Investigation the effect of low frequency electrical stimulation on neck trigger points
Design
This study is a double blind clinical trial with parallel groups and a control group which will be conducted on 60 patients with neck pain complaints. The inclusion criteria are 18 to 65 years of age and complaints of pain in the neck area and having painful points and palpable bands. Patients will be divided into 3 groups by block randomization using sealed envelopes. First group receives 5 sessions TENS with 2 to 10 Hz frequency and 200 to 250 microsecond pulse duration in addition to specific exercises. Second group receives 5 sessions TENS with 120 Hz frequency and 80 to 100 microsecond pulse duration in addition to specific exercises. Control group receives 5 sessions placebo TENS (on device without output) in addition to specific exercises.
Outcome measures will be measured before the treatment, after 5 sessions and after 3 months.
Settings and conduct
This study will be conducted at Firoozgar Hospital in Tehran. The study population is the patients referred to the specialized clinic of physical medicine and rehabilitation with neck pain complaints. Then, patients will be randomly assigned into 3 groups by block randomization using sealed envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Complications of neck pain and painful points and palpable bands
Exclusion Criteria:
1. Obvious mental illness
2. Cervical Radiculopathy
3. Joint degenerative disease
4. Systemic diseases
5. History of surgery in the neck
6. History of fracture in the neck
7. pregnancy
Intervention groups
First group receives TENS with 2 to 10 Hz frequency and 200 to 250 microsecond pulse duration in addition to specific exercises.
Second group receives TENS with 120 Hz frequency and 80 to100 microsecond pulse duration in addition to specific exercises.
Control group receives placebo TENS (on device without output) in addition to specific exercises.
Main outcome variables
1. Pain
2. Performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150219021139N12
Registration date:2018-04-15, 1397/01/26
Registration timing:registered_while_recruiting
Last update:2018-04-15, 1397/01/26
Update count:1
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Safoora Ebadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 175 7107
Email address
ebadi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-15, 1396/08/24
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupuncture like TENS in the Treatment of cervical Myofascial trigger points
Public title
The Effect of TENS on neck trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complications of neck pain and having painful points and palpable bands in neck
Exclusion criteria:
Obvious mental illness
Neck radiculopathy
Joint degenerative disease
Systemic diseases
History of surgery in the neck
History of fracture in the neck
pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization using sealed envelopes into 3 groups
Blinding (investigator's opinion)
Double blinded
Blinding description
1- Participants Do not know which kind of TENS they are receiving.
2- Since the TENS apparatus will be applied by the physical therapist assistant, and the monitor of the device would not be in either patient's or therapist's sight, the therapist is blind to the allocation.
3- The outcome assessor who is the main investigator, would not be aware of the allocation when assessing the patients in the measuring time points.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran university of medical sciences
Street address
Iran University of Medical Sciences,Shahid Hemmat Highway.Tehran,1449614535,IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511524007
Health conditions studied
1
Description of health condition studied
myofascial pain
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
pain
Timepoint
Before treatment, after treatment, after three months from the end of treatment
Method of measurement
Visual Scale of Pain
2
Description
function
Timepoint
Before treatment, after treatment, after three months from the end of treatment
Method of measurement
Shortness-disability questionnaire for arm, shoulder and hand and cervical problem questionnaire
Secondary outcomes
1
Description
Cervical range of motion
Timepoint
Before treatment, after the end of treatment, after three months of the end of treatment
Method of measurement
Universal Goniometer
2
Description
Pressure pain threshold
Timepoint
Before treatment, after the end of treatment, after three months of the end of treatment
Method of measurement
Algometer
Intervention groups
1
Description
First group receives TENS with 2-10 Hz frequency and 200-250 microsecond pulse duration in addition to specific exercises.
Category
Rehabilitation
2
Description
Second group receives TENS with 120 Hz frequency and 80 - 100 microsecond pulse duration in addition to specific exercises.
Category
Rehabilitation
3
Description
Control group: Control group receives placebo TENS (on device without output) in addition to specific exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr. Safara Ebadi
Street address
Physical Medicine and Rehabilitation Department,Firouzgar Hospital,Behafarin St.,Karim Khane zand St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8214 1229
Email
ebadi.s@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr,javad Ali Musavi
Street address
Iran University of Medical Sciences,Shahid Hemmat Highway.Tehran,1449614535,IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5503
Email
ebadi.s@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Safora Ebadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physical Medicine and Rehabilitation Department,Firouzgar Hospital,Behafarin St.,Karim Khane Zand St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Safora Ebadi
Position
Assistant professor,PhD Pt
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physical Medicine and Rehabilitation Department,Firouzgar Hospital,Behafarin St.,Karim Khane Zand St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iumc.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Safora Ebadi
Position
Assistant professor,PhD Pt
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physical Medicine and Rehabilitation Department,Firouzgar Hospital,Behafarin St.,Karim Khane zand St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set can be shared
When the data will become available and for how long
starting after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
in case other researchers want to perform additional analysis on the data other than published their application will be discussed in an authors meeting.
From where data/document is obtainable
via investigator's email
ebadi.s@iums.ac.ir
What processes are involved for a request to access data/document
applicant should email his/her identification specifications and the reason she is applying.