Protocol summary

Study aim
Comparison of the immediate and delayed effects of two methods of fast in fast out and winding dry needling in Gastrocnemius muscle trigger points on lower extremity function and pain in non-professional athletes
Design
One blind clinical trial will performed on two groups including control group with needles in a piston method, and the second group in a needle rotation method, which was randomized with software. Sample size will be 60 subjects.
Settings and conduct
Participants will be male athletes at the level of the sports clubs and sports teams of Semnan, who will have Gastrocnemius muscles trigger points . participants are divided into two groups which are blinded to other group. The groups will treated with two needle techniques. The jumping height will measured by the camera of motion analysis at the intervals before and after the treatment, at intervals of 24, 48, 72 hours and four weeks after treatment. The intensity of the pain will also measured based on the visual analog scale of pain before, during treatment, after treatment, and 24, 48, 72 hours, four weeks after treatment.
Participants/Inclusion and exclusion criteria
subjects will selected by examination. The presence of fibrous bundles in the muscle, sensitivity to touch, the presence of palpable or visible muscle fasciculation in the palpation and pain in posterior region of the leg while walking or running without morning symptoms that can be radicular or constant. Participants should have moderate pain intensity and based on the visual scale, the pain should be between 3 and 6. They should be athletes and running, jumping, abrupt change, fast running should be main component of their sports.they should have training at least two days a week.
Intervention groups
Individuals will divided into two groups. fast in fast out group and winding needling group
Main outcome variables
Pain and jumping height will be evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160424027562N9
Registration date: 2019-05-25, 1398/03/04
Registration timing: registered_while_recruiting

Last update: 2019-05-25, 1398/03/04
Update count: 0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Roghayeh Mohammadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
mohammadipt@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Immediate and Delayed Effects of Two Methods of Fast in fast out and Winding Dry needling in Gastrocnemius Muscle Trigger Points on Lower Extremity Function and Pain in Non-professional Athletes
Public title
The effect of dry needling on jumping and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of fibrous bundle Touch sensitivity The presence of local or visible muscle fasciculation in palpation The presence of pain in the posterior region of leg muscles during walking or running without morning symptoms that can be radicular or constant Individuals should be athlete and running, jumping, sudden redirect and fast running should be the main components of their sports. They should practice at least two days a week Squatting should be part of their training program The participants should have moderate pain intensity and a VAS of between 3 and 6
Exclusion criteria:
Hypothyroidism Connective tissue tumor Anticoagulant drugs Blood disorders Local or diffuse infection Skin lesions, swelling, immune system disorders, vascular dysfunction and fear of dry needling History of any damage and treatment of vertebral column and lower extremity in the past three months The presence of 11 to 13 sensitive points that are indicative of fibromyalgia The presence of painful and sensitive points in other regions of lower extremity and trunk
Age
From 16 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure that two groups are matched in terms of sex as well as to achieve a complete randomized and balanced assignment, we will use stratified randomization method (layered) by stratified permuted block randomization. So individuals are divided into two stratum of male and female and for each stratum, a separate random assignment is continued until the optimal sample size is reached. For a random assignment in each stratum based on the sequences of the two methods A and B, six blocks are defined as follows and numbered from 1 to 6 respectively: AABB- BBAA- ABAB- ABBA- BABA- BAAB Then, blocks of random numbers are randomly selected by numbers 1 to 6. (numbers 0 and 7 to 9 are not the criteria for the decision). Thus, the type of intervention for each five people is determined respectively. Random allocation software will be used to construct the encryption tag, and then we will use the enclosed packet to hide it randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the participants, the details of technique will not be explained for them and only the explanation of trigger points treatment by needling will be clarified. Also the individuals of each group will not be informed of the existence of the other group, to achieve this purpose, two groups will be visited on different days to get treatment and record jumping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.SEMUMS.REC.1397.307

Health conditions studied

1

Description of health condition studied
Myofascial trigger point
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Vertical jumping
Timepoint
At the beginning of the study, 24, 48, and 72 hours, also four weeks after applying the needle dry technique
Method of measurement
Motion analysis system

Secondary outcomes

1

Description
Pain
Timepoint
At the beginning of the study, 24, 48, 72, and four weeks after applying the needle dry technique
Method of measurement
Visual analogue scale

Intervention groups

1

Description
Control group: This group receives the usual dry needling method. Dry needling is applied to the trigger points of the Gastrocnemius muscle by means of a piston method. In this group, initial evaluations and the jumping base are recorded. The next day, the patient finds a dry needling at a depth of 3 cm on trigger points. In this method, the needle is 0.25 mm in diameter and 5 cm in length, and the needle enters the trigger point after passing through the skin, then it is removed to close the skin and then into a slightly spaced fan shape applied on trigger points, This will continue until muscle twitching is seen. After the twitch muscle is visible, it remains in the trigger point for ten minutes.Then the needle is removed and three jumps are taken from the participant, jump height is recorded by the motion analyzer. This device is a Qualysis brand and is made in the sweden country. The vertical jump is recorded by two cameras and the recording frequency is 100 Hz . Average jumps will be compared with the second intervention group.
Category
Rehabilitation

2

Description
Intervention group: This group receives the dry needle rotation method. In this group, initially, initial evaluations and the jump base are recorded. The next day, the patient finds a dry needle at a depth of 3 cm on trigger points. In this method, the needle is 0.25 mm in diameter and 5 cm in length. The needle passes through the skin and enters the trigger points. After insertion of the needle with a frequency of two Hz for 30 seconds in the opposite direction We turn the clock and rest for thirty seconds. It will be repeated for ten minutes. Then the needle is removed and three jumps are taken from the participants, jump height is recorded by the motion analyzer. This device is a Qualysis brand and is made in the sweden country. The vertical jump is recorded by two cameras an The recording frequency is 100 Hz . Average jumps will be compared with the second intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Roghayeh Mohammadi
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mohamadipt@gmail.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
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.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
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Fax
Email
mohamadipt@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after being unidentified.
When the data will become available and for how long
The beginning of the access period is one month after the results are published.
To whom data/document is available
All those who need research results can receive the study documentation.
Under which criteria data/document could be used
All people who use the information are required to mention the source
From where data/document is obtainable
To receive the information, they can contact the research author at the Faculty of Rehabilitation, Semnan University of Medical Sciences.
What processes are involved for a request to access data/document
After receiving the email from the applicant, the applicant will be sent a document within two weeks
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