Protocol summary
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Study aim
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Investigation the effect of low-frequency electrical stimulation on neck trigger points
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Design
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This study is a double-blind, single-center clinical trial with parallel groups and a control group that will be conducted on 60 patients with neck pain complaints. Patients will be divided into 3 groups by block randomization using sealed envelopes. Outcome measures will be measured before the treatment, after 5 sessions, and after 3 months.
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Settings and conduct
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This study will be conducted at Firoozgar Hospital in Tehran in patients referred to physical medicine and rehabilitation clinic with neck pain complaints. Then, patients will be randomly assigned into 3 groups by block randomization using sealed envelopes. Participants do not know what type of Transcutaneous electrical nerve stimulation (TENS)is being used for them. since the TENS device is administered by a physiotherapist and the screen will not be visible to the patient or physician, the physician will be blind to grouping. The outcome assessor, who is the lead researcher, will be blind to the grouping when evaluating outcomes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Complications of neck pain and painful points and palpable bands.
Exclusion Criteria: Obvious mental illness, Cervical Radiculopathy, Joint degenerative disease, Systemic diseases, History of surgery in the neck, History of fracture in the neck, pregnancy.
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Intervention groups
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First group receives Transcutaneous electrical nerve stimulation (TENS) with 2-10 Hz frequency and 200-250 microsecond (ms) pulse (PD) in addition to specific exercises.
Second group receives TENS with 120 Hz frequency and 80-100 ms PD duration in addition to specific exercises.
Control group receives placebo TENS in addition to specific exercises.
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Main outcome variables
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Pain, Performance
General information
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Reason for update
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Study scheduling update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150219021139N12
Registration date:
2018-04-15, 1397/01/26
Registration timing:
prospective
Last update:
2020-06-12, 1399/03/23
Update count:
1
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Registration date
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2018-04-15, 1397/01/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-16, 1397/01/27
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Expected recruitment end date
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2019-04-16, 1398/01/27
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Actual recruitment start date
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2018-04-16, 1397/01/27
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Actual recruitment end date
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2019-04-16, 1398/01/27
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Trial completion date
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2019-08-15, 1398/05/24
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Scientific title
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The Effect of Acupuncture like TENS in the Treatment of cervical Myofascial trigger points
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Public title
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The Effect of TENS on neck trigger points
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block Randomization using sealed envelopes into 3 groups
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-11-03, 1396/08/12
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Ethics committee reference number
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IR.IUMS.FMD.REC 1396.9511524007
Health conditions studied
1
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Description of health condition studied
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myofascial pain
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ICD-10 code
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M79.1
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ICD-10 code description
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Myalgia
Primary outcomes
1
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Description
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pain
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Timepoint
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Before treatment, after treatment, after three months from the end of treatment
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Method of measurement
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Visual Scale of Pain
2
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Description
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function
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Timepoint
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Before treatment, after treatment, after three months from the end of treatment
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Method of measurement
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Shortness-disability questionnaire for arm, shoulder and hand and cervical problem questionnaire
Secondary outcomes
1
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Description
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Cervical range of motion
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Timepoint
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Before treatment, after the end of treatment, after three months of the end of treatment
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Method of measurement
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Universal Goniometer
2
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Description
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Pressure pain threshold
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Timepoint
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Before treatment, after the end of treatment, after three months of the end of treatment
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Method of measurement
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Algometer
Intervention groups
1
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Description
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First group receives TENS with 2-10 Hz frequency and 200-250 microsecond pulse duration in addition to specific exercises.
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Category
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Rehabilitation
2
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Description
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Second group receives TENS with 120 Hz frequency and 80 - 100 microsecond pulse duration in addition to specific exercises.
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Category
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Rehabilitation
3
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Description
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Control group: Control group receives placebo TENS (on device without output) in addition to specific exercises.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Deidentified Individual Participant Data Set can be shared
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When the data will become available and for how long
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starting after publication
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To whom data/document is available
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people working in academic institutions
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Under which criteria data/document could be used
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in case other researchers want to perform additional analysis on the data other than published their application will be discussed in an authors meeting.
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From where data/document is obtainable
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via investigator's email
ebadi.s@iums.ac.ir
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What processes are involved for a request to access data/document
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applicant should email his/her identification specifications and the reason she is applying.
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Comments
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