NCT06130618

The Effects of Ultrasound Guided Ozone and Lidocaine Injections in Piriformis Syndrome

Status unknown NA Last updated 14 November 2023

What this trial tests

NA trial testing Ozone in Piriformis Syndrome in 28 participants. Status unknown.

Timeline

1 September 2023

Primary endpoint
1 March 2024

1 March 2024

Quick facts

Lead sponsor	Ankara City Hospital Bilkent
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	28
Start date	1 September 2023
Primary completion	1 March 2024
Estimated completion	1 March 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Ozone (OZONE) — full drug profile →
• Lidocain — full drug profile →

Conditions studied

• Piriformis Syndrome — all drugs for Piriformis Syndrome →

Sponsor

Ankara City Hospital Bilkent

Who can join

Adults 18 to 80, any sex, with Piriformis Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Various gases for the treatment of neuropathic pain: mechanisms, current status, and future perspectives.
   Liu Y, Shen T, Li Q, Yu X, et al · · 2025 · cited 6× · PMID 40300884 · DOI 10.4103/mgr.medgasres-d-24-00161