Protocol summary

Study aim
مقایسه اثربخشی تزریق داخل عضلانی پلاسمای غنی از پلاکت در برابر تزریق اوزون تحت هدایت سونوگرافی به عضله مولتی‌فیدوس برای کنترل علائم در بیماران مبتلا به کمردرد مزمن غیراختصاصی.
Design
Randomized, parallel-group, single-blind (assessor-blind), two-arm superiority trial with 60 patients (30 per arm). Allocation concealed via sequentially numbered opaque sealed envelopes. Randomization uses variable blocks of 4 and 6 generated with R software.
Settings and conduct
Single-center study at the Sports and Exercise Medicine outpatient clinic of Hazrat-e Rasool General Hospital, Iran University of Medical Sciences. After baseline assessment and concealed allocation, patients receive two ultrasound-guided injections into the multifidus muscle two weeks apart. The outcome assessor and data analyst are blinded to group assignment.
Participants/Inclusion and exclusion criteria
Inclusion: age 18–65; chronic non-specific low back pain lasting ≥3 months; baseline pain ≥4 on VAS; failed 6-week conservative treatment. Exclusion: specific spinal pathology (radiculopathy, stenosis, fracture, infection, tumor); red flags; prior lumbar surgery; recent spinal injections; coagulation disorders; pregnancy; systemic corticosteroid use.
Intervention groups
Intervention group 1: Two sessions of intramuscular autologous PRP injection (platelet concentration 3–5 times baseline) into the multifidus muscle at L4–L5, 2 weeks apart. Intervention group 2: Two sessions of intramuscular oxygen–ozone injection (20 mcg/mL) into the same muscle at the same level and interval. All injections are performed under real-time ultrasound guidance using a multi-site peppering technique.
Main outcome variables
Change in low back pain intensity measured by Visual Analog Scale (0–10) from baseline to 6 months after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140907019073N9
Registration date: 2026-08-08, 1405/05/17
Registration timing: prospective

Last update: 2026-08-08, 1405/05/17
Update count: 0
Registration date
2026-08-08, 1405/05/17
Registrant information
Name
Ali Mazaherinezhad
Name of organization / entity
IUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
mazaherinezhad.a@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-06, 1405/06/15
Expected recruitment end date
2028-03-20, 1407/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Intramuscular Platelet-Rich Plasma Versus Ultrasound-Guided Ozone Injection into the Multifidus Muscle forSymptom Control in Patients with Chronic Non-Specific Low Back Pain: A Randomized Clinical Trial
Public title
Comparison of PRP and Ozone Injection for Chronic Non-Specific Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years Chronic non-specific low back pain lasting at least 3 months Presence of mechanical pain in the lumbar region without clinical evidence of specific causes of low back pain Pain intensity of at least 4 on the Visual Analog Scale (VAS) at the time of study entry Inadequate response to conservative treatments including medication, physiotherapy, exercise therapy, or activity modification during at least the past 6 weeks Ability to cooperate and complete all clinical and functional assessments used in the study Signing the written informed consent form to participate in the study
Exclusion criteria:
Presence of specific causes of low back pain including symptomatic disc herniation with radiculopathy, spinal canal stenosis, unstable spondylolisthesis, fracture, infection, tumor, or inflammatory spinal diseases Presence of Red Flags including unexplained weight loss, fever, history of malignancy, progressive neurological deficit, or cauda equina syndrome History of lumbar spine surgery History of PRP, ozone, or other therapeutic injections in the lumbar region during the past six months Neurological or musculoskeletal diseases affecting spinal and lower limb function Active rheumatologic diseases or uncontrolled systemic diseases Coagulation disorders or use of anticoagulant medications that cannot be temporarily discontinued Presence of active local or systemic infection at the time of injection Pregnancy or breastfeeding Known sensitivity to blood products or impossibility of PRP preparation Systemic corticosteroid use during the past three months Inability to follow up regularly, lack of cooperation in assessments, or voluntary withdrawal from the study at any stage
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization sequence will be generated by an independent researcher who is not involved in participant recruitment, treatment, or outcome assessment. The allocation sequence will be created using the statistical software R (version 4.5) with a random number generation algorithm. Block randomization with randomly varying block sizes of four and six will be applied to ensure balanced group sizes throughout the trial. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE). After a participant completes all baseline assessments, the corresponding envelope will be opened by a designated staff member to reveal the group assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
This trial is designed as a single-blind study. The outcome assessor and the data analyst will be blinded to the participants' group allocation throughout the study period and data analysis. Blinding will be maintained by using coded group labels in all study forms and databases, without revealing the actual treatment received. The physician performing the injections cannot be blinded due to the obvious differences in the preparation and nature of the two injectates (autologous platelet-rich plasma versus medical oxygen-ozone gas mixture). Participants will also be aware of their treatment group for the same reason; however, they will be instructed not to disclose this information to the assessor.
Placebo
Not used
Assignment
Parallel
Other design features
This is a randomized, single-blind (assessor-blind), parallel-group, two-arm clinical trial. Two injection sessions are administered two weeks apart, both under real-time ultrasound guidance targeting the multifidus muscle at the L4–L5 level. A multi-site peppering technique is used for uniform distribution of the injectate. No stratification is applied.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Next to Milad Tower, Central Library Building, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2026-07-19, 1405/04/28
Ethics committee reference number
IR.IUMS.FMD.REC.1405.364

Health conditions studied

1

Description of health condition studied
Chronic Non-Specific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain (M54.5)

Primary outcomes

1

Description
Change in low back pain intensity from baseline to 6 months after the intervention, measured by the Visual Analog Scale (0 to 10).
Timepoint
At baseline (before intervention) and at 6 months after the intervention.
Method of measurement
Visual Analog Scale, a 10-centimeter horizontal line where 0 indicates no pain and 10 indicates the worst pain imaginable. The patient marks the line to indicate their current pain intensity, and the distance from zero is recorded in centimeters.

Secondary outcomes

1

Description
Change in functional disability measured by the Oswestry Disability Index (ODI) from baseline to 6 months after intervention.
Timepoint
Baseline, 1 month, 3 months, and 6 months after intervention.
Method of measurement
Oswestry Disability Index (ODI) questionnaire, a 10-item tool evaluating pain-related disability in daily activities. Total score ranges from 0% (no disability) to 100% (maximum disability).

2

Description
Change in health-related quality of life measured by the EQ-5D-5L questionnaire from baseline to 6 months.
Timepoint
Baseline, 1 month, 3 months, and 6 months.
Method of measurement
EuroQol Five-Dimension Five-Level (EQ-5D-5L) questionnaire assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

3

Description
Change in lumbar flexion range of motion measured by the Modified Schober test from baseline to 6 months.
Timepoint
Baseline, 1 month, 3 months, and 6 months.
Method of measurement
Modified Schober test: a 15 cm distance between two skin marks over the lumbar spine is measured in upright standing and again after maximal forward bending. The difference is recorded in centimeters.

4

Description
Change in trunk extensor muscle endurance measured by the Biering-Sorensen test from baseline to 6 months.
Timepoint
Baseline, 1 month, 3 months, and 6 months.
Method of measurement
Biering-Sorensen test: the time (in seconds) the patient can maintain the unsupported upper body in a horizontal prone position.

5

Description
Change in physical function measured by the Five Times Sit-to-Stand test (5xSTS) from baseline to 6 months.
Timepoint
Baseline, 1 month, 3 months, and 6 months.
Method of measurement
Time (in seconds) required to complete five consecutive sit-to-stand repetitions from a standard chair.

6

Description
Patient-perceived global improvement measured by the Global Rating of Change scale at 1, 3, and 6 months.
Timepoint
1 month, 3 months, and 6 months after intervention (no baseline value).
Method of measurement
15-point Global Rating of Change scale ranging from -7 (a very great deal worse) to +7 (a very great deal better).

7

Description
Frequency of analgesic medication use during follow-up.
Timepoint
Recorded at baseline, 1 month, 3 months, and 6 months.
Method of measurement
Self-reported number of analgesic medication doses per week.

8

Description
Patient satisfaction with the received treatment at follow-up points.
Timepoint
1 month, 3 months, and 6 months after intervention.
Method of measurement
5-point Likert scale (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).

9

Description
Incidence of treatment-related adverse events throughout the study period.
Timepoint
Continuous monitoring from baseline through 6-month follow-up
Method of measurement
Systematic recording of any adverse events (local pain, swelling, hematoma, infection, symptom exacerbation, etc.) in a dedicated form.

10

Description
Change in low back pain intensity from baseline to 1 month after the intervention, measured by the Visual Analog Scale.
Timepoint
Baseline and 1 month after intervention.
Method of measurement
Visual Analog Scale (0–10 cm), as described for the primary outcome.

11

Description
Change in low back pain intensity from baseline to 3 months after the intervention, measured by the Visual Analog Scale.
Timepoint
Baseline and 3 months after intervention.
Method of measurement
Visual Analog Scale (0–10 cm), as described for the primary outcome.

Intervention groups

1

Description
Intervention group 1: Two sessions of intramuscular injection of autologous platelet-rich plasma (PRP) into the multifidus muscle at the L4–L5 level, 2 weeks apart. For each session, 40 mL of peripheral venous blood is drawn and processed with a double-centrifugation protocol (10 minutes at 1600 rpm, then 6 minutes at 3500 rpm) to yield approximately 5 mL of PRP with a platelet concentration 3–5 times that of whole blood. Injections are performed bilaterally under real-time ultrasound guidance using a 23-gauge needle and a multi-site peppering technique (4 functional points per side) to ensure uniform distribution within the muscle belly.
Category
Treatment - Other

2

Description
Intervention group 2: Two sessions of intramuscular injection of medical oxygen–ozone mixture into the multifidus muscle at the L4–L5 level, 2 weeks apart. The gas mixture is prepared using a standard medical ozone generator at a concentration of 20 micrograms per milliliter. A total volume of 20 milliliters (5 mL per functional point) is injected bilaterally per session. Injections are performed under real-time ultrasound guidance with a 23-gauge needle and the identical multi-site peppering technique (4 points per side) as in the PRP group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Ali Mazaherinezhad
Street address
Maziar Mansouri, StreetSattar Khan Street, Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Email
mazaherinezhad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Email
intl@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Ali Mazaherinezhad
Position
Sports medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2446
Fax
Email
Mazaherinezhad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mazaherinezhad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Hazrate-rasool-Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2446
Fax
+98 21 6650 9108
Email
mazaherinezhad.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mazaherinezhad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Hazrate-rasool-Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2446
Fax
+98 21 6650 9108
Email
mazaherinezhad.a@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
De-identified individual participant data (IPD), study protocol, statistical analysis plan (SAP), data dictionary, analysis code (R scripts), and the informed consent form will be available. All shared datasets will be fully de-identified to protect participant confidentiality.
When the data will become available and for how long
Beginning 6 months after publication of the primary study results and available for 5 years.
To whom data/document is available
Qualified researchers affiliated with academic or research institutions whose proposed use has been approved by the principal investigator.
Under which criteria data/document could be used
Data may be used only for scientifically sound secondary analyses after submission of a research proposal and approval by the principal investigator. Users must agree not to attempt participant re-identification and must comply with applicable ethical regulations.
From where data/document is obtainable
Requests should be sent to the Principal Investigator via the corresponding author's institutional email address.
What processes are involved for a request to access data/document
Requests will be reviewed by the study investigators within approximately four weeks. Approved applicants will receive the requested materials after signing a data sharing agreement, if applicable.
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