Effects of dry needling technique (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle
Effects of dry needling technique in treating the active trigger points of the upper trapezius muscle
Design
Clinical trial with control group, experimental-interventional, convenience sampling, random allocation.
Settings and conduct
The target community is selected from the students of the Rehabilitation School who have active trigger points in upper trapezius muscle. Sampling method is non-random and allocation of samples to groups will be random. Sampling will be done at the Biomechanics Laboratory of the Faculty of Rehabilitation.In this study data analyzer will be blind.
The physiotherapist assesses the local pain intensity through (visual analog scale), active cervical contra lateral flexion using Goniometer and pressure pain threshold using algometer. Iranian version of neck disability index questionnaire will be used to determine the level of patient's ability.
Variables will be assessed at the first session before and after the intervention and the fourth session and fourth week after the end of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Subjects between 18 and 40 years,
Presence of active trigger points,
Pain at least 30 mm in visual analog scale,
Exclusion criteria:
History of whiplash injury,
History of head , neck , cervical spine or shoulder surgery,
History of cervical radiculopathy,
Diagnosed fibromyalgia and myopathy,
History of cancer,
Pregnancy,
History of treatment in a past month,
Contraindication of dry needling technique,
Intervention groups
Intervention group: Dry needlingTechnique , twice a week , For two weeks.
Control group: There is no intervention.
Main outcome variables
Pain intensity at the visual scale of pain,
Pressure pain threshold,
Active cervical contra lateral flexion,
Neck disability index,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180311039049N1
Registration date:2018-11-03, 1397/08/12
Registration timing:prospective
Last update:2018-11-03, 1397/08/12
Update count:1
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Zeinab Ahmadpour emshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 2736
Email address
z.ahmadpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dry needling technique (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle
Public title
Effects of dry needling technique (DN) on the active trigger points of the upper trapezius muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects between 18 and 40 years
Presence of active trigger points in upper trapezius muscle
Pain at least 30 mm in visual analog scale
Exclusion criteria:
History of whiplash injury
History of head , neck , cervical spine or shoulder surgery
History of cervical radiculopathy
Diagnosed fibromyalgia and myopathy
History of cancer
Pregnancy
Myofascial therapy within the past month
Contraindication of dry needling technique
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a sample of 50 people, 25 cards for intervention group and 25 cards for control group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
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
Myofascial Trigger Points of the Upper Trapezius Muscle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity in the visual scale of pain
Timepoint
Measure the severity of pain in the first session before and after the intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Pain pressure threshold
Timepoint
Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Digital algometer (Lutron FG-5020)
2
Description
Active cervical contra lateral flexion
Timepoint
Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Goniometry
3
Description
Neck disability index
Timepoint
Measurement at first session before intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Neck disability index- iranian version questionnaire
Intervention groups
1
Description
Intervention group:Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week.
Category
Treatment - Other
2
Description
Control group: There is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
The School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR. Farshad Okhovatian
Street address
Damavand Ave., Imam Hossein Square (AS)., Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
zeinab.ahmadpour1372@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Akbarzadeh Baghban
Street address
Damavand Ave., Imam Hossein Square (AS).,Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
zeinab.ahmadpour1372@Gmail.com
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
Zeinab Ahmadpour Emshi
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
zeinab.ahmadpour1372@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR. Farshad Okhovatian
Position
Professor
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
Farshadokhovatian1965@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeinab Ahmadpour Emshi
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences.,Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
zeinab.ahmadpour1372@Gmail.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