atients suffering from chronic lumbar radiculopathy, who meet inclusion criteria and have been referred to the two selected clinics, will be selected for this research but they will be removed from the study when any of the exclusion criteria applies. First clinic is traditional massage clinic and the second one is neurosurgery clinic in "Imam Khomeini's hospital". Patients of Case (treatment) group will undergo Iranian Traditional massage, while patients of Control group will be treated in classic conservative treatments way. We will select about 30 patients from each of the groups. They will fill two Standard questionnaires and will determine their pain severity according to V.A.S in first visit before treating as well as 1 month and 3 months after starting treatment. At the end, participants in each group will be classified in similar blocks of sex, age and socioeconomics specifications and results of corresponding blocks will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061810060N1
Registration date:2013-10-09, 1392/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-09, 1392/07/17
Registrant information
Name
Mamak Hashemi
Name of organization / entity
Traditional Medicine Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 8840 8319
Email address
m-hashemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Traditional Persian and Pharmacy Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of one type of Iranian Traditonal massage on lumbar radiculopathy
Public title
The effectiveness of of Iraninan traditional massage on low-back-pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lumbar radiculopathy radiating below the knee; pain lasting longer than 8 weeks (continuous or non- continuous); age between 25-55 years old; no indication for surgery or patient's disagreement or medical problem interfering surgery in case of surgery indication.
Exclusion criteria: history of low-back surgery; any suspicious sign during the treatment period requiring further evaluating or intervention; red flag signs; sign & symptoms of "Quadra Equina" syndrome (Numbness or weakness of the muscles of the lower extremeties,Anus pain, perineal or saddle anesthesia, bowel and bladder disturbances, absent lower spincture reflexes, sexual dysfunction); accelerating picture of pain in acute phase; sever or exacerbated pain picture; patient's disagreement.
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
Medical Ethics Comittee in research, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd, Qods St,
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90-04-86-13815-79684
Health conditions studied
1
Description of health condition studied
Lumbar radiculopathy
ICD-10 code
M51.1+
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 1 & 3 months after intervention initiation
Method of measurement
Visual analog scale
2
Description
Low back Pain disability
Timepoint
Before intervention, 1 & 3 months after intervention initiation
Method of measurement
Standard Rolland-Morris Questionnaire
3
Description
Quality of life
Timepoint
Before intervention, 1 & 3 months after intervention initiation
Method of measurement
W.H.O Quality of life Questionnaire (BREF)
Secondary outcomes
empty
Intervention groups
1
Description
Traditional massage explanation
The Maneuvers done in therapy sessions consist of:
• Lower limb massages (Anterior, posterior, internal & external borders); this massage is done 1 time by massager's palm in each therapy session and 5 times every day by someone else (family) at home.
- Anterior massage; in supine position massage starts from inguinal region to ankle without significant pressure on the knee
-Internal lateral massage; in supine position massage starts on internal lateral of lower limb, starts from inguinal to ankle.
-External lateral massage; in supine position massage starts on external lateral of lower limb, starts from hip to ankle.
- Posterior; in prone position lower limbs given massage from hip to ankle.
• Plantar Massage: Feet palms are massaged by a cylinder shape instrument or wood rolling pin.
• Lumbar massage (7 parts)
1- Lumbar region is massaged several minutes using almond oil for relaxing muscles and fascias.
2- Cross massage; patient lays in supine position crosses one lower limb over the other, fixing his or her body grasping bed sides. The massager massages the above limb which is stretched from proximal to distal regarding same general conditions.
3- knee-chest (prostrate) or fetus position massage; patient is given massage in knee-chest (prostrate) position. If this position is difficult he/she may lie on the side folding lower limbs like fetus position, instead.
4- Stretching upward (in case of severe lumbar stiffness); Patient lies in supine position, someone raises lower limbs one to one to separate lumbar region from bed then the massager massages stretched back.
5- Massage paraverterbral muscles; patient's paravertebral muscles are given massage in prone position by massager's thumb (circulating pressure by thumb) from neck to end of spine several times.
6- Skin pinch; different parts of back skin and subcutaneous tissue are pressed between 1th and 2nd fingers of both massager's hand and pulled out in prone position to recover skin and fascia elasticity. Cupping is a replacement for this maneuver.
7- Kneading back muscles & stretch; Patient lies in prone extending his/her upper limbs fixing body by grasping bed top, someone pulls the lower limbs. The massager massages his/her back and lower limbs in stretched position.
• Trigger points release; tender points found in massage process are being pressed to release.
• Cupping; cupping with several size cups is done to improve blood circulation if signs and symptoms of poor circulation are present.
• Dressing; after massage session and rubbing oil, patient's back is dressed and wrapped by cotton cloth (30 cm * 400 cm).
• Abdomen massage; since constipation delays low back pain recovery, abdomen is massaged by massager's palm clockwise to help stool movement.
*All massages done by massager's hand, apply pressure about 1 kg force.
Category
Rehabilitation
2
Description
Control group: standard medical treatment for lumbar radiculopathy by neurosurgeon.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heravi Traditional Medicine clinic
Full name of responsible person
Kamran Mahlooji Kermanshahi
Street address
West jamali, Heravi SQ
City
Tehran
2
Recruitment center
Name of recruitment center
Neurosurgery Clinic. Imama khomeini hospital
Full name of responsible person
Mamak Hashemi
Street address
Imama Khomeini hospital, Keshavarz boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Science
Full name of responsible person
Bagher Minaie Ph.D
Street address
Behesht ST. Vahdat eslami ST. Hafez Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine (RICM), Iran University of Medical Science
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Akbari
Street address
4th floor, Central organiztion of Tehran University of medical sciences, Ghods ST corner, Keshavarz Boulevard
City
Tehran
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
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
Traditional Medicine Faculty, Tehran University of Medical sciences
Full name of responsible person
Mamak Hashemi Habibabadi
Position
General practitioner, Traditional Medicine Resident
Other areas of specialty/work
Street address
Behesht St, Vahdat Islami St, Hafez Ave
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
+98 21 8840 8319
Email
m-hashemi@tums.ac.ir; mamak.hashemi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Traditional medicine faculty, Tehran university of medical sciences.
Full name of responsible person
Mamak Hashemi Habibabadi
Position
General practitioner, Traditional Medicine Resident
Other areas of specialty/work
Street address
Behesht St, Vahdat Islami St, Hafez Ave
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
+98 21 8844 2285
Email
m-hashemi@razi.tums.ac.irmamak78@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine faculty, Tehran University of medical sciences
Full name of responsible person
Mamak Hashemi Habibabadi
Position
General practitioner, Traditional Medicine Resident
Other areas of specialty/work
Street address
Behesht St, Vahdat Islami St, Hafez Ave
City
Tehran
Postal code
Phone
+98 21 5561 3191
Fax
+98 21 8844 2285
Email
m-hashemi@razi.tums.ac.irmamk78@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)