Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Control Group | Experimental | Physiotherapy: Standard physiotherapy regimen only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed RF Neuromodulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale (0-10) | Change in pain intensity from baseline | 2 Weeks |
| Pain Visual Analog Scale (0-10) | Change in pain intensity from baseline | 3 Months |
| Pain Visual Analog Scale (0-10) | Change in pain intensity from baseline | 6 Months |
| Pain Visual Analog Scale (0-10) | Change in pain intensity from baseline | 1 Year |
| Oswestry Disability Index (0-50) | Change in disability index from baseline | 2 Weeks |
| Oswestry Disability Index (0-50) | Change in disability index from baseline | 3 Months |
| Oswestry Disability Index (0-50) | Change in disability index from baseline | 6 Months |
| Oswestry Disability Index (0-50) | Change in disability index from baseline | 1 Year |
| Hospital Anxiety and Depression Scale (0-14) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iffat Anwar Medical Complex | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Leukocyte-Rich PRP Injection | Biological | Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels. |
|
| Physiotherapy Alone | Procedure | 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. |
|
Change in anxiety and depression levels from baseline
| 2 Weeks |
| Hospital Anxiety and Depression Scale (0-14) | Change in anxiety and depression levels from baseline | 3 Months |
| Hospital Anxiety and Depression Scale (0-14) | Change in anxiety and depression levels from baseline | 6 Months |
| Hospital Anxiety and Depression Scale (0-14) | Change in anxiety and depression levels from baseline | 1 Year |
| Quality of Life (0-100) | Change in Quality of life from baseline | 2 Weeks |
| Quality of Life (0-100) | Change in Quality of life from baseline | 3 Months |
| Quality of Life (0-100) | Change in Quality of life from baseline | 6 Months |
| Quality of Life (0-100) | Change in Quality of life from baseline | 1 Year |