Clinical trial NCT06130618: The Effects of Ultrasound Guided Ozone and Lidocaine Injections in Piriformis Syndrome
Official title: The Effects of Ultrasound Guided Ozone and Lidocaine Injections on Pain, Functional Level and Posture in Piriformis Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Piriformis Syndrome
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Pain condition will evaluate by the visual analog scale
timeFrame: Baseline, 1. week, 1. month, 3. month
measure: posture
timeFrame: Baseline, 3. month
measure: Balance
timeFrame: Baseline, 3. month
Secondary outcomes:
measure: Function
timeFrame: Baseline, 3. month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Bilge Kesikburun, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.