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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Drug: NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):; Procedure: Standard Physical Therapy; Procedure: Neuromodulation via Dorsal Root Ganglion (DRG):; Procedure: Platelet-Rich-Plasma 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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shahzad Anwar, MBBS, DOM; Phone Number: +923009400049; Email: shahzadtirmzi@yahoo.com

Study Locations

• Pakistan
  • Lahore, Pakistan
    • Recruiting
    • Iffat Anwar Medical Complex
    • Contact: Shahzad Anwar, MBBS,DOM; Phone Number: 03009400049; Email: shahzadtirmzi@yahoo.com
    • Principal Investigator: Shahzad Anwar, MBBS,DOM
    • Sub-Investigator: Muhammad Waseem Hassan, MBBS
    • Sub-Investigator: Muhammad Umar Saeed, MBBS
    • Sub-Investigator: Fatima Tirmzi, MBBS
    • Sub-Investigator: Gull a Rukh, MS
    • Sub-Investigator: Sulayman Waquar, Ph.D,M.Phil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Ibuprofen; Naproxin; 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; Other Names: Muscle strengthening
Experimental: 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.	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.; Other Names: Pulsed RF; 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, inflammation markers, and functional improvement will be assessed before and after each injection.; Other Names: platelet concentrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Improvement in the Visual Analog Scale (VAS)	0 Weeks
Visual Analog Scale (VAS)	Improvement in the Visual Analog Scale (VAS)	2 Weeks
Visual Analog Scale (VAS)	Improvement in the Visual Analog Scale (VAS)	3 Months
Visual Analog Scale (VAS)	Improvement in the Visual Analog Scale (VAS)	6 Months
Visual Analog Scale (VAS)	Improvement in the Visual Analog Scale (VAS)	12 Months
Oswestry Disability Index (ODI)	Improvement in the Oswestry Disability Index (ODI)	0 weeks
Oswestry Disability Index (ODI)	Improvement in the Oswestry Disability Index (ODI)	2 weeks
Oswestry Disability Index (ODI)	Improvement in the Oswestry Disability Index (ODI)	3 Months
Oswestry Disability Index (ODI)	Improvement in the Oswestry Disability Index (ODI)	6 Months
Oswestry Disability Index (ODI)	Improvement in the Oswestry Disability Index (ODI)	12 Months
Hospital Anxiety Depression (HAD)	Improvement in the Hospital Anxiety Depression (HAD)	0 Weeks
Hospital Anxiety Depression (HAD)	Improvement in the Hospital Anxiety Depression (HAD)	2 Weeks
Hospital Anxiety Depression (HAD)	Improvement in the Hospital Anxiety Depression (HAD)	3 Months
Hospital Anxiety Depression (HAD)	Improvement in the Hospital Anxiety Depression (HAD)	6 Months
Hospital Anxiety Depression (HAD)	Improvement in the Hospital Anxiety Depression (HAD)	12 Months

Collaborators and Investigators

• Sponsor: Iffat Anwar Medical Complex
• Investigators: Principal Investigator: Shahzad Anwar, MBBS, DOM, Iffat Anwar Medical Complex, Lahore

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Neuromodulation; CLBP; PRP
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Inflammatory Agents; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: IAMC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No