper trapezius muscle without any impulse and two treatment sessions with 48 h intervals during the week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikan Hospital
Full name of responsible person
Mehran Toghtamesh
Street address
Department of Physiotherapy, Nikan Hospital, 22 Bahman Ave., Army Boulevard
City
Tehran
Province
Tehran
Postal code
1694636517
Phone
+98 21 2912 1018
Email
mehrantoghtamesh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nikan hospital
Full name of responsible person
Dr. Mehdi Shiravi
Street address
Department of Physiotherapy, Nikan Hospital, 22 Bahman Ave., Army Boulevard
City
Tehran
Province
Tehran
Postal code
9435114679
Phone
+98 21 2912 1018
Email
mehrantoghtamesh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nikan hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehran Toghtamesh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Nikan Hospital, 22 Bahman Ave., Army Boulevard
City
Tehran
Province
Tehran
Postal code
9435114679
Phone
+98 21 2912 1018
Email
mehrantoghtamesh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehran Toghtamesh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Nikan Hospital, 22 Bahman Ave., Army Boulevard
City
Tehran
Province
Tehran
Postal code
9435114679
Phone
+98 21 2912 1018
Email
mehrantoghtamesh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehran Toghtamesh
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Nikan Hospital, 22 Bahman Ave., Army Boulevard
City
Tehran
Province
Tehran
Postal code
9435114679
Phone
+98 21 2912 1018
Email
mehrantoghtamesh@yahoo.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