Protocol summary

Study aim
Investigating the effect of adding teletherapy to conventional physiotherapy treatments on improving pain, reducing functional disability, and increasing active range of motion in patients with lumbar radiculopathy
Design
A controlled, double-blind, randomized, phase 3 clinical trial with a parallel group on 50 patients, randomized using a randomized permutation block design.
Settings and conduct
The study is conducted at the Mobasher Physical Medicine and Rehabilitation Clinic of Hamadan University of Medical Sciences. Individuals with lumbar radiculopathy, after meeting the conditions and inclusion and exclusion criteria of the study, are invited to voluntarily participate in the research project. After consenting to participate in the study, the personal characteristics form and inclusion and exclusion criteria and demographic questionnaire including age, gender, occupation, symptoms, clinical examinations, and medical history of the individual are completed by the examiner and divided into two experimental and control groups using randomized permutation blocks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with unilateral lumbar radiculopathy based on clinical examination and MRI_Onset of symptoms more than one month before study entry. Exclusion criteria: Active spinal fracture_ History of previous spinal surgery
Intervention groups
Intervention group: Routine physiotherapy treatment (TENS + McKenzie and stabilizing exercises) + teletherapy (Tecar 560G device, 10 sessions, 20 minutes per session including 10 minutes of capacitance at 600 kHz and 10 minutes of resistance at 450 kHz) Control group: Only routine physiotherapy treatment similar to the intervention group, without teletherapy
Main outcome variables
Severity of low back and lower limb pain_Low back disability index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241211064021N13
Registration date: 2025-12-23, 1404/10/02
Registration timing: prospective

Last update: 2025-12-23, 1404/10/02
Update count: 0
Registration date
2025-12-23, 1404/10/02
Registrant information
Name
Faeze Noori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 4033
Email address
ethics@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of adding traction therapy to conventional physical modalities in the treatment of lumbar radiculopathy
Public title
Investigating the effect of adding chiropractic to conventional physical modalities in the treatment of lumbar radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral lumbar radiculopathy based on clinical examination and MRI Age between 20 and 50 years Written informed consent to participate in the study Onset of symptoms more than one month before study entry
Exclusion criteria:
Active spinal fracture History of previous spinal surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used to implement random assignment. In this way, 30 consecutive numbers (from 1 to 30) will be written separately on paper and placed in a container. Then, each participant in the experiment will be asked to randomly select one of these 50 numbers from the container containing the numbers. People who chose numbers 1 to 25 will be assigned to group A ("Intervention Group 1"), people who chose numbers 26 to 50 will be assigned to group B ("Intervention Group 2").
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is conducted in a double-blind manner. To reduce bias in the study, the main researcher as the evaluator will not divide the samples into two groups, so he will not be aware of the grouping of the individuals, and the grouping of the samples and the intervention will be done by the physiotherapist, and the information obtained from the data will be provided to the statistical evaluator in a coded and non-identifiable form. Therefore, this study is a double-blind type.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2025-10-25, 1404/08/03
Ethics committee reference number
IR.UMSHA.REC.1404.656

Health conditions studied

1

Description of health condition studied
Studying the effect of adding traction therapy to conventional physical modalities in the treatment of lumbar radiculopathy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region

Primary outcomes

1

Description
Severity of back and lower limb pain
Timepoint
At the beginning of the study (Baseline) _ After the tenth treatment session (End of treatment) _ Three months after the end of treatment (Follow-up)
Method of measurement
With a numerical pain rating scale (NRS or Numeric Rating Scale: 0–10); the patient reports the intensity of pain at rest and during activity.

Secondary outcomes

1

Description
Lumbar Disability Index
Timepoint
At the beginning of the study, at the end of the tenth session, and three months after the end of treatment
Method of measurement
Valid Persian version of the ODI questionnaire (10 questions, score 0–50; converted to percentage of disability)

Intervention groups

1

Description
Intervention group: Técar Therapy + conventional physiotherapy. In addition to receiving a standard conventional physiotherapy program (including specific exercises), patients in this group will receive one Técar Therapy session at a specified time interval (e.g., five times a week for two weeks).
Category
Rehabilitation

2

Description
Control group: Usual Physiotherapy. Description: Patients in this group only received the standard usual physiotherapy program prescribed for the treatment of lumbar radiculopathy. The usual physiotherapy treatment included 10 sessions of TENS plus exercise therapy, which was used in no particular order in each treatment session for 35 minutes (20 minutes of low-frequency TENS, with a frequency of 5 Hz and a pulse duration of 300 microseconds and the use of IR for 15 minutes on the lumbar region), exercise therapy including McKenzie exercises and lumbopelvic stabilization exercises (bridge, quadrupeds, and cross-leg raises).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Mobasher Kashani Physical Medicine and Rehabilitation Clinic, Hamadan University of Medical Sciences
Full name of responsible person
Saideh Kakavand
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
65178338678
Phone
+98 81 3131 0000
Email
enfodak@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
enfodak@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Saideh Kakavand
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Fahmedeh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
entofad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saideh Kakavand
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
entofad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saideh Kakavand
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
entofad@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
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
A large portion of the data is potentially shareable.
When the data will become available and for how long
Access to data will be available immediately after the final article is published.
To whom data/document is available
All researchers, researchers and clinical experts will be allowed to access the data of this study.
Under which criteria data/document could be used
It will be welcomed to conduct extensive analysis on the data of this study along with the data of other studies to write meta-analysis review articles.
From where data/document is obtainable
For more information, please send an email to Dr. Saeideh Kakavand. All correspondence will be sent to the email address entifad@gmail.com.
What processes are involved for a request to access data/document
After making a phone call and submitting a request via email, a final response will be sent within at least 1 month.
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