Comparison of the effectiveness of the one type of Persian massage with common treatments in men with radicular low back pain,on the severity of pain, disability and quality of life
Objectives: comparison of the effectiveness of the one type of Persian massage and common treatments in men with radicular low back pain,on the severity of pain, disability and quality of life.
Design: Randomized of two parallel group.
The study population: men with radicular low back pain.
Major inclusion criteria: radicular low back pain; traverse at least 8 weeks from the onset of pain; age 25 up to 55 years; not having indication surgery; having at least a score of 3 of 10 in VAS.
Major exclusion criteria: history of surgery due to low back pain; Red flag or risk symptoms; equisetum syndrome symptoms; Lack of patient satisfaction; low back pain due to cancer.
Sample size: 30.
The study intervention: a type of Persian massage.
Intervention time: 4 weeks.
Primary outcomes: the severity of pain, disability and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052328013N1
Registration date:2017-01-06, 1395/10/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Mahdi Zarvandi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 551 2909
Email address
zarvandim921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the one type of Persian massage with common treatments in men with radicular low back pain,on the severity of pain, disability and quality of life
Public title
Comparison of the effectiveness of the one type of Persian massage with common treatments in men with radicular low back pain,on the severity of pain, disability and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: radicular low back pain(Low back pain with release to the lower extremities up to below the knee); traverse at least 8 weeks from the onset of pain (Intermittent or continuous); age 25 up to 55 years; not having of surgery indication ; having at least a score of 3 of 10 in VAS.
Exclusion criteria: history of surgery due to low back pain; the incidence of symptoms during treatment that the doctor and the therapist requires further review; Red flag or risk symptoms (such as: osteoporotic fractures, malignancies, and cauda equina syndrome, radiculitis); equisetum syndrome symptoms (numbness and weakness of both legs, perineum & anal area pain, numbness, paralysis sphangter); Lack of patient satisfaction; low back pain due to cancer or cause visceral
Age
From 25 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad, next to the Sina hospital, faculty of traditional & coplementary medicine.
City
Mashhad
Postal code
Approval date
2016-11-22, 1395/09/02
Ethics committee reference number
IR.MUMS.REC.1395.404
Health conditions studied
1
Description of health condition studied
Radicular LBP
ICD-10 code
M54.4
ICD-10 code description
Lumbago with Sciatica
Primary outcomes
1
Description
Pain
Timepoint
Three times; zero, in the first month and the third month
Method of measurement
VAS
2
Description
Disability
Timepoint
Three times; zero, in the first month and the third month
Method of measurement
Iranian form of Roland-Morris disability questionnaire
3
Description
Quality of life
Timepoint
Three times; zero, in the first month and the third month
Method of measurement
World Health Organization quality of life questionnaire (W.H.O Brief)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
intervention Group: (Iranian massage + non-surgical common treatment of low back pain)
Iranian massage style (stage1-9):
1. Hip deep rub
2. Finger pressure to the posterior thigh
3. Finger pressure to the foot and the posterior calf
4. Grab below the knee
5. Grab the calf muscles
6. depth Rub of the base of the toes
7. depth Rub of the interior floor of foot
8. Finger pressure to the sides of the knee
9. Finger pressure from the knee to the ankle
& non-surgical common treatment of low back pain, Includes; sedative and anti-inflammatory agents, exercise, heat and cold therapy, lifestyle modification.
Category
N/A
2
Description
Control Group: non-surgical common treatment of low back pain, Includes; sedative and anti-inflammatory agents, exercise, heat and cold therapy, lifestyle modification
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The center of the needle and Chinese medicine located in Imam Reza (a.s.) affiliated to the Mashhad
Full name of responsible person
Dr, Mahdi Zarvandi
Street address
Hospital Imam Reza
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr, Saiid Eslami
Street address
The Central Building of Mashhad University of Medical Sciences, University avenue
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Zarvandi
Position
Phd student of traditional Persian medicine
Other areas of specialty/work
Street address
Next to the Sina hospital, faculty of traditional & coplementary medicine.
City
Mashhad
Postal code
-
Phone
+98 51 3855 2189
Fax
-
Email
zarvandim921@mums.ac.ir; leg_med_ny@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr, Ali Khorsand
Position
Assistant professor of Chinese medicine and massage specialist
Other areas of specialty/work
Street address
Next to the Sina hospital, faculty of traditional & coplementary medicine.
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
-
Email
khorsanda@mums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences,
Full name of responsible person
Mahdi Zarvandi
Position
PhD student of traditional Persian medicine
Other areas of specialty/work
Street address
Next to the Sina hospital, faculty of traditional & coplementary medicine.
City
Mashhad
Postal code
-
Phone
+98 51 3855 2189
Fax
-
Email
zarvandim921@mums.ac.ir; leg_med_ny@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)