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

NCT06453291 | Recruiting

• 1 other identifier: IAMC002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

CLBP; Neuromodulation; PRP

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Conventional Therapy Group

EXPERIMENTAL

* 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):; Procedure: Standard Physical Therapy

Neuromodulation + PRP Therapy Group

EXPERIMENTAL

* 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):; Procedure: Platelet-Rich-Plasma Therapy

Interventions

NSAIDs (Nonsteroidal Anti-Inflammatory Drugs): DRUG

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.

Also known as: Ibuprofen, Naproxin

Conventional Therapy Group

Standard Physical Therapy PROCEDURE

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

Also known as: Muscle strengthening

Conventional Therapy Group

Neuromodulation via Dorsal Root Ganglion (DRG): PROCEDURE

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.

Also known as: Pulsed RF

Neuromodulation + PRP Therapy Group

Platelet-Rich-Plasma Therapy PROCEDURE

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.

Also known as: platelet concentrates

Neuromodulation + PRP Therapy Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iffat Anwar Medical Complex: lead

Study Sites (1)

Iffat Anwar Medical Complex

Lahore, Pakistan

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Diagnosis-Related Groups

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations

Study Officials

• Shahzad Anwar, MBBS, DOM

  Iffat Anwar Medical Complex, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahzad Anwar, MBBS, DOM

CONTACT

+923009400049; shahzadtirmzi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: July 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)