(1) Objective: The aim of this study is to compare aerobic training and acupuncture with acupuncture alone in treatment of neck myofascial pain syndrome. (2) Design: In this study, 60 patients with neck myofascial pain syndrome referring to physical medicine and rehabilitation clinics will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: Patients will be randomly divided to groups of thirty. For randomization we will use computerized randomization with Excel software. Inclusion criteria are pain in the neck and shoulder regions for more than two months, pain in more than 3 other trigger points in muscles around the neck and shoulder regions and willingness to participate in the study. Exclusion criteria are severe osteoarthritis of the knees or lumbosacral problems which prohibit the patient from doing aerobic training, systemic diseases which prohibit the patients for acupuncture or aerobic training, known allergy to metals, pregnancy and malignancies. (4) Interventions: Before initiating the study pain severity will be recorded as VAS score. Quality of life and neck disability questionnaire will be filled out too. Pain threshold in trigger points will be determined using a digital algometer device and a 4kg/cm2 pressure. This will be done three times with a 10 seconds interval. In control group, acupuncture will be performed for 10 sections weekly. In intervention group, in addition to acupuncture, in each section, aerobic training will be administered for 30 - 45 minutes using treadmill and exercise bicycle. (5) Main outcome measures: VAS score, quality of life and neck disability questionnaire scores and pain threshold will be evaluated before, after and one month after completing the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509264641N11
Registration date:2015-10-27, 1394/08/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of aerobic training and acupuncture and acupuncture alone in treatment of neck myofascial pain syndrome
Public title
Study of adding aerobic training to acupuncture in treatment of neck myofascial pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pain in the neck and shoulder regions for more than two months; pain in more than 3 other trigger points in muscles around the neck and shoulder regions; willingness to participate in the study.
Exclusion criteria: Severe radiculopathy based on radiculopathy symptoms such as weakness, radicular pain, decreased reflexes or upper limb sensory loss and a positive spurling test; cervical discopathy approved with MRI; severe osteoarthritis of the knees or lumbosacral problems which prohibit the patient from doing aerobic training; systemic diseases which prohibit the patients for acupuncture or aerobic training; known allergy to metals; pregnancy; malignancies.
Age
From 20 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Tabriz University of Medical Sciences
Street address
Ethics committee, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2014-07-10, 1393/04/19
Ethics committee reference number
92194
Health conditions studied
1
Description of health condition studied
Cervicalgia
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
Pain
Timepoint
Before study, after study, one month after study
Method of measurement
By using Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before study, after study, one month after study
Method of measurement
By using quality of life questionnaire
2
Description
Neck functional status
Timepoint
Before study, after study, one month after study
Method of measurement
By using neck disability index questionnaire
Intervention groups
1
Description
In control group, acupuncture will be performed for 10 sections weekly.
Category
Treatment - Devices
2
Description
In intervention group, in addition to acupuncture, in each section, aerobic training will be administered for 30 - 45 minutes using treadmill and exercise bicycle
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Bina Eftekharsadat
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hasan Soleimanpour
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square, Tabriz
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Elmira Pourjafari
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
Elishan02@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41333361928
Fax
Email
binasadat@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Elmira Pourjafari
Position
Physical medicine and rehabilitation resident
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)