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Completed

NCT Number: NCT03023969

Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain

Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, Asyut Governorate, 71111, Egypt

About this study

Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.

Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.

Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients Suffered radicular leg pain and some reported additional back pain.
  • All patients are non-responsive to conservative treatment modalities with VAS more than 7.

Exclusion criteria

  • presence of bleeding disorder
  • local infection
  • uncontrolled or degenerative spine disease
  • pregnancy
  • multilevel disk involvement
  • patient refusal.

Treatment and study plan

ozone oxygen mixture

Drug

receive 10 ml of ozone oxygen mixture under variable dosing

Primary outcomes

  1. Pain alleviation by visual analogue scale (VAS)

    Time frame: 12 months

    assessing pain alleviation by visual analogue scale (VAS)

Secondary outcomes

  1. Reduction of disk herniation by MRI

    Time frame: 6 months

    evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI

  2. Pain alleviation using Oswestry Low Back Pain Questionnaire

    Time frame: 12 months

    using Oswestry Low Back Pain Questionnaire

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2017
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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