Multi-Organ Disorder
Conditions
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.
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.
Sponsors
Iffat Anwar Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale (0-10) | 2 Weeks | Change in pain intensity from baseline |
| Oswestry Disability Index (0-50) | 2 Weeks | Change in disability index from baseline |
| Hospital Anxiety and Depression Scale (0-14) | 2 Weeks | Change in anxiety and depression levels from baseline |
| Quality of Life (0-100) | 2 Weeks | Change in Quality of life from baseline |
Countries
Pakistan
Outcome results
None listed