Protocol summary

Summary
Epidemiologic studies of musculoskeletal pain syndromes show that myofascial trigger point (MTP) pain is very common. More than 55% of neck pain and 85% of lumbar and back pain are MTP. the goal of this study is to examine the effectiveness of polarized low-level laser therapy (PLLLT) in reduction of cervical neck and back MTPs. We also compared its effectiveness in pain control with LLLT. Sixty patients with MTPs are selected from patients who referred themselves to Ali-ibn Abi Talib Hospital in Rafsanjan. Patients were randomly divided into two equal groups, PLLLT and LLLT. Each patient receive treatment for a period of 2 weeks, 5 sessions a week. The intensity of laser irradiation to the skin surface is 6 J/cm2. The system exit power is 160 mw at 755 nm wavelength. The Visual Analog Scale (VAS) for the 1st, 5th and 10th sessions is analyzed through two-way repeated measures ANOVA. In addition, Radicular pain (RP), limitation of neck movement (LNM), presence of muscular taut band (PMTB) and sensitivity of muscular taut band (SMTB) the end of the 10th session are compared with participants’ condition at the beginning of the 1st session in both groups. this study is conducted in a double blind ( Participants and the evaluating physiotherapist)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081623647N1
Registration date: 2015-09-10, 1394/06/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-10, 1394/06/19
Registrant information
Name
Seyed Ali Shafiei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 6143
Email address
sashafiei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences,
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Polarized Low-Level Laser on Treatment of Myofascial Trigger Points of the Trapezius Muscles
Public title
Effect of Low-Level Laser in Pain Relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Existence of all major criteria: local pain; radicular pain originating from trigger points; presence of tangible and taut muscular band in involved muscles; reduction in the range of motion and sensitivity along the length of the taut band. At least one of the minor criteria: creation of fast muscular contraction response; spontaneous alteration of pain sensation when pressing trigger points; muscular pain associated with strain.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Rafsanjan University of Medical Sciences.
Street address
Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
2688/9

Health conditions studied

1

Description of health condition studied
Patients with myofascial trigger points (MTPs) in the trapezius muscles
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
Pain intensity
Timepoint
The 1st, 5th and 10th sessions
Method of measurement
Visual Analog Scale ( VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Plarized low-level laser therapy group: Each patient receives treatment for a period of 2 weeks, 5 sessions a week. The intensity of laser irradiation to the skin surface is 6 J/cm2.
Category
Treatment - Other

2

Description
low-level laser therapy group: Each patient receives treatment for a period of 2 weeks, 5 sessions a week. The intensity of laser irradiation to the skin surface is 6 J/cm2.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-ibn Abi Talib Hospital in Rafsanjan
Full name of responsible person
Seyed Ali Shafiei
Street address
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences,
Full name of responsible person
Mohammad Reza Mirzaie
Street address
School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyed Ali Shafiei
Position
Ph.D
Other areas of specialty/work
Street address
Medical Physics & Genetics Department, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
Phone
+98 34 3428 6143
Fax
Email
sashafiei@rums.ac.irsalishafiei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyed Ali Shafiei
Position
Ph.D
Other areas of specialty/work
Street address
Medical Physics & Genetics Department, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
Phone
+98 34 3428 6143
Fax
Email
salishafiei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyed Ali Shafiei
Position
Ph.D
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
salishafiei@yahoo.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
Loading...