The purpose of this study is to compare the effects of acupuncture and low level laser in the treatment of myofascial neck pain syndrome. This is a single-blind, randomized clinical trial. We will recruit the patients that have neck pain for more than 2 months and do not have systemic diseases, radicular pain, history of fracture or surgery in the cervical spine, severe disc herniation in the previous MRI or EMG or severe degenerative changes of cervical spine in the radiography, then randomly divide them into 3 groups. Study population is 60 patients. Then tender and trigger points will be diagnosed with examination of the neck and their sensitivity is graded from 0 to 2+. Pain intensity is evaluated with VAS and quality of life with "NorthWick Park" questionnaire. Cervical ROM in frontal and sagital levels will be evaluated with goniometer. All groups will receive routine treatments including instructions, cervical stretching and strengthening exercises and drug (pain relief and antispasmodics).Additionally, first intervention group treats with acupuncture 3weeks/2 sessions per week and second intervention group treats with low level laser 3weeks/3 sessions per week. Third group, as a control group, only receives exercise and medication. Evaluate patients in 3 stages, i.e. before, immediately after and 2 months after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105243217N3
Registration date:2011-06-08, 1390/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-08, 1390/03/18
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
physical medicine and rehabilitation researches center,Research Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effects of acupuncture and low level laser in the treatment of myofascial neck pain syndrome,a randomized clinical trial
Public title
Comparison between effects of acupuncture and low level laser in the treatment of neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having neck pain for more than 2 months and agree to participate in the study
Exclusion criteria: Systemic; infective and tumoral diseases; radicular pain; history of fracture or surgery in the cervical spine; physiotherapy or manipulation in the last month, diagnosis of severe disc herniation in the previous MRI or EMG or severe degenerative changes in the cervical spine X ray.
Age
From 25 years old to 65 years old
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Chancellor for research, Tabriz University of Medical Sciences
Street address
Chancellor for research, 3rd floor, Central building number 2, Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz
City
Tabriz
Postal code
51656
Approval date
2011-05-17, 1390/02/27
Ethics committee reference number
1527/4/5
Health conditions studied
1
Description of health condition studied
cervical myofascial pain syndrome
ICD-10 code
M79.7
ICD-10 code description
Other soft tissue disorders, not elsewhere classified,Fibromyalgia
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, immediately after treatment and 2 months after termination of treatment
Method of measurement
Visual Analogue Scale
2
Description
Quality of life
Timepoint
Before treatment, immediately after treatment and 2 months after termination of treatment
Method of measurement
Northwick Park Questionnaire
3
Description
Cervical spine range of motion.
Timepoint
Before treatment, immediately after treatment and 2 months after termination of treatment
Method of measurement
Goniometry
4
Description
Palpation Sensitivity
Timepoint
Before treatment, immediately after treatment and 2 months after termination of treatment
Method of measurement
Examination of tender points by physician and grading 0 to 2+.
Secondary outcomes
empty
Intervention groups
1
Description
All groups recieve routine treatments including instructions, cervical stretching and strengthening exercises and drug(antiinfammatory pain relief and antispasm). Control group only treates with exercise and drug.
Category
Rehabilitation
2
Description
First intervention group :treates with acupuncture 3weeks/2 sessions per week
Category
Rehabilitation
3
Description
Second intervention group : treates with low level laser 3weeks/3 sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Leila Mohammadi
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave.Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Researches Center, Chancellor for research, Tabriz University
Full name of responsible person
Dr. Yaghoob Salek Zamani
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave.,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Researches Center, Chancellor for research, Tabriz University
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
Physical Medicine and Rehabilitation research Center, Tabriz University of Medical Sciences
Full name of responsible person
Leila mohammadi
Position
Physical Medicine and Rehabilitation Resident
Other areas of specialty/work
Street address
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave.Tabriz