Protocol summary

Summary
This study aimed to compare the effects of muscle energy technique with low-level laser on reducing neck and shoulder pain and disability in patients with myofascial trigger points in upper trapezius and levator scapula.This double- blind randomized controlled trial was performed in Zahedan University of Medical Sciences, in 2009. Thirty patients with trigger points in upper trapezius and levator scapula were participated through simple non probability sampling. Patients were randomly assigned to one of three groups, 10 in each group: including muscle energy technique, low-level laser, and placebo groups. In laser group, a low-level Ga-As laser was applied with 5 KHz frequency, a 100 mW point probe (average power), wavelength 905 nm, pulse duration 200 ns, 6 J/cm2 dosages per minute, for 3 minutes duration. In muscle energy group, we used stretching after post_ isometric relaxation. Placebo group treated using low-level laser without output. A 10 session treatment program, during two weeks, five sessions per week was performed for all groups. Before and after intervention, we assessed neck disability with Neck Disability Index, neck pain with Visual Analogue Scale and shoulder pain and disability with Shoulder Pain and Disability Index and cervical ranges of motion with specific neck goniometer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011281675N3
Registration date: 2011-01-20, 1389/10/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-01-20, 1389/10/30
Registrant information
Name
Asghar Akbari
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1322 8445
Email address
akbaria@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2009-04-06, 1388/01/17
Expected recruitment end date
2009-12-21, 1388/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between muscle energy technique with low-level laser in reducing neck and shoulder pain and disability in subjects with trapezius and levator scapula myofascial trigger points
Public title
A comparison between muscle energy technique with low-level laser in reducing neck and shoulder pain and disability in subjects with trapezius and levator scapula myofascial trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-25, having trigger point in trapezius and levator scapula muscles with main complaint: muscle pain without neurological sign, no history of respiratory diseases, surgery, and neck & thoracic spine structural disorders. Exclusion criteria: no completion of the treatment, using other therapeutic modalities during study, trauma and surgery during the study.
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
no registration
Secondary trial Id
no trial id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Payam-e- Noor University
Street address
No 233, Cross of Sepand, Shahid nejatolahi St.,
City
Tehran
Postal code
Approval date
2011-01-08, 1389/10/18
Ethics committee reference number
1411/3030

Health conditions studied

1

Description of health condition studied
subjects with trigger points in upper trapezius and levator scapula
ICD-10 code
M62
ICD-10 code description
Other soft tissue disorders

Primary outcomes

1

Description
Neck pain
Timepoint
Before intervention, 2 weeks after intervention
Method of measurement
Visual Analogue Scale

2

Description
Neck disability
Timepoint
Before intervention, 2 weeks after intervention
Method of measurement
Neck Disability Index

3

Description
Shoulder pain and disability
Timepoint
Before intervention, 2 weeks after intervention
Method of measurement
Shoulder Pain and Disability Index

4

Description
Cervical ranges of motion
Timepoint
Before intervention, 2 weeks after intervention
Method of measurement
Specific neck goniometer

Secondary outcomes

1

Description
No secondary outcome
Timepoint
No secondary outcome
Method of measurement
No secondary outcome

Intervention groups

1

Description
A low-level Ga-As laser was applied with 5 KHz frequency, a 100 mW point probe (average power), wavelength 905 nm, pulse duration 200 ns, 6 J/cm2 dosages per minute, for 3 minutes duration
Category
Rehabilitation

2

Description
Muscle energy technique: stretching after post_ isometric relaxation.
Category
Rehabilitation

3

Description
low-level laser without output
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razmejo-Moghadam physiotherapy clinic, Zahedan
Full name of responsible person
Dr. Asghar Akbari
Street address
Razmejo-Moghadam Laboratory, School of Rehabilitation Sciences, Zahedan University of Medical Sciences, Ayatoallah Kafami St.
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Street address
Zahedan University of Medical Sciences, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Associate Professor, Head of Dept. of Physiotherapy, PhD, Deptuy of education and research of school
Other areas of specialty/work
Street address
Razmejo-Moghadam Laboratory, School of Rehabilitation Sciences, Zahedan University of Medical Sciences, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1325 8445
Fax
Email
akbari_as@yahoo.com, akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Associate Professor, PhD of physiotherapy
Other areas of specialty/work
Street address
Department of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1322 8445
Email
akbari_as@yahoo.com, akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Associate Professor, Head of Dept. of Physiotherapy, PhD of physiotherapy
Other areas of specialty/work
Street address
Department of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
Email
akbari_as@yahoo.com, akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

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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