Clinical trial NCT06524531: Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain
Official title: Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Multi-Organ Disorder
Lead sponsor: Iffat Anwar Medical Complex
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Visual Analog Scale (0-10)
timeFrame: 2 Weeks
measure: Pain Visual Analog Scale (0-10)
timeFrame: 3 Months
measure: Pain Visual Analog Scale (0-10)
timeFrame: 6 Months
measure: Pain Visual Analog Scale (0-10)
timeFrame: 1 Year
measure: Oswestry Disability Index (0-50)
timeFrame: 2 Weeks
measure: Oswestry Disability Index (0-50)
timeFrame: 3 Months
measure: Oswestry Disability Index (0-50)
timeFrame: 6 Months
measure: Oswestry Disability Index (0-50)
timeFrame: 1 Year
measure: Hospital Anxiety and Depression Scale (0-14)
timeFrame: 2 Weeks
measure: Hospital Anxiety and Depression Scale (0-14)
timeFrame: 3 Months
measure: Hospital Anxiety and Depression Scale (0-14)
timeFrame: 6 Months
measure: Hospital Anxiety and Depression Scale (0-14)
timeFrame: 1 Year
measure: Quality of Life (0-100)
timeFrame: 2 Weeks
measure: Quality of Life (0-100)
timeFrame: 3 Months
measure: Quality of Life (0-100)
timeFrame: 6 Months
measure: Quality of Life (0-100)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Iffat Anwar Medical Complex
state: Punjab
Study officials:
References: