Multi-Organ DisorderEarly Phase 1MultifidusNCT06524531
Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain
A Early Phase 1 study testing Pulsed RF Neuromodulation, Leukocyte-Rich PRP Injection and Physiotherapy Alone in people with Multi-Organ Disorder, run by Iffat Anwar Medical Complex at 1 site in Pakistan.
Trial summary
This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Multi-Organ Disorder
- What is being tested?
- Pulsed RF Neuromodulation, Leukocyte-Rich PRP Injection and Physiotherapy Alone
- Type of treatment
- 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 30 Dec 2025
- Phase
- Early Phase 1
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory low back pain due to multifidus dysfunction.
- Pain persisting for more than 6 months despite conventional treatments.
- Ability to provide informed consent.
Who cannot join
- Previous spinal surgery within the last year.
- Current use of systemic steroids or immunosuppressive medications.
- Known bleeding disorders or anticoagulant therapy.
- Pregnancy or lactation.
- Severe psychiatric or cognitive disorders.
- Any Congenital or Non-congenital disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Iffat Anwar Medical Complex
Lahore, Punjab Province, 54000
Shahzad Anwar, DOM, MBBS, +92 345 8477000, shahzadtirmzi@yahoo.com
Shahzad Anwar, DOM, MBBS
About this study
Official title: Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction
This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. The trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy.
Read the detailed description
Low back pain is a common condition, often associated with multifidus muscle dysfunction, which can result from aging, obesity, or limited movement. This dysfunction is characterized by fatty infiltration and loss of muscle function. Surgical procedures involving posterior or transpedicular screw insertion can exacerbate this issue by damaging the multifidus muscle, leading to persistent pain.
This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally, with each side receiving treatment for 6 minutes. In addition, leukocyte-rich PRP will be injected into the multifidus muscle, and patients will undergo a physiotherapy regimen. The primary outcomes will be compared with those of a control group receiving only physical therapy.
- Conditions
- Multi-Organ Disorder
- Being tested
- Pulsed RF Neuromodulation, Leukocyte-Rich PRP Injection, Physiotherapy Alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed RF NeuromodulationProcedure or surgery
RF neuromodulation will be applied to the L2 and L3 segments bilaterally. Each segment will receive treatment for 6 minutes, either sequentially or simultaneously on both sides.
Leukocyte-Rich PRP InjectionBiological
Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.
Physiotherapy AloneProcedure or surgery
Standard physiotherapy regimen tailored to each participant's needs. This may include exercises to improve flexibility, strength, and endurance of the back muscles, as well as education on posture and body mechanics.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each.
Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen. Receives: Procedure: Pulsed RF Neuromodulation; Biological: Leukocyte-Rich PRP Injection |
| Control Group | Experimental | Physiotherapy: Standard physiotherapy regimen only Receives: Procedure: Physiotherapy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Measured: 2 Weeks
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Measured: 3 Months
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Measured: 6 Months
Pain Visual Analog Scale (0-10)
Change in pain intensity from baseline
Measured: 1 Year
Oswestry Disability Index (0-50)
Change in disability index from baseline
Measured: 2 Weeks
Oswestry Disability Index (0-50)
Change in disability index from baseline
Measured: 3 Months
Oswestry Disability Index (0-50)
Change in disability index from baseline
Measured: 6 Months
Oswestry Disability Index (0-50)
Change in disability index from baseline
Measured: 1 Year
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Measured: 2 Weeks
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Measured: 3 Months
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Measured: 6 Months
Hospital Anxiety and Depression Scale (0-14)
Change in anxiety and depression levels from baseline
Measured: 1 Year
Quality of Life (0-100)
Change in Quality of life from baseline
Measured: 2 Weeks
Quality of Life (0-100)
Change in Quality of life from baseline
Measured: 3 Months
Quality of Life (0-100)
Change in Quality of life from baseline
Measured: 6 Months
Quality of Life (0-100)
Change in Quality of life from baseline
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start10 Jul 2024
- Primary completion10 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-Organ DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524531
- Sponsor's protocol ID
- IAMC003
- Acronym
- Multifidus
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction
- ClinicalTrials.gov ID
- NCT06524531
- Acronym / sponsor ID
- Multifidus / IAMC003
- Conditions
- Multi-Organ Disorder
- Phase
- Early Phase 1
- 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
- 10 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jul 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 check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. The trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy.
Detailed description
Low back pain is a common condition, often associated with multifidus muscle dysfunction, which can result from aging, obesity, or limited movement. This dysfunction is characterized by fatty infiltration and loss of muscle function. Surgical procedures involving posterior or transpedicular screw insertion can exacerbate this issue by damaging the multifidus muscle, leading to persistent pain.
This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally, with each side receiving treatment for 6 minutes. In addition, leukocyte-rich PRP will be injected into the multifidus muscle, and patients will undergo a physiotherapy regimen. The primary outcomes will be compared with those of a control group receiving only physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Pulsed RF Neuromodulation, Biological: Leukocyte-Rich PRP InjectionPulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each. Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen. |
| Control Group | Experimental | Procedure: Physiotherapy AlonePhysiotherapy: Standard physiotherapy regimen only |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Refractory low back pain due to multifidus dysfunction.
- Pain persisting for more than 6 months despite conventional treatments.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- Previous spinal surgery within the last year.
- Current use of systemic steroids or immunosuppressive medications.
- Known bleeding disorders or anticoagulant therapy.
- Pregnancy or lactation.
- Severe psychiatric or cognitive disorders.
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 |
|---|---|---|
| Pulsed RF NeuromodulationRF neuromodulation will be applied to the L2 and L3 segments bilaterally. Each segment will receive treatment for 6 minutes, either sequentially or simultaneously on both sides. | Procedure or surgery | Experimental Group |
| Leukocyte-Rich PRP InjectionLeukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels. | Biological | Experimental Group |
| Physiotherapy AloneStandard physiotherapy regimen tailored to each participant's needs. This may include exercises to improve flexibility, strength, and endurance of the back muscles, as well as education on posture and body mechanics. | Procedure or surgery | Control Group |
Primary outcome
Pain Visual Analog Scale (0-10)
Time frame: 2 Weeks
Change in pain intensity from baseline
Pain Visual Analog Scale (0-10)
Time frame: 3 Months
Change in pain intensity from baseline
Pain Visual Analog Scale (0-10)
Time frame: 6 Months
Change in pain intensity from baseline
Pain Visual Analog Scale (0-10)
Time frame: 1 Year
Change in pain intensity from baseline
Oswestry Disability Index (0-50)
Time frame: 2 Weeks
Change in disability index from baseline
Oswestry Disability Index (0-50)
Time frame: 3 Months
Change in disability index from baseline
Oswestry Disability Index (0-50)
Time frame: 6 Months
Change in disability index from baseline
Oswestry Disability Index (0-50)
Time frame: 1 Year
Change in disability index from baseline
Hospital Anxiety and Depression Scale (0-14)
Time frame: 2 Weeks
Change in anxiety and depression levels from baseline
Hospital Anxiety and Depression Scale (0-14)
Time frame: 3 Months
Change in anxiety and depression levels from baseline
Hospital Anxiety and Depression Scale (0-14)
Time frame: 6 Months
Change in anxiety and depression levels from baseline
Hospital Anxiety and Depression Scale (0-14)
Time frame: 1 Year
Change in anxiety and depression levels from baseline
Quality of Life (0-100)
Time frame: 2 Weeks
Change in Quality of life from baseline
Quality of Life (0-100)
Time frame: 3 Months
Change in Quality of life from baseline
Quality of Life (0-100)
Time frame: 6 Months
Change in Quality of life from baseline
Quality of Life (0-100)
Time frame: 1 Year
Change in Quality of life from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pulsed RF Neuromodulation, Leukocyte-Rich PRP Injection and Physiotherapy Alone in people with Multi-Organ Disorder, 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 3 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 19 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale (0-10) (time frame: 2 Weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.