Evaluation of the effect of dry needling on the upper trapezius muscle on the postural control and balance
Design
A concealed, randomized, Double blinded, sham controlled clinical trial with a parallel group design of 30 patients.
Settings and conduct
This study will be conducted at the Neuromuscular Rehabilitation Research Center. Thirty patients with chronic neck pain will randomly assigned into two groups and in the experimental group, the participants will intervened via dry needling for 3 sessions one day apart, and the outcome measures will be evaluated for three times. The control group will be evaluated 3 times exactly the same as the experimental group. Patients and evaluator will be blinded about the allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The presence of chronic neck pain; trigger point in the upper trapezius muscle; pain more than 3 months; presence of neck pain between 3-6; presence of neck disability higher than 10
Non-inclusion criteria: The presence of any musculoskeletal problems in the lower extremities and balance impairment; diabetes; hemophilia; fear of needle; use of anticoagulants; pregnancy; any muscle involvement and the presence of trigger points in other muscles of the trunk
Intervention groups
Intervention group:15 individuals will be intervened via dry needles for 3 sessions with one day among them. Patients will be asked to lie prone position and then the trigger points of upper trapezius muscle will be intervened via the needle for 2 minutes. Before treatment, immediately after treatment, and 10 days after treatment, the range of motion, disability index and postural control parameters will be evaluated.
Control group: 15 patients will be evaluated for 3 times exactly in the same way as the experimental group.
Main outcome variables
Pain; disability; neck range of motion; center of pressure parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029264N5
Registration date:2019-07-01, 1398/04/10
Registration timing:prospective
Last update:2019-07-01, 1398/04/10
Update count:0
Registration date
2019-07-01, 1398/04/10
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dry needling of upper trapezius trigger point on postural control parameters in patients with chronic neck pain
Public title
The effect of dry needling on neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic neck pain more than 3 month
Presence of trigger point in the unilateral upper trapezius muscle
Neck disability index more than 10
Pain intensity between 3 and 6
Exclusion criteria:
Any neurogenic pain and radiculopathy, cardiovascular disorders, diabetes, hemophilia
Fibromyalgia syndrome
Any musculoskeletal disorders in the lower limbs
pregnancy
Needle phobia
Infection and edema in the treatment area
Consumption of anticoagulant drugs
Presence of trigger point in the other muscles of cervical and trunk regions
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in this study are not aware of the allocation of dry needles or control groups.
The researcher does not know the allocation of participants in the intervention and control groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.SEMUMS.REC.1398.056
Health conditions studied
1
Description of health condition studied
Neck pain
ICD-10 code
M99.01
ICD-10 code description
Segmental and somatic dysfunction of cervical region
Primary outcomes
1
Description
Pain
Timepoint
Before, immediately and 10 days after the dry needling
Method of measurement
100 mm visual pain scale
2
Description
Disabiity
Timepoint
Before, immediately and 10 days after the dry needling
Method of measurement
Disability questionnaire
3
Description
Range of motion
Timepoint
Before, immediately and 10 days after the dry needling
Method of measurement
Goniometer
Secondary outcomes
1
Description
Parameters of foot center of pressure
Timepoint
Before, immediately and 10 days after the dry needling
Method of measurement
Force plate
Intervention groups
1
Description
Intervention group: A 0.30 * 50mm acupuncture needle will used using piston method for 2 minutes at each trigger point for at least 5 points on the upper trapezius muscle. This treatment will take place within 3 sessions and one day apart.
Category
Rehabilitation
2
Description
Control group: There will be no intervention in this group and all of the parameters studied will be evaluated in the same way as the experimental group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center,. Semnan University of Medical Scinces., Semnan., Iran.
Full name of responsible person
Dr Parviz Kokhaei
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3336 4180
Fax
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Basij Blvd, Semnan, Semnan Province.
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Maryam Mahdizadeh Langeroudi
Position
Master Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.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