Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain
NCT06524531 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-09-19
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.
Conditions
- Multi-Organ Disorder
Interventions
- PROCEDURE
-
Pulsed 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.
- BIOLOGICAL
-
Leukocyte-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.
- PROCEDURE
-
Physiotherapy 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 & Collaborators
-
Iffat Anwar Medical Complex
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-10
- Primary Completion
- 2025-07-10
- Completion
- 2025-12-30
Countries
- Pakistan
Study Locations
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