Lumbar Radiculopathy Clinical Trial
Official title:
Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy
Piriformis syndrome is a neuromuscular disorder that is characterized by piriformis muscle tenderness, hip, and leg pain, and may be accompanied by compression or irritation of the sciatic nerve under the piriformis muscle. There are many studies in the literature to establish diagnostic criteria for piriformis syndrome, and there is still no clear consensus on these criteria. However, cases with lumbar radiculopathy were accepted as exclusion criteria in all these studies. The aim of our study is to investigate whether lumbar radiculopathy and piriformis syndrome can coexist. For this reason, a diagnostic piriformis muscle injection under ultrasonography guidance is planned for patients with lumbar radiculopathy who also have a prediagnosis of piriformis syndrome clinically.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | April 15, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged over 18 years - Having clinical symptoms and signs of L4/L5/S1 radiculopathy which may be supported by imaging and/or electrodiagnostic evaluation - Having tenderness at the piriformis muscle Exclusion Criteria: - Injection history at the lumbar, hip, gluteal region in the last 6 months - Operation history at the lumbar and/ or hip region - History of inflammatory rheumatic disease - History of infectious disease - History of bleeding disorder - History of anticoagulation use - Uncontrolled diabetes mellitus or hypertension - History of neurological disease - Being in gestational or lactational period - Noncompensated chronic heart/liver/renal deficiency, or vascular/tumoral disease - Active psychiatric disease - History of allergic reaction to the substance to be applied as local anesthetic |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa |
Turkey,
Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available. — View Citation
Fishman LM, Dombi GW, Michaelsen C, Ringel S, Rozbruch J, Rosner B, Weber C. Piriformis syndrome: diagnosis, treatment, and outcome--a 10-year study. Arch Phys Med Rehabil. 2002 Mar;83(3):295-301. Review. — View Citation
Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3. — View Citation
Jankovic D, Peng P, van Zundert A. Brief review: piriformis syndrome: etiology, diagnosis, and management. Can J Anaesth. 2013 Oct;60(10):1003-12. doi: 10.1007/s12630-013-0009-5. Epub 2013 Jul 27. — View Citation
Lauder TD. Physical examination signs, clinical symptoms, and their relationship to electrodiagnostic findings and the presence of radiculopathy. Phys Med Rehabil Clin N Am. 2002 Aug;13(3):451-67. Review. — View Citation
Michel F, Decavel P, Toussirot E, Tatu L, Aleton E, Monnier G, Garbuio P, Parratte B. Piriformis muscle syndrome: diagnostic criteria and treatment of a monocentric series of 250 patients. Ann Phys Rehabil Med. 2013 Jul;56(5):371-83. doi: 10.1016/j.rehab.2013.04.003. Epub 2013 Apr 25. — View Citation
Miller TA, White KP, Ross DC. The diagnosis and management of Piriformis Syndrome: myths and facts. Can J Neurol Sci. 2012 Sep;39(5):577-83. Review. — View Citation
Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71. — View Citation
Papadopoulos EC, Khan SN. Piriformis syndrome and low back pain: a new classification and review of the literature. Orthop Clin North Am. 2004 Jan;35(1):65-71. doi: 10.1016/S0030-5898(03)00105-6. — View Citation
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Siddiq MA, Hossain MS, Uddin MM, Jahan I, Khasru MR, Haider NM, Rasker JJ. Piriformis syndrome: a case series of 31 Bangladeshi people with literature review. Eur J Orthop Surg Traumatol. 2017 Feb;27(2):193-203. doi: 10.1007/s00590-016-1853-0. Epub 2016 Sep 19. Review. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline pain at 30 minutes after piriformis muscle injection | After the piriformis muscle injection, the percentage of relief in patient's symptoms will be questioned. It has been reported that 50% or more reduction in the patient's complaints after injecting the local anesthetic agent into the piriformis muscle, with or without steroids, is diagnostic for piriformis syndrome. Therefore, patients with at least 50% reduction in post-injection complaints will be diagnosed with piriformis syndrome. | Baseline, 30 minutes after piriformis muscle injection | |
Secondary | Change in patient's pain level via Numeric Rating Scale at 1 week and 1 month after injection | Before the injection, the participants' pain at resting, sitting, standing, lying, at night, during activity will be assessed by one of the most commonly used pain scale 'numerical rating scale'. It is numeric version of 'visual analog scale' in which the patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". One week after the injection, the participant's pain while resting, walking, sitting, lying down and at night will be evaluated with a numerical rating scale and the change in pain scores will be evaluated. Similarly, the change in pain scores during the same activities one month after the injection will also be evaluated. In this way, the amount of relief that may be provided via the piriformis muscle injection in patients having lumbar radiculopathy and piriformis syndrome in short and medium terms will be evaluated. | Baseline, one week after piriformis muscle injection, one month after piriformis muscle injection |
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