Clinical trial

The Effects of Ultrasound Guided Ozone and Lidocaine Injections on Pain, Functional Level and Posture in Piriformis Syndrome

Name
E2-23-4633
Description
Piriformis Syndrome (PS) is defined as a trap neuropathy that involves compression of the sciatic nerve by the piriformis muscle, leading to a number of symptoms along with sciatic pain, initially in the hip muscles. In clinical practice, it is estimated to be between 12.2-27%. Repetitive movements with increased demand on the piriformis muscle can lead to increased muscle tension, compression of the sciatic nerve within the muscle, and the development of PS. Additionally, the anatomical structure of the piriformis muscle and the alignment and damage of adjacent structures play a role in the pathophysiology of sciatic nerve compression in PS. It is considered in pathophysiology that a morphological change (contracture, hypertrophy) may cause compression of the sciatic nerve or the relationships of different anatomical structures that change with biomechanical restrictions. Pain is observed along the ipsilateral sciatic nerve distribution due to compression of the sciatic nerve. Additionally, it has been observed that patients with PS are accompanied by weakness in the gluteal muscles, mostly in the gluteus maximus and medius muscles. Accompanying weakness has an effect on static and dynamic posture (2,3). The negative effect of pain on posture has also been shown in studies (4). Pain and muscle changes in the lower extremities also cause disability and postural instability. It has been reported that static and dynamic postural balance is reduced in PS compared to healthy controls (1). Conservative treatment for PS significantly reduces pain with a wide range of therapeutic alternatives. Since ozone injection does not have side effects or major complications, its use in the treatment of myofascial pain syndromes and piriformis syndrome is supported by studies (5). It has an analgesic effect, increasing the pain threshold by activating serotonin-mediated pathways to release endogenous opioids. Additionally, it is used safely due to its low side effect profile. In the literature, it has been shown that local anesthetic injection applications alone or in combination with steroids are effective in the treatment of PS alone due to the therapeutic effects of local anesthetic (6). This study aimed to investigate the effects of ozone and local anesthetic injection on pain, functional level and posture in patients diagnosed with PS.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-03-01
Trial end
2024-03-01
Status
Recruiting
Treatment
Ozone
After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.
Arms:
Ozone injection
Other names:
Ozone injection
Lidocain
After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 2% lidocaine will be injected.
Arms:
Lidocaine injection
Other names:
Lidocaine injection
Size
28
Primary endpoint
Pain condition will evaluate by the visual analog scale
Baseline, 1. week, 1. month, 3. month
posture
Baseline, 3. month
Balance
Baseline, 3. month
Eligibility criteria
Inclusion Criteria: * Patients over 18 years of age * Patients with pain in the posterior aspect of the thigh and diagnosed with piriformis through physical examination and special tests * Knowing how to read and write Turkish * Patients with visual analog scale ≥5 Exclusion Criteria: * Those with a history of lumbar discopathy or a history of discopathy surgery * BMI over ≥ 30 * Having had a corticosteroid injection within the last 3 months * Presence of neurological deficit in the lower extremity * Having a history of previous hip surgery * Having progressive or non-progressive central and peripheral nervous system disease, * Patients in pregnancy and lactation * Use of anticoagulants
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}
Updated at
2023-11-14

1 organization

1 product

1 indication

Product
Lidocain