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Recruiting NCT06453291

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

No phase Interventional Chronic Low Back Pain (CLBP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):, Standard Physical Therapy, Neuromodulation via Dorsal Root Ganglion (DRG):, Platelet-Rich-Plasma Therapy.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain (CLBP). Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):
    Objective: To reduce pain and inflammation associated with chronic low back pain. Medications: Ibuprofen, Naproxen, or Diclofenac. Dosage: Ibuprofen: 400-600 mg every 6-8 hours as needed. Naproxen: 250-500 mg twice daily as needed. Diclofenac: 50 mg three times daily as needed. Administration: Oral tablets. Duration: Daily use as prescribed, for the duration of the study. Monitoring: Regular follow-up visits to monitor pain levels, side effects, and adherence.
  • Procedure Standard Physical Therapy
    Objective: To improve mobility, strength, and reduce pain. Techniques: Stretching exercises. Strengthening exercises for core and back muscles. Manual therapy techniques. Postural training. Frequency: Twice a week sessions. Duration: 45-60 minutes per session. Monitoring: Progress will be assessed during each session and adjusted as necessary
  • Procedure Neuromodulation via Dorsal Root Ganglion (DRG):
    Objective: To modulate excitatory pathways and reduce pain through targeted stimulation. Procedure: Placement of electrodes near the DRG. Application of pulsed radiofrequency (RF) at 42°C for 3-20 minutes. Frequency: Initial treatment: Once a week for the first month. Maintenance: Monthly sessions if needed. Duration: Each session lasts approximately 30-45 minutes. Monitoring: Pain levels and functional improvement will be assessed before and after each session.
  • Procedure Platelet-Rich-Plasma Therapy
    Objective: To promote healing and reduce inflammation through the application of concentrated platelets. Procedure: Blood draw from the patient. Centrifugation to separate platelets. Injection of PRP into the affected area of the lower back. Frequency: Initial treatment: Once a week for the first three weeks. Follow-up: Additional injections may be given based on patient response and clinical judgment. Duration: Each session lasts approximately 30-45 minutes. Monitoring: Pain levels, inflam

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: 0 Weeks]
  • Visual Analog Scale (VAS) [Time frame: 2 Weeks]
  • Visual Analog Scale (VAS) [Time frame: 3 Months]
  • Visual Analog Scale (VAS) [Time frame: 6 Months]
  • Visual Analog Scale (VAS) [Time frame: 12 Months]
  • Oswestry Disability Index (ODI) [Time frame: 0 weeks]
  • Oswestry Disability Index (ODI) [Time frame: 2 weeks]
  • Oswestry Disability Index (ODI) [Time frame: 3 Months]
  • Oswestry Disability Index (ODI) [Time frame: 6 Months]
  • Oswestry Disability Index (ODI) [Time frame: 12 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Iffat Anwar Medical Complex — Lahore

Publications

  • Ho KY, Gwee KA, Cheng YK, Yoon KH, Hee HT, Omar AR. Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice. J Pain Res. 2018 Sep 20;11:1937-1948. doi: 10.2147/JPR.S168188. eCollection 2018. PMID 30288088
  • Deer T, Pope J, Hayek S, Narouze S, Patil P, Foreman R, Sharan A, Levy R. Neurostimulation for the treatment of axial back pain: a review of mechanisms, techniques, outcomes, and future advances. Neuromodulation. 2014 Oct;17 Suppl 2:52-68. doi: 10.1111/j.1525-1403.2012.00530.x. PMID 25395117
  • Sundman EA, Cole BJ, Karas V, Della Valle C, Tetreault MW, Mohammed HO, Fortier LA. The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. Am J Sports Med. 2014 Jan;42(1):35-41. doi: 10.1177/0363546513507766. Epub 2013 Nov 5. PMID 24192391

Identifiers

NCT: NCT06453291 · IAMC002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗