Assessing the impact of a traditional medicine-derived manipulation technique (Ghamz therapy) on pain intensity and disability in patients suffering from chronic back pain extending to the lower limbs.
Design
This study is a single-arm, open-label, non-randomized clinical trial focusing on patients with chronic low back pain that radiates to the lower limbs. It includes 15 participants.
Settings and conduct
Patients suffering from chronic back pain with lower extremity referral who visit the Faculty of Traditional Medicine at Shahid Beheshti University of Medical Sciences during the 2024-2025 period will be included in the study, provided they meet the established inclusion criteria
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic back pain lasting more than 8 weeks, radiating to the lower limbs, who have a pain intensity of 3 or greater on the visual analog scale (VAS). Exclusion Criteria for Participation in the Study:
Having surgical indications
Intervention groups
A group includes patients with chronic low back pain that spreads to the lower limbs, who are included in the study based on the inclusion criteria. The intervention involves the use of a manual technique rooted in traditional medicine known as "Ghamz therapy". This method includes applying pressure to specific points in the lower back and lower limbs using a specialized wooden tool, which facilitates the release of myofascial spasms. The intervention consists of three sessions scheduled on day 0, day 7, and day 37 for all patients.
Main outcome variables
Pain intensity assessed using the Visual Analog Scale (VAS);
Patient disability level measured using the Roland-Morris Disability Questionnaire score; Back flexibility determined through the Fingertips-to-Floor test;Patients' quality of life evaluated using the World Health Organization Quality of Life Questionnaire (Short Form-WHOQOL).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190112042333N2
Registration date:2024-10-01, 1403/07/10
Registration timing:registered_while_recruiting
Last update:2024-10-01, 1403/07/10
Update count:0
Registration date
2024-10-01, 1403/07/10
Registrant information
Name
Sajjad Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
drsadeghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-30, 1403/07/09
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of manipulation derived from traditional medicine on low back pain spread to the lower limbs
Public title
Effect of manipulation derived from traditional medicine on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain radiating to the one-sided lower limb
Completion of the informed consent process to participate in the study
Onset of pain at least 8 weeks ago (constant or intermittent)
BMI between 18-35
Pain intensity VAS score ≥ 3
Exclusion criteria:
Malignancy
Pregnancy
Symptoms of Cauda equina syndrome include numbness and weakness of both legs, pain spread to the anus, numbness of the perineum, paralysis of the sphincters.
History of rheumatic diseases
Presence of paresthesia and specific pathology including spondylolysis, spondylolisthesis, vertebral fracture
Suffering from all types of myopathies
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-08-18, 1403/05/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.265
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
Pain intensity
Timepoint
Before the start of the intervention, one week after the intervention and 37 days after the start of the intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Quality of life
Timepoint
Before the start of the study and 37 days after the start of the study
Method of measurement
WHO quality of life questioner (Short Form-WHOQOL)
3
Description
Diability
Timepoint
Before the start of the study and 37 days after the start of the study
Method of measurement
Roland-Morris disability questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administering a technique from Traditional Medicine known as "Ghamz therapy", which involves applying pressure with a specially designed wooden tool to targeted areas of the patient's back and lower limbs. This treatment consists of three sessions: one at the beginning of the visit, another one week later, and a final session 37 days after the intervention begins
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Traditional Medicine, Shahd Beheshti University of Medical Sceinces
Full name of responsible person
Sajjad Sadeghi
Street address
School of Traditional Medicine Shahid Beheshti University of Medical Sciences No.8 Shams Alley, Vali-e-Asr Street Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6028
Email
itm.beheshti@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
5th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sajjad Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine Shahid Beheshti University of Medical Sciences No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6021
Email
drsadeghi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sajjad Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine Shahid Beheshti University of Medical Sciences No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6021
Email
drsadeghi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sajjad Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine Shahid Beheshti University of Medical Sciences No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6021
Email
drsadeghi@sbmu.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcomes of the study
When the data will become available and for how long
6 months after the publication of the research paper
To whom data/document is available
Faculty members of universities
Under which criteria data/document could be used
With the aim of modeling to conduct a similar study
Save translation
From where data/document is obtainable
Email of the chief researcher to the following address:
Drsadeghi@sbmu.ac.ir
What processes are involved for a request to access data/document
Submission of the request via email, obtaining approval from the center's research council, and then receiving the requested information.