Chronic Low Back Pain (CLBP) Clinical Trial
— CLBPOfficial title:
Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques
NCT number | NCT06453291 |
Other study ID # | IAMC002 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2024 |
Est. completion date | May 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Iffat Anwar Medical Complex | Lahore |
Lead Sponsor | Collaborator |
---|---|
Iffat Anwar Medical Complex |
Pakistan,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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