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IRCT20241211064021N13 IRCT 2025-12-23 Hamedan University of Medical Sciences Investigating the effect of adding chiropractic to conventional physical modalities in the treatment of lumbar radiculopathy Studying the effect of adding traction therapy to conventional physical modalities in the treatment of lumbar radiculopathy 2026-01-21 anticipated 50 Recruiting https://irct.ir/trial/88213 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Studying the effect of adding traction therapy to conventional physical modalities in the treatment of lumbar radiculopathy. Intervention 1: 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). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: A large portion of the data is potentially shareable. When: Access to data will be available immediately after the final article is published. To whom: All researchers, researchers and clinical experts will be allowed to access the data of this study. Conditions: 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. Where to obtain: For more information, please send an email to Dr. Saeideh Kakavand. All correspondence will be sent to the email address entifad@gmail.com. How to obtain: After making a phone call and submitting a request via email, a final response will be sent within at least 1 month. Comments:
public Saideh Kakavand
Shahid Fahmedeh
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 entofad@gmail.com Hamedan University of Medical Sciences scientific Saideh Kakavand
Shahid Fahmideh St
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 entofad@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 50 years Both Active spinal fracture History of previous spinal surgery M54.16 Radiculopathy, lumbar region Rehabilitation Rehabilitation 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). 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). 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. 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). Hamedan University of Medical Sciences Approved 2025-10-25 Research Ethics Committee of Hamadan University of Medical Sciences Shahid Fahmideh St Hamadan Hamadan Iran (Islamic Republic of)