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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Therapy Group | Experimental |
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| Neuromodulation + PRP Therapy Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahzad Anwar, MBBS, DOM | Contact | +923009400049 | shahzadtirmzi@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Shahzad Anwar, MBBS, DOM | Iffat Anwar Medical Complex, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iffat Anwar Medical Complex | Recruiting | Lahore | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30288088 | Background | 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. | |
| 25395117 | 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. |
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Parallel Assignment
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| 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 |
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| 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. |
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| 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. |
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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 |
| 24192391 | 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. |
| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D007052 | Ibuprofen |
| D003953 | Diagnosis-Related Groups |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D011445 | Prospective Payment System |
| D012051 | Reimbursement Mechanisms |
| D007349 | Insurance, Health, Reimbursement |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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