Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain

Early Phase 1

Recruiting

• Conditions: Multi-Organ Disorder
• Interventions: Procedure: Pulsed RF Neuromodulation; Procedure: Physiotherapy Alone; Biological: Leukocyte-Rich PRP Injection

• Registration Number: NCT06524531
• Lead Sponsor: Iffat Anwar Medical Complex

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.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-10
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-29
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07-10
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Group	Leukocyte-Rich PRP Injection	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.
Experimental Group	Pulsed RF Neuromodulation	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	Physiotherapy Alone	Physiotherapy: Standard physiotherapy regimen only

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (0-50)	1 Year	Change in disability index from baseline
Pain Visual Analog Scale (0-10)	1 Year	Change in pain intensity from baseline
Quality of Life (0-100)	1 Year	Change in Quality of life from baseline
Hospital Anxiety and Depression Scale (0-14)	1 Year	Change in anxiety and depression levels from baseline

Trial Locations

Locations (1)

Iffat Anwar Medical Complex; 🇵🇰 Lahore, Punjab, Pakistan