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Comparative study of radial shockwave therapy and high intensity laser therapy in the treatment of patients with myofascial pain syndrome in neck and upper back area

Protocol summary

Study aim
Investigating and comparing the effects of radial shock wave therapy and high-power laser in the treatment of myofascial pain syndrome in the neck and upper back areas.
Design
A clinical trial without a control group, with parallel groups, one blinded, randomized, on 40 patients, random array subset selection (RASS) software and opaque sealed envelopes are used for randomization
Settings and conduct
The first group will receive radial shock wave therapy (ESWT: Extracorporeal shock wave therapy) in 3 sessions, 2 sessions per week with an intensity of 0.2 mj/mm2, a frequency of 10 Hz, a number of 1000 impulses along with simple pain relief exercises. The second group, high intensity laser therapy (HILT) in 5 sessions, 3 sessions per week, with a total energy output of 1060 joules divided into three phases of 500, 60 and 500 joules, intensity of 50 J/cm2 and average power: 3W (25) along with sports exercises and simple pain relief.Location: Kimia Physical Medicine and Rehabilitation Clinic,Tabriz
Participants/Inclusion and exclusion criteria
Entry requirements:Have at least two of the following criteria:1.Acute or chronic pain in the neck and shoulder muscles 2.The presence of trigger points and tight bands in the muscles around the neck and head more than 2 points 3.The appearance of referred pain in the peripheral muscle in response to pressure on the trigger point.Non-entry conditions:The presence of clear radiculopathy,discopathy,severe cervical degenerative changes,history of surgery or trauma and systemic diseases and malignancies
Intervention groups
The first group will receive radial shock wave therapy (Extracorporeal shock wave therapy) along with simple pain relief exercises. The second group, high intensity laser therapy along with sports exercises and simple pain relief
Main outcome variables
pain intensity؛neck disability index؛neck range of motion؛pressure pain threshold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100127003217N15
Registration date: 2023-11-01, 1402/08/10
Registration timing: registered_while_recruiting

Last update: 2023-11-01, 1402/08/10
Update count: 0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of radial shockwave therapy and high intensity laser therapy in the treatment of patients with myofascial pain syndrome in neck and upper back area
Public title
Comparative study of radial shockwave therapy and high intensity laser therapy in the treatment of patients with myofascial pain syndrome in neck and upper back area
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Acute or chronic pain in the neck and shoulder muscles The presence of trigger points and tight bands in the muscles around the neck and head more than 2 points The appearance of referred pain in the peripheral muscle in response to pressure on the trigger point
Exclusion criteria:
The presence of clear radiculopathy based on the history and the presence of one of the findings of radiculopathy in the form of weakness, radicular pain, or decreased reflexes, or upper limb sensation disorder, and a positive Spurling test The presence of extrude cervical discopathy proven in MRI The presence of severe cervical degenerative changes and the presence of radiculopathy History of cervical spine surgery or trauma Existence of systemic diseases such as bleeding disorders or rheumatological and cardiovascular diseases History of taking psychological drugs Pregnancy Malignancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Persons in a simple random way with random block method using 2 blocks and software random array subset selection (RASS) divided to two groups of shock wave and high power laser with a 1:1 allocation ratio using opaque sealed envelopes containing the numbers 1 and 2 in order to hide the process
Blinding (investigator's opinion)
Single blinded
Blinding description
The process of shock wave therapy and high-power laser is performed by a physiatrist and the assessment of patients before and after treatment is done by a resident of physical medicine and rehabilitation, who is unaware of the type of group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
Daneshgah Ave, executive field of Tabriz University of Medical Sciences, Vice-Chancellor for research of Tabriz University of Medical Sciences, University Ethics Committee
City
Tabriz
Province
East Azarbaijan
Postal code
5123698741
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.TBZMED.REC.1402.483

Health conditions studied

1

Description of health condition studied
Myofascial pain syndrome
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
Pain intensity
Timepoint
Before, immediately and 2 months after treatment
Method of measurement
Visual analogue scale ( VAS )

2

Description
neck disability index (NDI)
Timepoint
Before, immediately and 2 months after treatment
Method of measurement
Neck disability Index questionnaire

3

Description
Neck range of motion(ROM)
Timepoint
bubble inclinometer
Method of measurement
Before, immediately and 2 months after treatment

4

Description
pressure pain threshold (PPT)
Timepoint
Before, immediately and 2 months after treatment
Method of measurement
Algometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group, radial shock wave therapy (ESWT: Extracorporeal shock wave therapy) in 3 sessions, 2 sessions per week with an intensity of 0.2 mj/mm2, frequency of 10 Hz, number of 1000 impulses along with acetaminophen 500 mg and methocarbamol 500 mg every 12 hours for 10 days, upper trapezius stretching, isometric cervical paravertebral, posterior shoulder capsule stretching, and shrug exercises will be taught in three to ten sets during the treatment period of up to 6 weeks to be performed at home.
Category
Treatment - Devices

2

Description
Intervention group: The second group, high intensity laser therapy (HILT) in 5 sessions, 3 sessions per week, with a total energy output of 1060 joules divided into three phases of 500, 60 and 500 joules, intensity 50 J/cm2 and average power: 3W along with acetaminophen 500 mg and methocarbamol 500 mg every 12 hours for 10 days and upper trapezius stretching exercises, isometric cervical paravertebral stretching, posterior shoulder capsule stretching and shrug exercise in three to ten sets during the treatment period They will be trained for up to 6 weeks to do at home
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Fariba Eslamiyan
Street address
Department of physical medicine and rehabilitation, Imam Reza hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5698745213
Phone
+98 41 3336 1928
Email
eslamiyanf@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
Vice Chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5963876952
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hiva Shadmani
Position
Resident of physical medicine and rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5698745213
Phone
+98 41 3336 1928
Email
H.shadmany@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Golgasht Ave.,Imam Reza Hospital,Department of Physical Medicine and rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 3967
Fax
+98 41 3337 3967
Email
eslamiyanf@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
هیوا شادمانی
Position
Resident of physical medicine and rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave
City
اذربايجان شرقي
Province
East Azarbaijan
Postal code
5698745213
Phone
+98 41 3336 1928
Email
H.shadmany@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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