Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain

Not Applicable

Recruiting

• Conditions: Chronic Low Back Pain (CLBP)
• Interventions: Procedure: Platelet-Rich-Plasma Therapy; Procedure: Standard Physical Therapy

• Registration Number: NCT06453291
• Lead Sponsor: Iffat Anwar Medical Complex

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-07
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

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

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromodulation + PRP Therapy Group	Platelet-Rich-Plasma Therapy	* 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.
Conventional Therapy Group	Standard Physical Therapy	* 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

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	12 Months	Improvement in the Visual Analog Scale (VAS)
Oswestry Disability Index (ODI)	12 Months	Improvement in the Oswestry Disability Index (ODI)
Hospital Anxiety Depression (HAD)	12 Months	Improvement in the Hospital Anxiety Depression (HAD)

Trial Locations

Locations (1)

Iffat Anwar Medical Complex; 🇵🇰 Lahore, Pakistan