Comparing the Effect of an Iranian Massage (Fateh Method) on Pain and Disability of Patients Suffering from Chronic Low Back Pain with Physiotherapy and Acupuncture
Comparing the effect of massage, physiotherapy and acupuncture on pain and disability due to chronic low back pain
Design
Clinical Trial with two intervention and one control groups, parallel groups, non-randomized, not blind, with 90 patients, enrolled between Shahrivar and Mehr 98, and followed for one month
Settings and conduct
In this study, designed as a controlled clinical trial, patients suffering from chronic low back pain more than 3 months are studied who come to Tehran University of Medical Sciences clinics in Imam Khomeyni hospital, Tooba building, Valiasr and Khark building.patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Patients are investigated in these three groups: massage, acupuncture and physiotherapy. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. Pain level and disability due to low back pain is evaluated three times in each group: before beginning therapy, after completing therapy and one month after finishing therapy. This is done by using VAS and Roland-Morris Questionnaires.
Participants/Inclusion and exclusion criteria
chronic low back pain without paresthesis and radicular pain and any specific pathology, pain more than 3 months, confirmation of low back pain and clinical examination by expert to exclude pathologies
Intervention groups
Intervention group 1:Patients undergoing massage therapy
Intervention group 2: Patients undergoing acupuncture
Control group: Patients undergoing physiotherapy
Main outcome variables
Pain and disability due to chronic low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181225042118N1
Registration date:2019-09-21, 1398/06/30
Registration timing:registered_while_recruiting
Last update:2019-09-21, 1398/06/30
Update count:0
Registration date
2019-09-21, 1398/06/30
Registrant information
Name
Parva Namiranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 3198
Email address
p-namiranian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-19, 1398/06/28
Expected recruitment end date
2019-12-19, 1398/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of an Iranian Massage (Fateh Method) on Pain and Disability of Patients Suffering from Chronic Low Back Pain with Physiotherapy and Acupuncture
Public title
Effect of Fateh Massage on Low Back Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic low back pain without paresthesis and radicular pain and any specific pathology
Pain more than 3 months
Confirmation of low back pain and clinical examination by expert to exclude pathologies
Exclusion criteria:
Pregnancy or breastfeeding
History of surgery due to low back pain
Red flags that need more investigations or surgery
Ankylosing Spondylitis
Neuropathy or neurologic problems in physical examination
Severe untreated Scoliosis
Infection in low back or spinal cord
Acute radiculopathy
Menthal problems
Acute trauma
Rheumatoid inflammatory disorders
Uncontrolled Hypertension or Diabetus Mellitus
Digestive system problems including stomach pain or ulcer, IBD
Low back pain due to Uterus conditions
Signs of weakness or Emtela
Use of Digoxin, Warfarin; Heparin
Addiction to alcohol or drugs and so on
History of epidural or transforaminal injection of anesthetics or corticosteroids during 4 weeks prior to start of treatment
Age
From 19 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Ghods street crossing Keshavarz Bld
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-12-15, 1397/09/24
Ethics committee reference number
IR.TUMS.VCR.REC.1397.667
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Loin pain, Low back strain, Lumbago NOS
Primary outcomes
1
Description
pain level due to low back pain
Timepoint
Before starting study, after the intervention, one month after intervention
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Disability level due to low back pain
Timepoint
Before starting study, after the intervention, one month after intervention
Method of measurement
Roland Morris disability questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. In this group 10 sessions of massage with the special method of Fateh -deep fascial release- is done. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully.
Category
Rehabilitation
2
Description
Intervention group 2: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Acupuncture patients receive 10 sessions of therapy each 20 minutes, twice a week. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully.
Category
Rehabilitation
3
Description
Control group: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Patients of physiotherapy group receive 10 sessions of standard physiotherapy for chronic low back pain. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Valiasr traditional medicine building
Full name of responsible person
Ahmad Fateh
Street address
no 79, next to Sahel deadend, Razi street, Valiasr junction, Hazrate Valiasr traditional medicine building
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6676 7355
Email
info@nobaan.com
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr. Seyede Zahra Emami Razavi
Street address
End of Keshavarz bld, Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
3
Recruitment center
Name of recruitment center
Tooba health building
Full name of responsible person
Dr. Mohammad Hossein Ayati
Street address
S Felestin St, Tooba health building
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6695 6749
Email
info@toobatim.ir
4
Recruitment center
Name of recruitment center
Khark traditional medicine building
Full name of responsible person
Dr. Mohammad Hossein Ayati
Street address
No 10, Khark street, Enghelab avenue
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6675 4151
Email
info@stpm.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraiyan
Street address
Central building of Tehran University of Medical Sciences, Ghods street, Keshavarz bld
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parva Namiranian
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 6, Entesariyeh st., 2nd alley, north karegar street
City
Tehran
Province
Tehran
Postal code
1413915518
Phone
+98 21 8800 3198
Fax
Email
p-namiranian@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Ayati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
North sarparast, Ahmadieh health building
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 6527
Email
mh-ayati@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parva Namiranian
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 6, Entesariyeh st., 2nd alley, north karegar street
City
Tehran
Province
Tehran
Postal code
1413915518
Phone
+98 21 8800 3198
Fax
Email
p-namiranian@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available