This study was designed with the aim of determining the effect of traditional Iranian manual techniques on the pain and disability of patients with chronic back pain.
Design
The clinical trial has a control group, with parallel, double-blind, randomized groups. The patients will be randomly divided into two groups according to the order of referral. In the intervention group, the manual technique is performed once for each person, and for the sham group, ineffective manipulation is performed at an unrelated point on the body.
Settings and conduct
Patients will be divided into two parts, treatment and placebo (blinding of the patient and the researcher), and will be subjected to the main manipulation maneuver or placebo manipulation using the table of random numbers.
Participants/Inclusion and exclusion criteria
All adults between 20 and 70 years old with chronic low back pain, provided that they have not received serious treatment or have dangerous pathology. (The list of serious treatments and dangerous pathologies are in the inclusion and exclusion criteria)
Intervention groups
Two groups: 1: intervention group (Iranian manual technique) and 2: control group (placebo (fake) manual technique)
Main outcome variables
VAS (Visual Analogue Scale) and Rowland-Morris questionnaire; the number of diclofenac tablets used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230502058050N1
Registration date:2023-05-22, 1402/03/01
Registration timing:prospective
Last update:2023-05-22, 1402/03/01
Update count:0
Registration date
2023-05-22, 1402/03/01
Registrant information
Name
Alireza Abbassian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4536
Email address
abbasian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Traditional Iranian Manual Technique on Pain and Disability in Patients with Chronic Low Back Pain
Public title
Investigating the Effect of Traditional Iranian Manual Technique on Pain and Disability in Patients with Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Personal and informed consent of the individual to participate in the research project
Presence of chronic low back pain (history of more than three months of pain)
Age range between 20 and 70 years old
Exclusion criteria:
The presence of paresthesia and radicular pain and any specific pathology such as nerve root inflammation, spinal canal stenosis, spondylolysis, spondylolisthesis, vertebral fracture (clinical examination by a neurosurgeon to rule out any pathology)
Non-mechanical back pain (wakes the patient up at night or causes pain and dryness in the morning)
Fever, sweating and unexplained weight loss in the last few months
Long-term corticosteroid therapy
The symptoms of horse tail syndrome include numbness and weakness of both legs, pain in the anus, numbness of the perineum, paralysis of the sphincters.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization with a table of random numbers to divide clients into two groups in the order of admission
Blinding (investigator's opinion)
Double blinded
Blinding description
By using a table of random numbers and inserting a random code on the paper inside the numbered envelopes, the patients are divided into two intervention and placebo groups (54 envelopes with even codes and 54 envelopes with odd codes are prepared). At the beginning of the intervention, the therapist chooses in which group (an even number or an odd number) to perform Iranian medicine manipulation and in which group to perform placebo manipulation (for example, if the code inside the envelope was an even number, the main manipulation will be performed on them, and in the case of an odd number, manipulation placebo will be done). The patient's name and surname are entered in a separate table along with the assigned code. In this way, the doctor treating the patient was not blinded, but the patient, the researcher, the author of the article, and the analyst of the results were blinded to the data.
Placebo
Used
Assignment
Parallel
Other design features
The calculated sample size in each group is 54 people, which is 60 people in each group by calculating a ten percent loss.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research School of Pharmaceutical Sciences, Tehran University of Medical Science
Street address
Poursina Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences (TIPS)
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.019
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before and immediately after the intervention and one week after the intervention
Method of measurement
VAS questionnaire
2
Description
Degree of disability
Timepoint
Before and one week after the intervention
Method of measurement
Roland Morris questionnaire
Secondary outcomes
1
Description
The number of diclofenac tablets taken
Timepoint
One week after the intervention
Method of measurement
Counting and averaging the number of pills taken daily
Intervention groups
1
Description
Intervention group: Iranian manual technique group, First, the patient lies on the examination bed in a supine position and both legs are placed together, and examinations such as: comparison of the length of the legs are performed (the distance between the two landmarks from the anterior superior iliac crest to the inner ankle in two side) and if this size is different, the person can be included in the study by considering other entry criteria. To perform the technique, the patient is placed on his side on the examination bed and the therapist holds the patient's chest and shoulder steady with one hand and puts pressure on the patient's back and pelvis with the other hand. The same technique is also performed lying on the opposite side.
Category
Treatment - Other
2
Description
Placebo group: Sham manipulation technique, In this group, the patient first lies on the examination bed in a supine position and both legs are placed together, and examinations such as: comparison of the length of the legs are performed (the distance between the two landmarks from the anterior superior iliac crest to the ankle internal on both sides) and if this size is different, the person can be included in the study considering other inclusion criteria. To perform the technique, the patient is placed on his side on the examination bed and slight pressure is applied on the iliac crest and tibia bone (bilaterally).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadiyya Clinic, Faculty of Persian Medicine, Tehran University of Medical Sciences
Full name of responsible person
Alireza Abbassian
Street address
No. 27, Sarparast Ave., Taleqani St.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Email
abbasian@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Six Floor, TUMS Building, Keshavarz Blvd., Ghods St., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://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
Alireza Abbassian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Taleghani Ave., North Sarparast St., Faculty of Persian Medicine
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4536
Fax
Email
abbasian@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Abbassian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Taleghani Ave., North Sarparast St., Faculty of Persian Medicine
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4536
Fax
Email
abbasian@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadtaghi Rezaeipour
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Taleghani Ave., North Sarparast St., Faculty of Persian Medicine
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4536
Fax
Email
ali.vafs@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about its main outcomes can be shared.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
All people
Under which criteria data/document could be used
The data can be used for scientific analysis.
From where data/document is obtainable
Our email: abbasian@sina.tums.ac.ir
What processes are involved for a request to access data/document
After viewing the resume and the reason for the request, it will be reviewed and sent within 3 months.