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

Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction

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.

Study Overview

• Status: Recruiting
• Conditions: Multi-Organ Disorder
• Intervention / Treatment: Procedure: Pulsed RF Neuromodulation; Biological: Leukocyte-Rich PRP Injection; Procedure: Physiotherapy Alone

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Iffat Anwar Medical Complex
      • Contact: Shahzad Anwar, DOM, MBBS; Phone Number: +92 345 8477000; Email: shahzadtirmzi@yahoo.com
      • Principal Investigator: Shahzad Anwar, DOM, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	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.
Experimental: Control Group; Physiotherapy: Standard physiotherapy regimen only	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Iffat Anwar Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 003 (033)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No