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

Iffat Anwar Medical Complex

Status and phase

Enrolling

Early Phase 1

Conditions

Multi-Organ Disorder

Treatments

Biological: Leukocyte-Rich PRP Injection

Procedure: Physiotherapy Alone

Procedure: Pulsed RF Neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06524531

IAMC003

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

100 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Pulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each. Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen.

Treatment: