Clinical trial NCT06453291: Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain
Official title: Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: CLBP
Neuromodulation
PRP
Lead sponsor: Iffat Anwar Medical Complex
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 0 Weeks
measure: Visual Analog Scale (VAS)
timeFrame: 2 Weeks
measure: Visual Analog Scale (VAS)
timeFrame: 3 Months
measure: Visual Analog Scale (VAS)
timeFrame: 6 Months
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 0 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: 2 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: 3 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 6 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 Months
measure: Hospital Anxiety Depression (HAD)
timeFrame: 0 Weeks
measure: Hospital Anxiety Depression (HAD)
timeFrame: 2 Weeks
measure: Hospital Anxiety Depression (HAD)
timeFrame: 3 Months
measure: Hospital Anxiety Depression (HAD)
timeFrame: 6 Months
measure: Hospital Anxiety Depression (HAD)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Iffat Anwar Medical Complex
Study officials:
affiliation: Iffat Anwar Medical Complex, Lahore
name: Shahzad Anwar, MBBS, DOM
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.