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

Chronic Low Back Pain (CLBP) Clinical Trial

— CLBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453291
• Other study ID #: IAMC002
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain (CLBP)
• Low Back Pain

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