RecruitingEarly Phase 1NCT06524531

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

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


Sponsor

Iffat Anwar Medical Complex

Enrollment

100 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • 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

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Interventions

PROCEDUREPulsed RF Neuromodulation

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.

BIOLOGICALLeukocyte-Rich PRP Injection

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

PROCEDUREPhysiotherapy Alone

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.


Locations(1)

Iffat Anwar Medical Complex

Lahore, Punjab Province, Pakistan

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NCT06524531


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