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

November 10, 2023 updated by: Bilge Kesikburun, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ozone injection
After localizing the piriformis muscle with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.
Other: Ozone
After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.
Other Names:
  • Ozone injection
Active Comparator: Lidocaine injection
After localizing the piriformis muscle with ultrasound guidance, 5 ml - 2% lidocaine will be injected.
Drug: Lidocain
After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 2% lidocaine will be injected.
Other Names:
  • Lidocaine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain condition will evaluate by the visual analog scale
Time Frame: Baseline, 1. week, 1. month, 3. month
The Visual Analog Scale (VAS) pain score (on a range of 0-10, with 0 representing no pain and 10 representing the severe pain) will evaluate.
Baseline, 1. week, 1. month, 3. month
posture
Time Frame: Baseline, 3. month
Posture Analysis will be evaluated by DIERS formetric 4D. Participants will be positioned two meters away from the camera unit and formetric 4D projection. The device will project light stripes on the back of the participant. The back's surface will be captured on camera, converted to digital data, and displayed in three dimensions. Every scan will record 12-13 images over 6 seconds (2 Hz), and the manufacturer's recommendations will be followed for processing. Spinal reference points, measures of the spinal curve, distance and localization, imbalances of the trunk and pelvis, and spinal deviation will be measured. Spine shape parameters are expressed in millimeters, percentages, or degrees depending on the specific parameter.
Baseline, 3. month
Balance
Time Frame: Baseline, 3. month
The static and dynamic postural control were measured by the HUR SmartBalance BTG4 system (Hur Labs, Tampere, Finland). Participants were asked to stand barefoot on the balance platform, and were requested to stand as quietly as possible, without moving and looking forward, during the measurement. The stable floor was the platform's own floor, while the unstable floor was the foam cushion given by the manufacturer with the device. Data were collected for 30 seconds. The following parameters were calculated from the center of pressure (CoP) displacement time series for static postural control: sway area, trace length, velocity, Romberg, lateral sway, anterior-posterior sway. The limits of stability (LOS) were used to determine the dynamic postural control. The patients were asked to tilt their bodies forward, backward, leftward, and rightward for 8 seconds in each direction.
Baseline, 3. month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function
Time Frame: Baseline, 3. month
The Lower Extremity Functional Scale (LEFS) is a set of 20 questions designed to assess an individual's capacity to carry out routine tasks. The highest possible score is 80. The lower the score means the higher the disability.
Baseline, 3. month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Bilge Kesikburun, Ass. Prof, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-23-4633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When the study is completed study protocol and Clinical Study Report will be shared.

IPD Sharing Time Frame

When the study is completed

IPD Sharing Access Criteria

Data will be shared in case of reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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