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Clinical Trials/NCT06453291
NCT06453291
Recruiting
Not Applicable

Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques

Iffat Anwar Medical Complex1 site in 1 country100 target enrollmentJuly 2024

Overview

Phase
Not Applicable
Intervention
Standard Physical Therapy
Conditions
Chronic Low Back Pain (CLBP)
Sponsor
Iffat Anwar Medical Complex
Enrollment
100
Locations
1
Primary Endpoint
Visual Analog Scale (VAS)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This clinical trial aims to assess the effectiveness of different clinical techniques in treating patients with chronic low back pain (CLBP). Two test groups will be included: one receiving conventional therapy (NSAIDs and other physical therapy techniques) and the other receiving a combination of neuromodulation and platelet-rich plasma (PRP) therapy. Chronic pain, persisting for more than three months, inhibits natural pathways like GABA and promotes excitatory pathways, leading to increased inflammation. The study hypothesizes that neuromodulation via the dorsal root ganglion (DRG) and PRP therapy will provide superior pain relief and functional improvement compared to conventional therapy.

Detailed Description

Chronic low back pain (CLBP) affects millions of individuals worldwide, significantly impacting quality of life and productivity. Traditional treatments often involve NSAIDs and physical therapy, but these methods sometimes fail to provide adequate relief. Chronic pain is characterized by prolonged activation of the central and peripheral nervous systems, resulting in sensitization and increased pain perception. The current study will evaluate two treatment modalities: 1. Conventional Therapy: This includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and other standard physical therapy techniques. 2. Neuromodulation + PRP Therapy: Neuromodulation is performed via the DRG to modulate excitatory pathways, with medial sensory nerves being desensitized at 42°C for 3-20 minutes. PRP therapy involves the injection of concentrated platelets to promote healing and reduce inflammation. The study will provide valuable insights into the comparative effectiveness of these treatments, potentially guiding future therapeutic strategies for CLBP.

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults aged 40-60 years.
  • Diagnosed with chronic low back pain persisting for more than three months.
  • Willingness to participate and comply with study procedures.
  • Ability to provide informed consent.

Exclusion Criteria

  • Comorbidities.
  • Contagious and Non-Contagious Infections
  • Known hypersensitivity to study interventions.
  • Presence of severe psychiatric disorders.
  • Pregnancy or breastfeeding.
  • Participation in another clinical trial within the last 30 days.

Arms & Interventions

Conventional Therapy Group

* Intervention: Participants will receive standard treatment for CLBP, including NSAIDs and physical therapy. * Frequency: Daily NSAID use as prescribed, physical therapy sessions twice a week

Intervention: Standard Physical Therapy

Neuromodulation + PRP Therapy Group

* Intervention: Participants will undergo neuromodulation via the DRG and receive PRP injections. * Frequency: Neuromodulation sessions once a week for the first month, followed by monthly maintenance sessions if needed. PRP injections will be administered once a week for the first three weeks.

Intervention: Platelet-Rich-Plasma Therapy

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

Time Frame: 12 Months

Improvement in the Visual Analog Scale (VAS)

Oswestry Disability Index (ODI)

Time Frame: 12 Months

Improvement in the Oswestry Disability Index (ODI)

Hospital Anxiety Depression (HAD)

Time Frame: 12 Months

Improvement in the Hospital Anxiety Depression (HAD)

Study Sites (1)

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