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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06453291
Other study ID # IAMC002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date May 2025

Study information

Verified date June 2024
Source Iffat Anwar Medical Complex
Contact Shahzad Anwar, MBBS, DOM
Phone +923009400049
Email shahzadtirmzi@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2025
Est. primary completion date April 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
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.
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, inflammation markers, and functional improvement will be assessed before and after each injection.

Locations

Country Name City State
Pakistan Iffat Anwar Medical Complex Lahore

Sponsors (1)

Lead Sponsor Collaborator
Iffat Anwar Medical Complex

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Improvement in the Visual Analog Scale (VAS) 0 Weeks
Primary Visual Analog Scale (VAS) Improvement in the Visual Analog Scale (VAS) 2 Weeks
Primary Visual Analog Scale (VAS) Improvement in the Visual Analog Scale (VAS) 3 Months
Primary Visual Analog Scale (VAS) Improvement in the Visual Analog Scale (VAS) 6 Months
Primary Visual Analog Scale (VAS) Improvement in the Visual Analog Scale (VAS) 12 Months
Primary Oswestry Disability Index (ODI) Improvement in the Oswestry Disability Index (ODI) 0 weeks
Primary Oswestry Disability Index (ODI) Improvement in the Oswestry Disability Index (ODI) 2 weeks
Primary Oswestry Disability Index (ODI) Improvement in the Oswestry Disability Index (ODI) 3 Months
Primary Oswestry Disability Index (ODI) Improvement in the Oswestry Disability Index (ODI) 6 Months
Primary Oswestry Disability Index (ODI) Improvement in the Oswestry Disability Index (ODI) 12 Months
Primary Hospital Anxiety Depression (HAD) Improvement in the Hospital Anxiety Depression (HAD) 0 Weeks
Primary Hospital Anxiety Depression (HAD) Improvement in the Hospital Anxiety Depression (HAD) 2 Weeks
Primary Hospital Anxiety Depression (HAD) Improvement in the Hospital Anxiety Depression (HAD) 3 Months
Primary Hospital Anxiety Depression (HAD) Improvement in the Hospital Anxiety Depression (HAD) 6 Months
Primary Hospital Anxiety Depression (HAD) Improvement in the Hospital Anxiety Depression (HAD) 12 Months
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT02615418 - Non Invasive Brain Stimulation Treatment for CLBP N/A