Protocol summary

Summary
Purpose of this study: A comparison study on the immediate effects of dry needling and static stretching on hamstring flexibility in healthy subjects with shortness of hamstring. Study design was randomize control trial. Participants recruited from the students of rehabilitation school of Tehran University of Medical Sciences. All participants signed an informed consent form prior to entrance in the study. And then 40 participants were assigned to either static stretch(20 subjects, 4=male and 16=female) or dry needling(20 subjects, 4=male and 16=female) through a random selection, which in turn was based on sortition. Outcome measurements included flexibility, passive compliance, passive peak torque and stretch tolerance before, immediately after and 15 minutes after intervention were measured. Inclusion criteria: Hamstring shortness ≥ 20° using the Active Knee Extension Test (AKET), ages between 18-40 years, no history of orthopedic/neurological disorders in the lower extremity, no history of low back pain for the last year. Exclusion criteria: Fear of needling, and not consenting to participate in this study. interventions include: dry needling and static stretching of hamstring muscles. Outcome measurements of this study were flexibility, passive compliance, passive peak torque and stretch tolerance

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112231018N1
Registration date: 2017-10-03, 1396/07/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Parisa Alaei
Name of organization / entity
Rehabilitation faculty of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5573 9139
Email address
p-alaei@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research of Tehran University of Medical Sciences
Expected recruitment start date
2016-12-19, 1395/09/29
Expected recruitment end date
2017-02-17, 1395/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study on the Immediate Effects of Dry Needling and Static Stretching on Hamstring Flexibility in Healthy Subjects with shortness of hamstring.
Public title
A comparison study on effects of dry needling and static stretching on hamstring flexibility.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hamstring shortness ≥ 20° using the Active Knee Extension Test (AKET); ages between 18-40 years; no history of orthopedic/neurological disorders in the lower extremity; no history of low back pain for the last year; no contraindication for using dry needling (e.g. pregnancy, diabetes mellitus); no joint limitation in the lower extremities. Exclusion criteria: Fear of needling; not consenting to participate in this study.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics institute in research of Tehran University of Medical Sciences
Street address
4th Floor, No. 23, before Pour Sina St. 16th Azar St. Keshavarz Blvd, Medical Ethics Section
City
tehran
Postal code
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1048

Health conditions studied

1

Description of health condition studied
hamstring tightness
ICD-10 code
M62.4
ICD-10 code description
Contracture of muscle

Primary outcomes

1

Description
Flexibility
Timepoint
Before, immediately after and 15 min after intervention
Method of measurement
Goniometer

2

Description
Passive compliance
Timepoint
Before, immediately after and 15 min after intervention
Method of measurement
Goniometer and hand held dynamometer

Secondary outcomes

1

Description
Passive peak torque
Timepoint
Before, immediately after and 15 minutes after intervention
Method of measurement
Hand held dynamometer

2

Description
Stretch tolerance
Timepoint
Before, immediately after and 15 minutes after intervention
Method of measurement
Goniometer

Intervention groups

1

Description
Dry needling includes using of 6 cm needle specified for dry needling. Three point of hamstring muscle will choose for needling. Duration of needling for each point is 1 minute. The needle was deeply inserted perpendicular to the skin using fast-in and fast out cone shape technique.
Category
Treatment - Other

2

Description
Static stretching includes a slow and passive stretching of hamstring muscles in position of Active Knee Extension test. Investigator ask the subject to endure as much stretching force as possible without pain. Static stretching lasted for 30 seconds. This sequence repeats 3 times with 10-second rest intervals between each trial.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
rehabilitation faculty of Thran University of Medical Sciences
Full name of responsible person
Dr. Nureddin Nakhostin Ansari
Street address
rehabilitation faculty of tehran university of medical science, Piche shemran, Enqelab st
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research in School of Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Shadmehr
Street address
Deputy of Research in School of Rehabilitation of TUMS, Piche shemiran, Enqelab st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research in School of Rehabilitation of Tehran 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
Rehabilitation faculty of Tehran University Of Medical Sciences
Full name of responsible person
Parisa Alaei
Position
performer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University Of Medical Sciences, Piche shemiran, Enqelab st
City
Tehran
Postal code
Phone
+98 21 5573 9139
Fax
Email
paris.alaei@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehabilitation faculty of Tehran University of Medical Sciences
Full name of responsible person
Dr. Nureddin Nakhostin Ansari
Position
Ph.D
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Piche shemiran, Enqelab st.
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
Email
nakhostin@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation faculty of Tehran University of Medical Sciences
Full name of responsible person
Parisa Alaei
Position
Performer
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Piche shemiran, Enqelab st.
City
Tehran
Postal code
Phone
+98 21 5573 9139
Fax
Email
paris.alaei@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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