Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction
Overview
- Phase
- Early Phase 1
- Intervention
- Pulsed RF Neuromodulation
- Conditions
- Multi-Organ Disorder
- Sponsor
- Iffat Anwar Medical Complex
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index (0-50)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental Group
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.
Intervention: Pulsed RF Neuromodulation
Experimental Group
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.
Intervention: Leukocyte-Rich PRP Injection
Control Group
Physiotherapy: Standard physiotherapy regimen only
Intervention: Physiotherapy Alone
Outcomes
Primary Outcomes
Oswestry Disability Index (0-50)
Time Frame: 1 Year
Change in disability index from baseline
Pain Visual Analog Scale (0-10)
Time Frame: 1 Year
Change in pain intensity from baseline
Quality of Life (0-100)
Time Frame: 1 Year
Change in Quality of life from baseline
Hospital Anxiety and Depression Scale (0-14)
Time Frame: 1 Year
Change in anxiety and depression levels from baseline