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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2017030118754N5 |
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Date of registration:
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2017-04-22 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of laser therapy on pain of patients with cervicogenic headache.
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Scientific title:
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The effect of low level laser therapy on myofacial trigger points of cervical muscles in patients with cervicogenic headache. |
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Date of first enrolment:
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2017-04-04 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://en.irct.ir/trial/16918 |
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Study type:
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interventional |
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Study design:
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Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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1-2
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Countries of recruitment
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Afghanistan
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Contacts
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Name:
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Javad Sarrafzadeh
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Address:
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Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Mirdamad street.
15459-13487
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 2222 8051 |
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Email:
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sarrafzadeh.j@iums.ac.ir |
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Affiliation:
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School of Rehabilitation Sciences, Iran University of Medical Sciences |
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Name:
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Javad Sarrafzadeh
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Address:
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Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Mirdamad street.
15459-13487
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 2222 8051 |
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Email:
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sarrafzadeh.j@iums.ac.ir j.sarrafzadeh@gmail.com |
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Affiliation:
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School of Rehabilitation Sciences, Iran University of Medical Sciences. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: patients with cervicogenic headache (CGH) and between 18 to 40 years old; existence of minimum one trigger point in upper trapezius muscle with or without existence of trigger points in other 2 muscles of the present study; more than 10 degree limitation in cervical flexion and/or rotation to each side. Exclusion criteria: any congenital deformity; long time usage of corticosteroids or anti-inflammatory and anti-analgesic drugs; history of fracture in cervical region; herniated disc; rheumatoid arthritis; pregnancy; history of whiplash injury and neck surgery; any conservative treatment during the last 3 months before starting the present study.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
55 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Other headache syndromes
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Cevicogenic headache.
Other headache syndromes
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Intervention(s)
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Rehabilitation
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Group 1 or control group: there is no intervention and patients just use their prescription drugs.
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Group 2 or Sham group: laser probe is placed on the trigger points of the 3 muscles of the present study but the laser device is off and patients do not know that. Patients use their prescription drugs.
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Group 3 or intervention group: low level laser radiation with wavelength of 810 nm, in pulsed mode, with 11 joules intensity on trigger points of the 3 muscles of the present study.
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Intervention 1: Group 3 or intervention group: low level laser radiation with wavelength of 810 nm, in pulsed mode, with 11 joules intensity on trigger points of the 3 muscles of the present study. Intervention 2: Group 2 or Sham group: laser probe is placed on the trigger points of the 3 muscles of the present study but the laser device is off and patients do not know that. Patients use their prescription drugs. Intervention 3: Group 1 or control group: there is no intervention and patients just use their prescription drugs.
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Primary Outcome(s)
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Frequency of headache. Timepoint: Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session. Method of measurement: Number of headache during one week.
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Pain threshold. Timepoint: Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session. Method of measurement: By an algometer (algometry).
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Active cervical flexion range of motion. Timepoint: Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session. Method of measurement: CROM device.
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Quality of life. Timepoint: Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session. Method of measurement: Headache diability index (HDI) questionnaire.
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Active cervical rotation range of motion to left and right. Timepoint: Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session. Method of measurement: CROM device (degree).
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Intensity of headache. Timepoint: Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session. Method of measurement: Visual analog scale (VAS).
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Source(s) of Monetary Support
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Iran University of Medical Sciences, Vice chancellor for research
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Iran University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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