Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201908620943471 Date of Approval: 07/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Medical Ozone for Treatment of Chronic Musculoskeletal Pain with Abnormal Mitochondrial Redox State
Official scientific title Efficacy of Medical Ozone for Treatment of Chronic Musculoskeletal Pain with Abnormal Mitochondrial Redox State
Brief summary describing the background and objectives of the trial Muscle pain is thought to occur by two main mechanisms: peripheral and central. Peripheral factors include trauma, dysregulated microcirculation, altered muscular metabolism, and mitochondrial function. Mitochondrial content determines the aerobic capacity of a muscle and is impaired in chronic musculoskeletal pain leading to decrease of adenosine triphosphate (ATP) that in turn propagates contracture and the resulting compressed capillary circulation can cause a hypoxic environment. The majority of confirmed mitochondrial oxidative defects present with a raised blood lactate and this is often associated with elevated lactate/pyruvate ratio, which means a change in the cellular redox state. Trigger points (TPs) are loci of hypersensitivity within a tender, taut, palpable band of muscle. Ozone therapy causes an increase in the red blood cell glycolysis rate, stimulates the 2,3-diphosphoglycerate increasing amount of O₂ released to the tissues, activates the Krebs cycle by enhancing oxidative carboxylation of pyruvate, stimulating the production of ATP. It causes a significant reduction in NADH and helps to oxidize cytochrome C. It induces production of enzymes that act as free radical scavengers and cell-wall protectors: glutathione peroxidase, catalase, and superoxide dismutase. Production of prostacyclin, a vasodilator, is also induced by O3. by the above mechanisms, Ozone therapy can improve tissue oxygenation, oxidation and reduces NADH and lactate production so it may improve pain. While Steroids have anti-inflammatory action by limiting capillary dilatation and permeability that restrict polymorphs and macrophages accumulation and inhibit the release of vasoactive kinins. The aim of this work is to study the efficacy of trigger point injection with medical ozone for the treatment of chronic musculoskeletal pain in patients with abnormal mitochondrial Redox state compared to standard steroid injection or combination therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date 29/02/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ozone a trigger point injection of 5 ml of 12 mic/ml ozone Once intraoperative in the operative theatre a trigger point injection of 5 ml of 12 mic/ml ozone using EXT50 ozone generator (Longevity resources, Canada) for each point. 15
Experimental Group Ozone and steroid a trigger point injection of 5 ml of 12 mic/ml ozone and 0.5 mg betamethasone injectable suspension diluted in 2 ml sterile water Once intraoperative in the operative theater a trigger point injection of 5 ml of 12 mic/ml ozone and 0.5 mg betamethasone injectable suspension diluted in 2 ml sterile water 15
Control Group steroid a trigger point injection 0.5 mg betamethasone injectable suspension diluted in 2 ml sterile water Once intraoperative in the operative threater a trigger point injection 0.5 mg betamethasone injectable suspension diluted in 2 ml sterile water 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with chronic musculoskeletal pain for more than 6 months. Patients with 4 – 8 trigger points VAS more than 4. Serum lactate/pyruvate ratio of more than 10 / 1. Both sexes between 20-60 years. Bleeding tendency. Glucose 6 phosphate deficiency. Skin infection at the site of injection. Systemic infection. Hypersensitivity to the used medication Diabetic patients Recent history of steroid therapy in the last three months Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/06/2019 Ethical Committee Medical Research Institute University of Alexandria
Ethics Committee Address
Street address City Postal code Country
165 Horreya Avenus, Hadara Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale before intervention then three days, one and three weeks after intervention.
Secondary Outcome Lactate / Pyruvate ratio Before intervention and three days after intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Physical Medicine and Rehabilitation Faculty of Medicine Alexandria university Al kartoom square Alazareta Alexandria 21521 Egypt
Department of Anaesthesia Faculty of Medicine Aswan Univrsty New Aswan, Aswan Aswan 81528 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Taha Tairy Dardeer Alsawy 165 Horreya Aenus Hadara Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia and Pain Management Medical Research Institute Alexandria University 165 Horreya Avenus Hadara Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Laila Abdel Aziz Sabry 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Ahmed Fawzy Elmolla 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Maher AbdulNabi Kamel 165 Horreya Avenus Hadara Alexandria 21561 Egypt
Engi Yousry Hashem 165 Horreya Avenus Hadara Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laila Sabry Lillysabry1@hotmail.com 00201223584610 165 Elhoryea Street Elhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anesthesia and Pain Management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elmulla aelmulla@yahoo.co.uk 00201273332487 165 Elhoryea Street Elhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anesthesia and Pain Management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information