Comparison of the Effectiveness of Epidural Injection and Acupuncture in Patients With Failed Back Surgery Syndrome

Introducing a safe, easy, cost-effective and more effective treatment method to control pain and improve quality of life in patients with FBSS (Failed Back Surgery Syndrome)

Clinical trial with control group, with parallel groups, without blinding, randomized using block method and using closed envelope tool, on 50 patients

Patients referred to the clinic of Baqiyatallah Hospital, including 2 groups of acupuncture and epidural injection, in one group ten sessions of acupuncture and in the other group three sessions of epidural corticosteroid injection are performed. Randomized clinical trial without blinding with the control group .

Patients undergoing lumbar spinal cord surgery with a diagnosis of FBSS(Failed Back Surgery Syndrome). Patients with neuropathy, plexopathy, neck radiculopathy, upper motor nerve neuron involvement and bleeding disorders and taking anticoagulants and the presence of systemic or localized fever and infection, sensitivity to epidural drugs, pregnancy and lactation, uncontrolled heart problems and diabetes excluded from the study.

1. Acupuncture ten sessions every week, two sessions and 30 minutes per session. The treatment is performed by a physical therapist. Depth of needles 1 to 1.5 cm 2. Epidural injection Three sessions of epidural corticosteroid injection once every two weeks Drugs used: triamcinolone 40 to 80 mg, bupivacaine 5% (3 to 5 cc), serum hypersaline 15 cc, hyaline 1 vial 1500

The primary outcome in this study will be pain intensity, which will be assessed using the visual analogue scale. Secondary outcomes are patients 'quality of life. Using the SF-36 quality of life questionnaire, the patients' pain assessment sections before the intervention will be one week, 1 month and three months after the intervention

This study is a randomized clinical trial using the block method. In this method, the number of people assigned to each group is usually almost equal. In this method, blocks are formed based on the considered variables and within each block, half of the intervention people and half as a control are considered. The main goal of this method is to balance the number of participants in each group. The randomization unit is individual and the patients are randomized using closed envelope tools and the patients are assigned in a ratio of 1: 1. The two groups will be examined in parallel.