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

Last updated: September 2, 2024
Sponsor: Iffat Anwar Medical Complex
Overall Status: Active - Recruiting

Phase

1

Condition

Chronic Pain

Treatment

Leukocyte-Rich PRP Injection

Physiotherapy Alone

Pulsed RF Neuromodulation

Clinical Study ID

NCT06524531
IAMC003
  • Ages 30-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Leukocyte-Rich PRP Injection
Phase: 1
Study Start date:
July 10, 2024
Estimated Completion Date:
December 30, 2025

Study Description

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.

Connect with a study center

  • Iffat Anwar Medical Complex

    Lahore, Punjab 54000
    Pakistan

    Active - Recruiting

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