Health TrialsbyHealthPanel

Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain

ConditionMulti-Organ Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-70
SponsorIffat Anwar Medical Complex

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Refractory low back pain due to multifidus dysfunction.

Pain persisting for more than 6 months despite conventional treatments.

Ability to provide informed consent.

Disqualifiers

Previous spinal surgery within the last year.

Current use of systemic steroids or immunosuppressive medications.

Known bleeding disorders or anticoagulant therapy.

Pregnancy or lactation.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Pulsed RF Neuromodulation

    Procedure/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 Injection

    Biological/Vaccine

    Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.

  • Physiotherapy Alone

    Procedure/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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 2 interventions
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain Visual Analog Scale (0-10)

Change in pain intensity from baseline

Time frame
2 Weeks
2

Pain Visual Analog Scale (0-10)

Change in pain intensity from baseline

Time frame
3 Months
3

Pain Visual Analog Scale (0-10)

Change in pain intensity from baseline

Time frame
6 Months
4

Pain Visual Analog Scale (0-10)

Change in pain intensity from baseline

Time frame
1 Year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iffat Anwar Medical Complex

Lead sponsor

Source ClinicalTrials.gov
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