Protocol summary

Study aim
Evaluation of an Iranian Traditional Medicine Based Manipulation (Hasanzadeh Technique) on Clinical Symptoms and Quality of Life of Patients Chronic Radicular Low Back Pain compared to Physiotherapy
Design
70 patients with chronic radicular back pain who meet the inclusion criteria according to examination and paraclinical data will be enrolled in the study and randomly divided into two groups; one group will receive 10 consecutive one-hour physiotherapy sessions three times a week, and the second group will receive 3 sessions of Ghamz according to the Hassanzadeh method on the first day, day 8, and day 38.
Settings and conduct
Data collection will be conducted at Shahid Beheshti College of Traditional Iranian Medicine and Baqiyatullah Al-Azam Hospital. There is no possibility of blinding the study, so the data analyst will be blinded and efforts will be made to avoid providing biased explanations and any attempt to change the attitude of the study patients.
Participants/Inclusion and exclusion criteria
Back pain radiating to the lower extremities unilaterally Completed an informed consent form for study entry Pain onset at least 8 weeks ago (continuous or intermittent) Age between 18-60 years BMI between 18-35 Pain intensity VAS score ≥ 3
Intervention groups
70 patients with chronic radicular back pain who meet the inclusion criteria according to examination and paraclinical data will be enrolled in the study and randomly divided into two groups; one group will receive 10 consecutive one-hour physiotherapy sessions three times a week, and the second group will receive 3 sessions of Ghamz according to the Hassanzadeh method on the first day, day 8, and day 38.
Main outcome variables
Visual analogue scale (VAS) pain score in the lower extremities; disability; quality of life; age; education; gender; weight; Fingertips to Floor (F2F) test; analgesic use; satisfaction with treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250205064650N1
Registration date: 2025-03-13, 1403/12/23
Registration timing: registered_while_recruiting

Last update: 2025-03-13, 1403/12/23
Update count: 0
Registration date
2025-03-13, 1403/12/23
Registrant information
Name
Bahman Rokhafrooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
rokhafruz.bahman@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of an Iranian Traditional Medicine Based Manipulation (Hasanzadeh Technique) on Clinical Symptoms and Quality of Life of Patients Chronic Radicular Low Back Pain compared to Physiotherapy.
Public title
The effect of manipulation derived from traditional medicine on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unilaterally radicular low back pain Completed informed consent to enter the study Pain onset at least 8 weeks ago (continuous or intermittent) Age between 18-60 years Pain severity VAS score ≥ 3
Exclusion criteria:
Previous surgical history or RCLBP Presence of paresthesia and specific pathology including spondylolysis, spondylolisthesis, vertebral fracture Having muscle wasting and weakness of the lower limbs• Having various myopathies Fever, sweating and unexplained weight loss in the last few months Long-term corticosteroid therapy Symptoms of cauda equina syndrome including numbness and weakness of both legs, pain radiating to the anus, perineal numbness, sphincter paralysis Having malignancy Having an indication for emergency surgery with criteria including acute onset of motor deficit, perineal numbness, and bladder and bowel dysfunction in cauda equina syndrome Severe osteoporosis according to history if there is a bone density scan T-score less than -2.5 Vascular problems of the lower extremities Diabetes: Given that in this study, neuromuscular examination is not performed and there is no estimate of nerve involvement, diabetic patients were excluded from this study History of hip fracture and dislocation Known psychological disorders based on the patient's history including major depression, severe anxiety, psychosis, schizophrenia, bipolar disorder, and personality disorder History of surgery and muscle and fascial tears in the lower extremities Patients treated with blood thinners including warfarin and heparin History of use of injectable opioids History of rheumatic diseases
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: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign patients to two treatment groups, the Blocked Randomization method with blocks of four will be used. First, six possible states of blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed and a number from one to six is assigned to each block. Then, numbers between one and six are randomly selected using a table of random numbers, and then people are assigned to the Manipulation (A) and Physiotherapy (B) group based on the block corresponding to the selected number, and this work is done until completion. The sample size will continue.
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 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
2025-01-12, 1403/10/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.695

Health conditions studied

1

Description of health condition studied
Radicular 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 and 38 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 38 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 38 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

2

Description
Control group: Patients in the physiotherapy group will receive 10 consecutive one-hour physiotherapy sessions three times a week. Each session will include hot pack therapy (heat at 71-74°C for 20 minutes), transcutaneous electrical nerve stimulation (TENS; at a frequency of 100 Hz for a total of 20 minutes, intensity adjusted according to patient tolerance), and ultrasound (1 MHz, 1.5 W/cm2 for a total of 10 minutes) applied to the lumbar region.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti School of Traditional Iranian Medicine
Full name of responsible person
Bahman Rokhafrooz
Street address
Department of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Shams Alley, Vali Asr ave, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sitm@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Baqieh ollah alazam hospital
Full name of responsible person
Bahman Rokhafrooz
Street address
Baqieh ollah alazam hospital, Molla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 21 8126 7112
Email
bag@bmsu.ac.ir

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
1985717443
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
Bahman Rokhafrooz
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Department of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Shams Alley, Vali Asr ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
rokhafruz.bahman@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahman Rokhafrooz
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Department of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Shams Alley, Vali Asr ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
rokhafruz.bahman@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahman Rokhafrooz
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Department of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Shams Alley, Vali Asr ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
rokhafruz.bahman@gmail.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
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: Rokhafruz.bahman@gmail.com
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.
Comments
Loading...