Protocol summary

Summary
Goal: In this single-blinded study we plan to compare two methods of physical therapy (kinesiotaping and dry-needling) with stretch that is the golden standard treatment of muscle spasm and we assess lumbar range of motion and pain. Inclusion and exclusion criteria: Professional soccer players who have lumbar muscle cramps during exercise and Have moderate to severe pain in the lower back and their forward flexion are limited. We exclude them if they have history of lumbar problem and in the dry needling group we exclude people if they have used anti-clotting drugs. Study population and sample size: Enter 33 professional soccer players in three groups (kinesiotaping, dry needling and stretching) by block randomization method. Intervention: Each patient is treated three times for three days. Pain and range of motion measure for three times (before first session, immediate after first session and the end of last session). In the kinesiotaping group: We use this method on the low back muscle and stay on the skin for three days. In the dry needling group: We use deep dry needling for three session for three days in the intended muscle. In the stretch group: Stretch intended muscle three time a day and each time they stretch muscle for 10 times and each stretch hold for 30 seconds and do it for three days.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020724149N34
Registration date: 2017-02-26, 1395/12/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-26, 1395/12/08
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-07-16, 1395/04/26
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effectiveness of Kinesio taping and Dry Needling with routine method, in treatment of back muscle spasm in professional Soccer players
Public title
To compare the effectiveness of two Physical Therapy methods in treatmet of low back pain in professional Soccer players
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Professional soccer player; Age 17-33; Vas 4 – 7.5; Has pain because of low back muscle spasm; Mild or moderate spasm Exclusion criteria: Dissatisfaction, History of chronic low back pain; Using NSAID before treatment; Using aspirin in the dry needling group; Malignancy; Spondylolisthesis; History of back surgery; Congenital deformity in back.
Age
From 17 years old to 33 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences.
Street address
Zand Street
City
Shiraz
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SUMS.REC.1395.75

Health conditions studied

1

Description of health condition studied
low back muscle spasm
ICD-10 code
s39.0
ICD-10 code description
Injury of muscle and tendon of abdomen, lower back and pelvis

Primary outcomes

1

Description
Pain
Timepoint
Before,Immediate and End of three days
Method of measurement
VAS

2

Description
lumbar Range of Motion
Timepoint
Before,Immediate and End of three days
Method of measurement
Meter.The patient bend forward as far as possible and we measure distance between fingers and ground

Secondary outcomes

empty

Intervention groups

1

Description
Dry Needling group (Interventional): The patient lies in a prone position. Needles inserted through the skin into areas of the extensor muscles of back (Manipulated deeply in the muscle, use this technique for 3days)
Category
Rehabilitation

2

Description
Kinesiotaping group (Interventional): The Kinesiotape (I strip, tension: 25-50%) applied over the area of back muscles (in stretching position) which have spasm.
Category
Rehabilitation

3

Description
Stretching group (Control): Patient lie down in supine position and flex their knees to his abdomen, hold this position for 30 second and do that for 3 sets a day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
New Barq Football Club
Full name of responsible person
Mohammad Reza Hosseini
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice chancellor for research, Central Building of Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Science
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
SUMS School of Rehabilitation Science
Full name of responsible person
Iman Faghihzade Gorji
Position
Masters Student
Other areas of specialty/work
Street address
Ferdowsi Ave.
City
Shiraz
Postal code
Phone
+98 939 889 7989
Fax
Email
IMAN_faghih_gorji@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
SUMS School of Rehabilitation Science
Full name of responsible person
Fahimeh Kamali
Position
Assosiated Professor
Other areas of specialty/work
Street address
Abiverdi Ave.
City
Shiraz
Postal code
Phone
+98 917 711 0341
Fax
Email
fahimehkamali@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
SUMS School of Rehabilitation Science
Full name of responsible person
IMAN Faghihzade Gorji
Position
Masters Student
Other areas of specialty/work
Street address
Ferdowsi Ave.
City
Shiraz
Postal code
Phone
+98 939 889 7989
Fax
Email
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
Loading...