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NCT Number: NCT06524531

Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain

This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. The trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy.

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Key information

Conditions

Multi-Organ Disorder

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Iffat Anwar Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Shahzad Anwar, DOM, MBBS

CONTACT

[email protected]

+92 345 8477000

Shahzad Anwar, DOM, MBBS

CONTACT

About this study

Low back pain is a common condition, often associated with multifidus muscle dysfunction, which can result from aging, obesity, or limited movement. This dysfunction is characterized by fatty infiltration and loss of muscle function. Surgical procedures involving posterior or transpedicular screw insertion can exacerbate this issue by damaging the multifidus muscle, leading to persistent pain.

This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally, with each side receiving treatment for 6 minutes. In addition, leukocyte-rich PRP will be injected into the multifidus muscle, and patients will undergo a physiotherapy regimen. The primary outcomes will be compared with those of a control group receiving only physical therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Refractory low back pain due to multifidus dysfunction.
  • Pain persisting for more than 6 months despite conventional treatments.
  • Ability to provide informed consent.

Exclusion criteria

  • Previous spinal surgery within the last year.
  • Current use of systemic steroids or immunosuppressive medications.
  • Known bleeding disorders or anticoagulant therapy.
  • Pregnancy or lactation.
  • Severe psychiatric or cognitive disorders.
  • Any Congenital or Non-congenital disorders

Treatment and study plan

Pulsed RF Neuromodulation

Procedure

RF neuromodulation will be applied to the L2 and L3 segments bilaterally. Each segment will receive treatment for 6 minutes, either sequentially or simultaneously on both sides.

Leukocyte-Rich PRP Injection

Biological

Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.

Physiotherapy Alone

Procedure

Standard physiotherapy regimen tailored to each participant's needs. This may include exercises to improve flexibility, strength, and endurance of the back muscles, as well as education on posture and body mechanics.

Primary outcomes

  1. Pain Visual Analog Scale (0-10)

    Time frame: 2 Weeks

    Change in pain intensity from baseline

  2. Pain Visual Analog Scale (0-10)

    Time frame: 3 Months

    Change in pain intensity from baseline

  3. Pain Visual Analog Scale (0-10)

    Time frame: 6 Months

    Change in pain intensity from baseline

  4. Pain Visual Analog Scale (0-10)

    Time frame: 1 Year

    Change in pain intensity from baseline

  5. Oswestry Disability Index (0-50)

    Time frame: 2 Weeks

    Change in disability index from baseline

  6. Oswestry Disability Index (0-50)

    Time frame: 3 Months

    Change in disability index from baseline

  7. Oswestry Disability Index (0-50)

    Time frame: 6 Months

    Change in disability index from baseline

  8. Oswestry Disability Index (0-50)

    Time frame: 1 Year

    Change in disability index from baseline

  9. Hospital Anxiety and Depression Scale (0-14)

    Time frame: 2 Weeks

    Change in anxiety and depression levels from baseline

  10. Hospital Anxiety and Depression Scale (0-14)

    Time frame: 3 Months

    Change in anxiety and depression levels from baseline

  11. Hospital Anxiety and Depression Scale (0-14)

    Time frame: 6 Months

    Change in anxiety and depression levels from baseline

  12. Hospital Anxiety and Depression Scale (0-14)

    Time frame: 1 Year

    Change in anxiety and depression levels from baseline

  13. Quality of Life (0-100)

    Time frame: 2 Weeks

    Change in Quality of life from baseline

  14. Quality of Life (0-100)

    Time frame: 3 Months

    Change in Quality of life from baseline

  15. Quality of Life (0-100)

    Time frame: 6 Months

    Change in Quality of life from baseline

  16. Quality of Life (0-100)

    Time frame: 1 Year

    Change in Quality of life from baseline

Sponsors and collaborators

Lead sponsor

Iffat Anwar Medical Complex

Other

Registry information

Official study title

Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction

Acronym: Multifidus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Sep 19, 2024

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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