Protocol summary

Summary
The purpose of this study was to compare the effects of diclofenac phonophoresis with ergonomic instructions on reducing neck and shoulder pain and disability in women with myofascial trigger points in trapezius muscle. This randomized controlled trial was performed in Zahedan University of Medical Sciences, in 2009. Thirty patients with trigger points in trapezius muscle were participated through simple non probability sampling. Patients were selected based on following inclusion criteria: Age between 18-25, having trigger point in trapezius muscles with main complaint: muscle pain without neurological sign, no history of respiratory diseases, surgery, and neck & thoracic spine structural disorders. Patients were excluded if they had insufficient treatment, using other therapeutic modalities during study, trauma and surgery during the study. Patients were randomly assigned to one of three equal groups: diclofenac phonophoresis, ergonomic instructions, and control groups. In phonophoresis group, frequency of ultrasound 1 MHz, continuous mode, intensity 1.5 W/cm2 and duration 4.5 min was used. Ergonomic group received instructions in order to maintain appropriate posture during activity of daily livings. Control group received ultrasound without output. A 12 session treatment program, during 4 weeks, 3 sessions per week was performed. Before and after intervention, we assessed neck pain with Northwick Park Neck Pain Questionnaire and shoulder pain and disability with Shoulder Pain and Disability Index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112261675N10
Registration date: 2012-02-01, 1390/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-01, 1390/11/12
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
Vice Chancellor for Research, Zahedan University of Medical Sciences.
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of diclofenac phonophorosis and ergonomic instructions on reducing neck and shoulder pain in women with myofascial trigger points in trapezius muscle
Public title
A comparative study of diclofenac phonophorosis and ergonomic instructions on reducing neck and shoulder pain in women with myofascial trigger points in trapezius muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-25, having trigger point in trapezius 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
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
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
no registration
Secondary trial Id
no trial id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of University of Sistan and Baluchestan
Street address
Daneshgah Blvd., University of Sistan and Baluchestan
City
Zahedan
Postal code
987-98155
Approval date
2012-01-08, 1390/10/18
Ethics committee reference number
902.21.245

Health conditions studied

1

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

Primary outcomes

1

Description
Neck pain
Timepoint
Before intervention,4 weeks after intervention
Method of measurement
Northwick Park Neck Pain Questionnaire

2

Description
Shoulder pain and disability
Timepoint
Before intervention,4 weeks after intervention
Method of measurement
Shoulder Pain and Disability Index

Secondary outcomes

1

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

Intervention groups

1

Description
Diclofenac phonophoresis group: In phonophoresis group, frequency of ultrasound 1 MHz, continuous mode, intensity 1.5 W/cm2 and duration 4.5 min for diclofenac phonophoresis was used.
Category
Rehabilitation

2

Description
Ergonomic instructions group: Ergonomic group received instructions in order to maintain appropriate posture during activity of daily livings.
Category
Rehabilitation

3

Description
Control group: Ultrasound without output
Category
Rehabilitation

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmoudzadeh Sagheb
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq., Zahedan.
City
Zahedan
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 of 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
Ph.D in Physiotherapy, Head of Dept. of Physiotherapy.
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1342 4675
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
Ph.D in Physiotherapy, Head of Dept. of Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
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

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Head of Dept. of Physiotherapy, Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
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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