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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of the Presence of Piriformis Syndrome Accompanying Lumbar Radiculopathy

NCT05392933

Piriformis Syndrome Lumbar Radiculopathy

COMPLETED NA

Ultrasonographic Evaluation of the Sciatic Nerve in Patients With Piriformis Syndrome

NCT06783439

Sciatica Piriformis Muscle Syndrome

RECRUITING

The Frequency of Superior Cluneal Nerve Entrapment Diagnosed With Ultrasound Guided Nerve Block

NCT05303597

Low Back Pain Nerve Entrapment Syndrome Radiating Pain

COMPLETED NA

How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?

NCT06372691

Adult Regional Anesthesia Morbidity Anesthesia Injection Site

COMPLETED NA

Effects of Ultrasound-guided Genicular Nerve Block in Knee Osteoarthritis Patients on Proprioception and Static Balance

NCT06527651

Osteoarthritis Osteoarthritis, Knee Proprioceptive Disorders +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It was planned as a randomized controlled study. Patients diagnosed with Priformis Syndrome will be evaluated and their demographic data and examination information will be recorded.

Patients will be divided into 2 groups: ozone and lidocaine injections by computerized randomization. If there is a contraindication for ozone, the patient will be included in the lidocaine group, and similarly, if the patient has a contraindication for lidocaine, the patient will be included in the ozone group. According to G-power analysis, a total of 28 patients, 14 for each group, will be included in the study.

One group will be injected with 5 mL of lidocaine 2% after localizing the piriformis muscle with USG guidance, and the other group will be injected with 5 ml - 20 μg/mL ozone after localizing the piriformis muscle with USG guidance.

Pain levels of the patients will be evaluated with the visual analog scale at baseline, 1st Week, 1st Month and 3rd Month. Functional levels of all patients will be measured using the Lower Extremity Functional Scale; Posture evaluation includes trunk imbalance (sagittal/coronal imbalance), vertebral rotation, apical deviation, pelvic tilt, pelvic torsion, pelvic obliquity, kyphotic angle, lordotic angle measurement with DIERS 4D posture analyzer, static balance parameters with HUR balance device will be evaluated at baseline and at the 3rd month.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Piriformis Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ozone injection

After localizing the piriformis muscle with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.

Group Type ACTIVE_COMPARATOR

Ozone

Intervention Type OTHER

After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.

Lidocaine injection

After localizing the piriformis muscle with ultrasound guidance, 5 ml - 2% lidocaine will be injected.

Group Type ACTIVE_COMPARATOR

Lidocain

Intervention Type DRUG

After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 2% lidocaine will be injected.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ozone

After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.

Intervention Type OTHER

Lidocain

After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 2% lidocaine will be injected.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ozone injection Lidocaine injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No