Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone on lumbar discopathy

Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone in patients with lumbar discopathy in terms of quality of life

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200107046039N1

Enrollment

Registered

2020-06-09

Start date

2020-02-20

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Lumbar radiculopathy, Lumbar discopathy, Low back pain. Condition 2: lumbar radiculopathy. Intervertebral disc disorders with radiculopathy Radiculopathy, lumbar region

Interventions

Intervention 1: The patient receives intradiscal nucleoplasty of responsible disc(s) in prone position using diode laser PW 3.5 to 5 W 1200 to 1500 j.Before removal of intradiscal needle, 2 ml of ozo

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Low back pain With lower limb radicular symptoms Spinal MRI indicates inter-vertebral disc(s) protrusion of L3-L4, L4-L5 or L5-S1 Failure of conservative treatments and peri-root injection

Exclusion criteria

Exclusion criteria: Previous back surgery Coagulation disorder Drug abuse Known non-treated psychiatric disorders Lower extremity weakness Sphincter disorder Disc protrusion more than one third of anterior-posterior spinal column in MRI Sequestration or extrusion of inter-vertebral disc in MRI

Design outcomes

Primary

Measure	Time frame
Numeric Rating Scale (NRS): An 11-point numeric rating scale is a simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain). Timepoint: Before intervention, one, six and 12 month after intervention. Method of measurement: An 11-point numeric rating scale is a simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain) and they select a number.;(Oswestry Disability Index (ODI): self-filled questionnaire by patient which indicates disability from low back pain. Timepoint: Before intervention, one, six and 12 month after intervention. Method of measurement: The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.	—

Measure

Time frame

Numeric Rating Scale (NRS): An 11-point numeric rating scale is a simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain). Timepoint: Before intervention, one, six and 12 month after intervention. Method of measurement: An 11-point numeric rating scale is a simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain) and they select a number.;(Oswestry Disability Index (ODI): self-filled questionnaire by patient which indicates disability from low back pain. Timepoint: Before intervention, one, six and 12 month after intervention. Method of measurement: The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBabak Babakhani

Tehran University of Medical Sciences

drbabakhani@yahoo.com+98 21 6658 1560

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026