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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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 will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.
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.
Iffat Anwar Medical Complex
Lahore, Punjab Province, Pakistan
RECRUITINGPain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Time frame: 2 Weeks
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Time frame: 3 Months
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Time frame: 6 Months
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Time frame: 1 Year
Oswestry Disability Index (0-50)
Change in disability index from baseline
Time frame: 2 Weeks
Oswestry Disability Index (0-50)
Change in disability index from baseline
Time frame: 3 Months
Oswestry Disability Index (0-50)
Change in disability index from baseline
Time frame: 6 Months
Oswestry Disability Index (0-50)
Change in disability index from baseline
Time frame: 1 Year
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Time frame: 2 Weeks
Hospital Anxiety and Depression Scale (0-14)
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Change in anxiety and depression levels from baseline
Time frame: 3 Months
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Time frame: 6 Months
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Time frame: 1 Year
Quality of Life (0-100)
Change in Quality of life from baseline
Time frame: 2 Weeks
Quality of Life (0-100)
Change in Quality of life from baseline
Time frame: 3 Months
Quality of Life (0-100)
Change in Quality of life from baseline
Time frame: 6 Months
Quality of Life (0-100)
Change in Quality of life from baseline
Time frame: 1 Year