Chronic Low Back Pain (CLBP)CLBPNCT06453291
Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain
A study testing NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):, Standard Physical Therapy and Neuromodulation via Dorsal Root Ganglion (DRG): in people with Chronic Low Back Pain (CLBP), run by Iffat Anwar Medical Complex at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):, Standard Physical Therapy and Neuromodulation via Dorsal Root Ganglion (DRG):
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Iffat Anwar Medical Complex
Lahore
Shahzad Anwar, MBBS,DOM, 03009400049, shahzadtirmzi@yahoo.com
Shahzad Anwar, MBBS,DOM
About this study
Official title: Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques
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.
Read the 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:
- Conventional Therapy: This includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and other standard physical therapy techniques.
- 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)
- Being tested
- NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):, Standard Physical Therapy, Neuromodulation via Dorsal Root Ganglion (DRG):, Platelet-Rich-Plasma Therapy
- Keywords
- CLBP, Neuromodulation, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):Drug
Also called Ibuprofen, Naproxin
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 TherapyProcedure or surgery
Also called Muscle strengthening
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 via Dorsal Root Ganglion (DRG):Procedure or surgery
Also called Pulsed RF
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 TherapyProcedure or surgery
Also called platelet concentrates
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy Group | Experimental | * 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 Receives: Drug: NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):; Procedure: Standard Physical Therapy |
| Neuromodulation + PRP Therapy Group | Experimental | * 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. Receives: Procedure: Neuromodulation via Dorsal Root Ganglion (DRG):; Procedure: Platelet-Rich-Plasma Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Improvement in the Visual Analog Scale (VAS)
Measured: 0 Weeks
Visual Analog Scale (VAS)
Improvement in the Visual Analog Scale (VAS)
Measured: 2 Weeks
Visual Analog Scale (VAS)
Improvement in the Visual Analog Scale (VAS)
Measured: 3 Months
Visual Analog Scale (VAS)
Improvement in the Visual Analog Scale (VAS)
Measured: 6 Months
Visual Analog Scale (VAS)
Improvement in the Visual Analog Scale (VAS)
Measured: 12 Months
Oswestry Disability Index (ODI)
Improvement in the Oswestry Disability Index (ODI)
Measured: 0 weeks
Oswestry Disability Index (ODI)
Improvement in the Oswestry Disability Index (ODI)
Measured: 2 weeks
Oswestry Disability Index (ODI)
Improvement in the Oswestry Disability Index (ODI)
Measured: 3 Months
Oswestry Disability Index (ODI)
Improvement in the Oswestry Disability Index (ODI)
Measured: 6 Months
Oswestry Disability Index (ODI)
Improvement in the Oswestry Disability Index (ODI)
Measured: 12 Months
Hospital Anxiety Depression (HAD)
Improvement in the Hospital Anxiety Depression (HAD)
Measured: 0 Weeks
Hospital Anxiety Depression (HAD)
Improvement in the Hospital Anxiety Depression (HAD)
Measured: 2 Weeks
Hospital Anxiety Depression (HAD)
Improvement in the Hospital Anxiety Depression (HAD)
Measured: 3 Months
Hospital Anxiety Depression (HAD)
Improvement in the Hospital Anxiety Depression (HAD)
Measured: 6 Months
Hospital Anxiety Depression (HAD)
Improvement in the Hospital Anxiety Depression (HAD)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 Jul 2024
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iffat Anwar Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahzad Anwar, MBBS, DOM, Principal investigator, Iffat Anwar Medical Complex, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453291
- Sponsor's protocol ID
- IAMC002
- Acronym
- CLBP
- Status last verified
- Sep 2024
- First submitted
- 7 Jun 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30288088Deer 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.
PubMed 25395117Sundman 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.
PubMed 24192391
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques
- ClinicalTrials.gov ID
- NCT06453291
- Acronym / sponsor ID
- CLBP / IAMC002
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- CLBP, Neuromodulation, PRP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iffat Anwar Medical ComplexUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Conventional Therapy: This includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and other standard physical therapy techniques.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy Group | Experimental | Drug: NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):, Procedure: Standard Physical Therapy* 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 |
| Neuromodulation + PRP Therapy Group | Experimental | Procedure: Neuromodulation via Dorsal Root Ganglion (DRG):, Procedure: Platelet-Rich-Plasma Therapy* 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Comorbidities.
- Contagious and Non-Contagious Infections
- Known hypersensitivity to study interventions.
- Presence of severe psychiatric disorders.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):Also: Ibuprofen, NaproxinObjective: 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. | Drug | Conventional Therapy Group |
| Standard Physical TherapyAlso: Muscle strengtheningObjective: 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 | Procedure or surgery | Conventional Therapy Group |
| Neuromodulation via Dorsal Root Ganglion (DRG):Also: Pulsed RFObjective: 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. | Procedure or surgery | Neuromodulation + PRP Therapy Group |
| Platelet-Rich-Plasma TherapyAlso: platelet concentratesObjective: 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. | Procedure or surgery | Neuromodulation + PRP Therapy Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 0 Weeks
Improvement in the Visual Analog Scale (VAS)
Visual Analog Scale (VAS)
Time frame: 2 Weeks
Improvement in the Visual Analog Scale (VAS)
Visual Analog Scale (VAS)
Time frame: 3 Months
Improvement in the Visual Analog Scale (VAS)
Visual Analog Scale (VAS)
Time frame: 6 Months
Improvement in the Visual Analog Scale (VAS)
Visual Analog Scale (VAS)
Time frame: 12 Months
Improvement in the Visual Analog Scale (VAS)
Oswestry Disability Index (ODI)
Time frame: 0 weeks
Improvement in the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Time frame: 2 weeks
Improvement in the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Time frame: 3 Months
Improvement in the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Time frame: 6 Months
Improvement in the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Time frame: 12 Months
Improvement in the Oswestry Disability Index (ODI)
Hospital Anxiety Depression (HAD)
Time frame: 0 Weeks
Improvement in the Hospital Anxiety Depression (HAD)
Hospital Anxiety Depression (HAD)
Time frame: 2 Weeks
Improvement in the Hospital Anxiety Depression (HAD)
Hospital Anxiety Depression (HAD)
Time frame: 3 Months
Improvement in the Hospital Anxiety Depression (HAD)
Hospital Anxiety Depression (HAD)
Time frame: 6 Months
Improvement in the Hospital Anxiety Depression (HAD)
Hospital Anxiety Depression (HAD)
Time frame: 12 Months
Improvement in the Hospital Anxiety Depression (HAD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 30288088Ho 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.
- Background: PubMed 25395117Deer 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.
- Background: PubMed 24192391Sundman 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahzad Anwar, MBBS, DOM principal investigator
Iffat Anwar Medical Complex, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAIDs (Nonsteroidal Anti-Inflammatory Drugs):, Standard Physical Therapy and Neuromodulation via Dorsal Root Ganglion (DRG): in people with Chronic Low Back Pain (CLBP), run by Iffat Anwar Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahzad Anwar, MBBS, DOM (+923009400049, shahzadtirmzi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 0 Weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453291, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.