The effect of adding caudal neuroplasty to percutaneous laser disc decompression(PLDD) in the management of lumbar radiculopathy, a double-blind randomized clinical trial

A- General Objectives: To evaluate the effect of adding caudal neuroplasty to PLDD in controlling lumbar radiculopathy pain. B- Specific Objectives: -To determine the effect of PLDD on the pain score, ODI, Lasegue test , amount of painkillers consumption after procedure, in patients with lumbar radiculopathy. -To determine the effect of adding caudal neuroplasty to PLDD on the pain score, ODI, Lasegue test (positive or negative), amount of painkillers consumption .

Clinical trial, Parallel group, double-blind, randomized, phase II on 44 patients. Block randomization method was used for randomization.

Total of 44 patients diagnosed with lumbar radiculopathy will be included in this clinical trial. They will be divided into 2 groups of 22 patients each, and the procedures will be conducted in the prone position under local anesthesia and fluoroscopy. Group A will undergo PLDD, Group B will receive the addition of caudal neuroplasty to PLDD. The evaluator and The pain management specialist responsible for the therapeutic intervention will be blind to the grouping and the materials used.

Including criteria: Age between 30-70 years old, low back pain radiating to the lower limb for 3 months without response to maintenance treatmentDisc buldging in MRI,Informed consent Excluding criteria: Previous surgery at the same disc level,Caudaequina syndrome,Vertebral listhesis,Tumor,Infection,Vertebral fracture,Pregnancy,Severe mental and physical illness,Dissatisfaction

Group A: Lumbar disc decompression laser. Group B: Adding caudal neuroplasty to lumbar disc decompression laser.

Pain Intensity, Level of function in activities of daily living, Lasegue test, amount of painkillers consumption

Randomization: Block randomization is conducted. At the time of the first visit to the pain clinic, one of the colleagues will place the code for the first 20 patients in one envelope as Group A and the code for the next 20 patients in another envelope as Group B. This colleague will not participate in the follow-up of patients. Blinding: Another colleague of the project, who is responsible for evaluation, data collection, and follow-up, will be unaware (blind) of the method of patient group randomization. Another project colleague, responsible for the therapeutic intervention, will be unaware (blind) of the grouping or the materials used.

Blinding: Another colleague of the project, who is responsible for evaluation, data collection, and follow-up, will be unaware (blind) of the method of patient group randomization. Another project colleague, responsible for the therapeutic intervention, will be unaware (blind) of the grouping or the materials used. Patients will be unaware and blinded to the type of treatment method. They will know that they will be randomly assigned to one of the two study groups, but they will not know which treatment method will be provided in each group. Patients will be allocated to one of the two groups using a random number table. The data collector, analyst, and outcome evaluator will gather and analyze information based on Groups A and B and will remain unaware of the type of treatment in the groups, maintaining their blinding.

All data is shareable.

Access period will begin 6 months after the publication of results.

It will only be available to researchers working in academic and scientific institutions.

Any use that aids patients and advances medical science, while adhering to medical ethics, is permissible.

For obtaining the documents, contact ktynshrvni@gmail.com or visit the Pain Research Center at Rasoul Akram Hospital, located in Tehran, Sattarkhan Street, Niyayesh Street, Dr. Farnad Imani.

After submitting a clear written request and stating the purpose of data access, the data will be provided within 2 weeks upon approval.