NCT Number: NCT06453291
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.
Interested in participating?
Request Info40 year–60 year
All sexes
Interventional
Not applicable
Lahore, Pakistan
Location status: Recruiting
Fatima Tirmzi, MBBS
SUB_INVESTIGATOR
Gull a Rukh, MS
SUB_INVESTIGATOR
Muhammad Umar Saeed, MBBS
SUB_INVESTIGATOR
Muhammad Waseem Hassan, MBBS
SUB_INVESTIGATOR
Shahzad Anwar, MBBS,DOM
CONTACT
Shahzad Anwar, MBBS,DOM
PRINCIPAL_INVESTIGATOR
Sulayman Waquar, Ph.D,M.Phil
SUB_INVESTIGATOR
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:
The study will provide valuable insights into the comparative effectiveness of these treatments, potentially guiding future therapeutic strategies for CLBP.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
Time frame: 0 Weeks
Improvement in the Visual Analog Scale (VAS)
Time frame: 2 Weeks
Improvement in the Visual Analog Scale (VAS)
Time frame: 3 Months
Improvement in the Visual Analog Scale (VAS)
Time frame: 6 Months
Improvement in the Visual Analog Scale (VAS)
Time frame: 12 Months
Improvement in the Visual Analog Scale (VAS)
Time frame: 0 weeks
Improvement in the Oswestry Disability Index (ODI)
Time frame: 2 weeks
Improvement in the Oswestry Disability Index (ODI)
Time frame: 3 Months
Improvement in the Oswestry Disability Index (ODI)
Time frame: 6 Months
Improvement in the Oswestry Disability Index (ODI)
Time frame: 12 Months
Improvement in the Oswestry Disability Index (ODI)
Time frame: 0 Weeks
Improvement in the Hospital Anxiety Depression (HAD)
Time frame: 2 Weeks
Improvement in the Hospital Anxiety Depression (HAD)
Time frame: 3 Months
Improvement in the Hospital Anxiety Depression (HAD)
Time frame: 6 Months
Improvement in the Hospital Anxiety Depression (HAD)
Time frame: 12 Months
Improvement in the Hospital Anxiety Depression (HAD)
Contact information is provided by the study sponsor or research team.
Iffat Anwar Medical Complex
Other
Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques
Acronym: CLBP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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