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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524531 on ClinicalTrials.gov