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

NCT06130618 | Unknown

• 1 other identifier: E2-23-4633
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Piriformis Syndrome

Outcome Measures

Primary Outcomes (3)

• Pain condition will evaluate by the visual analog scale

  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

  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

  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 Outcomes (1)

• Function

  Baseline, 3. month

Study Arms (2)

Ozone injection

ACTIVE COMPARATOR

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

Other: Ozone

Lidocaine injection

ACTIVE COMPARATOR

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

Drug: Lidocain

Interventions

Ozone OTHER

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

Also known as: Ozone injection

Ozone injection

Lidocain DRUG

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

Also known as: Lidocaine injection

Lidocaine injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Jardak M, Chaari F, Bouchaala F, Fendri T, Harrabi MA, Rebai H, Sahli S. Does piriformis muscle syndrome impair postural balance? A case control study. Somatosens Mot Res. 2021 Dec;38(4):315-321. doi: 10.1080/08990220.2021.1973404. Epub 2021 Sep 14.

  PMID: 34519264 BACKGROUND

• Chon J, Kim HS, Lee JH, Yoo SD, Yun DH, Kim DH, Lee SA, Han YJ, Soh Y, Kim Y, Han YR, Won CW, Han S. Association Between Asymmetry in Knee Extension Strength and Balance in a Community-Dwelling Elderly Population: A Cross-Sectional Analysis. Ann Rehabil Med. 2018 Feb;42(1):113-119. doi: 10.5535/arm.2018.42.1.113. Epub 2018 Feb 28.

  PMID: 29560331 BACKGROUND

• Bouche K, Stevens V, Cambier D, Caemaert J, Danneels L. Comparison of postural control in unilateral stance between healthy controls and lumbar discectomy patients with and without pain. Eur Spine J. 2006 Apr;15(4):423-32. doi: 10.1007/s00586-005-1013-4. Epub 2005 Aug 18.

  PMID: 16133081 BACKGROUND

• 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.

  PMID: 25794202 BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Interventions

Ozone; Lidocaine

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bilge Kesikburun, Ass. Prof

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilge Kesikburun, Ass. Prof

CONTACT

0312 552 60 00; drbilgekb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 14, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: When the study is completed
• Access Criteria: Data will be shared in case of reasonable request.

Locations

TU (1)