Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Iffat Anwar Medical Complex
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
Study 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:
- Conventional Therapy: This includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and other standard physical therapy techniques.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 (Procedure)
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 (Procedure)
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)
Secondary Outcomes
No secondary outcomes reported