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

NCT ID: NCT06453291

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-05-31

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.

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.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):

Intervention Type: 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.

Standard Physical Therapy

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Neuromodulation via Dorsal Root Ganglion (DRG):

Intervention Type: 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.

Platelet-Rich-Plasma Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Ibuprofen; Naproxin; Muscle strengthening; Pulsed RF; platelet concentrates

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iffat Anwar Medical Complex

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahzad Anwar, MBBS, DOM

Role: PRINCIPAL_INVESTIGATOR

Iffat Anwar Medical Complex, Lahore

Locations

Iffat Anwar Medical Complex

Lahore, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Shahzad Anwar, MBBS, DOM

Role: CONTACT

shahzadtirmzi@yahoo.com

+923009400049

Facility Contacts

Shahzad Anwar, MBBS,DOM

Role: primary

shahzadtirmzi@yahoo.com

03009400049

References

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.

Reference Type: BACKGROUND

PMID: 30288088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25395117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24192391 (View on PubMed)

Other Identifiers

IAMC002

Identifier Type: -

Identifier Source: org_study_id